Article

Nonabsorbable Versus Absorbable Suture Anchors for Open Bankart RepairA Prospective, Randomized Comparison

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Abstract

Suture anchors facilitate the surgical repair of capsuloligamentous structures to bone. Bioabsorbable suture anchors, which obviate potential pitfalls in the periarticular use of permanent implants, have recently become available. We randomly assigned 40 patients to undergo modified Bankart shoulder repairs with either nonabsorbable or absorbable suture anchors. The patients had a history of recurrent traumatic anterior instability that had not improved with nonoperative management. The average patient age was 22 years (range, 17 to 46), and the average preoperative Rowe score was 47 points in the nonabsorbable anchor group and 47 points in the absorbable anchor group. Average postoperative Rowe scores were 96 and 93 points, respectively. There was one failed result in the nonabsorbable anchor group and two in the absorbable anchor group. No statistically significant subjective or objective differences were found at an average of 25 months postoperatively. Our results reveal that, in this application, bioabsorbable suture anchors are a viable option for the repair of soft tissue to bone.

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... Since absorbable suture anchors showed similar pull-out strengths as transosseous fixation they became more common in orthopedic surgery. Their use decreased operation time as well as violated osseous surface [20]. In shoulder studies, Warme et al. found no significant differences in the functional outcome between absorbable and non-absorbable anchor material [20]. ...
... Their use decreased operation time as well as violated osseous surface [20]. In shoulder studies, Warme et al. found no significant differences in the functional outcome between absorbable and non-absorbable anchor material [20]. However, improper use of both anchor types led to articular compromise if implants migrate: The postoperative radiographic assessment showed a doubling of anchor holes' size after 6 months and focal osteonecrosis at drilling site [21]. ...
... However, improper use of both anchor types led to articular compromise if implants migrate: The postoperative radiographic assessment showed a doubling of anchor holes' size after 6 months and focal osteonecrosis at drilling site [21]. There is some normalization using absorbable anchors where biodegradation can vary from 3 months to over 32 months [20,22]. Since trauma in our case occurred 9 weeks postoperatively and radiographic assessment showed that the anchor material was not degraded or migrated, long-term changes are unlikely to play an important role. ...
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Introduction: Fractures at the anchor site following arthroscopic rotator cuff repair are rare and only a few case reports have been described. We report two additional well-documented cases of this uncommon post-operative complication and provide a review of the current literature. Case Report: A 48-year-old male underwent arthroscopic rotator cuff repair (ARCR) due to a massive rotator cuff tear. Nine weeks postoperatively, the patient suffered a humeral head fracture at the anchor site of the ARCR after trauma. Despite subsequent surgical treatment with open reduction and internal fixation, the patient demonstrates with excellent functional outcome scores at 2-year follow-up. Conclusion: Humeral head fractures are a rare complication after ARCR. The use of intraosseous anchors requires careful consideration regarding positioning and quantity used.
... The following generation of implants was composed of poly-l-lactic acid and did not degrade as fast as polyglycolic acid [14, 15], which allowed sufficient healing before reabsorption of the anchor [16]. Anchor degradation should ideally occur as soft tissue healing progresses [21]. ...
... Potential causal factors such as alteration of the implant due to sterilization, focal necrosis due to drilling or micromotion of the anchor should also be considered [16, 27]. Numerous studies have shown that biodegradable materials are a good option in capsuloligamentous refixation [2], exhibiting multiple advantages and a low incidence of complications [21, 27]. The pathways described in the present and previous cases demonstrate similarities concerning the time between surgery and symptoms, radiological signs, treatment and recovery. ...
... Bioabsorbable suture anchors can offer the advantage of reabsorption and may avoid certain problems inherent to metal anchors, such as artifacts on MRI scans [7, 8, 19, 20]. Additionally, bioabsorbable sutures facilitate revision surgery, avoid the risk of dislocation with permanent fixation gadgets and posses equivalent primary stability to non-degradable suture anchors [5, 21]. ...
Article
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Biodegradable implants lead to problems such as cyst formation, soft-tissue inflammation, loose implant fragments or local osteolysis. This report represents the first published case of an intraosseous foreign body granuloma in the humeral head after arthroscopic rotator cuff tear fixation with a poly-L: -lactide (PLLA) suture anchor. A 48-year-old female patient presented with pain in her right shoulder. A refixation of her right supraspinatus tendon with a biodegradable suture anchor was performed 11 months ago at an external hospital. Laboratory tests showed normal values for C-reactive protein, leukocytes and the erythrocyte sedimentation rate. No signs of infection or instability were noted. The visual analogue scale (VAS) was 8, the simple shoulder test (SST) was 4 and the American shoulder and elbow surgeons score (ASES) was 44. Plain radiographs showed high lucency in the area of the tuberculum majus. MRI showed an intra- and extraosseous mass surrounded by fluid in this area. Surgical care involved arthroscopic debridement and removal of the suture anchor. Histological examination revealed a foreign body granuloma. At the 18-month follow-up the patient was nearly pain-free. The VAS was 2, SST was 10 and ASES was 88. Foreign body granulomas are a well known but rarely described complication that arises after the use of biodegradable suture anchors in shoulder surgery. Every patient presenting with shoulder pain after usage of a biodegradable fixation material should be evaluated closely. Orthopaedic surgeons should be aware of the possibility of delayed foreign body reactions, especially after using PLLA anchors.
... They were associated with complications like migration, cartilage erosion, difficulty in revision and MR imaging 5,[11][12][13][14] . Still, they are one of the commonest and most economical suture anchors in use 15 . Different comparative studies have reported better or comparable clinical functional outcomes of the knotted metal anchors in comparison with biocompatible anchors 14,[16][17][18][19] . ...
... There are certain disadvantages of metal anchors which led to the evolution of different anchor materials over a period of time, yet they still remain popular and are less expensive compared to other anchor devices 5,15,19 . ...
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Introduction Both knotted all suture anchors and metal anchors are used for arthroscopic Bankart repair. We retrospectively evaluated and compared clinical and functional outcomes after arthroscopic Bankart repair using the knotted all-suture anchors and knotted metal anchors. Materials and methods In a retrospective cohort analysis, patients who underwent arthroscopic Bankart repair without any concomitant additional lesion repair using either all-suture anchors or metal anchors, between January 2015 and May 2018 were identified. Their pre- and post-operative functional and clinical outcomes were compared using Rowe and WOSI scores. The recurrence rate in the two groups was also compared. Results A total of 41 patients in all suture anchors group and 47 in the metal anchors group were identified as per inclusion and exclusion criteria. The demographic profile of both groups was comparable. There was no significant difference in clinical and functional outcome between the two suture anchor groups as per Rowe (pre-operative 40.13+6.51 vs 38.09+6.24 and post-operative 2 years 93.28+7.09 vs 92.55+9.2) and WOSI (pre-operative 943.05+216.64 vs 977.55+165.46 and post-operative 2 years 278.21+227.56 vs 270.94+186.25) scores. There was a significant improvement in both the groups between preoperative and post-operative ROWE and WOSI scores at 6 months and 2 years follow-up as compared to pre-operative scores (p<0.001). Re-dislocation rates were also comparable (4.8% vs 6.3%). Conclusion All-suture anchors showed comparable clinical and functional results as the metal anchors for arthroscopic Bankart repair at two-year follow-up.
... This resulted in a total of 22 RCTs that compare surgical interventions for shoulder instability. (Fig. 1) The studies originate from Sweden (n ¼ 5), 21,25,31,35,36 Denmark (n ¼ 1), 24 the USA (n ¼ 3), 19,32,38 23,27,29 Brazil (n ¼ 2), 18,30 Turkey (n ¼ 1) 26 and Iran (n ¼ 1). 39 The studies compare techniques regarding different sutures/anchors, 25,28,30,31,[36][37][38] open/closed stabilization techniques, 18,19,[22][23][24]26,29,32,33,35,39 arthroscopic Bankart repair versus joint lavage 34 and variations of arthroscopic Bankart repairs. ...
... (Fig. 1) The studies originate from Sweden (n ¼ 5), 21,25,31,35,36 Denmark (n ¼ 1), 24 the USA (n ¼ 3), 19,32,38 23,27,29 Brazil (n ¼ 2), 18,30 Turkey (n ¼ 1) 26 and Iran (n ¼ 1). 39 The studies compare techniques regarding different sutures/anchors, 25,28,30,31,[36][37][38] open/closed stabilization techniques, 18,19,[22][23][24]26,29,32,33,35,39 arthroscopic Bankart repair versus joint lavage 34 and variations of arthroscopic Bankart repairs. 20,27 The study characteristics are summarized in Appendix 3. ...
Article
Background: The present study aimed to evaluate the methodological quality and determine the quality of reporting of randomized controlled trials (RCTs) that assess surgical treatment for shoulder instability. Methods: A Cochrane, Pubmed, EMBASE and Trip database search was performed, including the relevant literature, regarding RCTs that report on shoulder instability published between January 1994 and January 2017. Methodological quality was assessed with a modification of the Checklist to Evaluate A Report of a Nonpharmacologic Trial (CLEAR-NPT). Points were assigned based on 18 items regarding patient characteristics, randomization, care provider characteristics, surgical details and blinding, with a total score ranging from 0 points to 18 points. Missing items were verified with the corresponding authors of the studies. Quality of reporting corresponds to the total scores including the items that were additionally provided by the authors. Results: We included 22 studies. Of these, nine corresponding authors provided additional information. The average methodological quality was 16.9 points (11 studies) and the average quality of reporting was 9.5 points (22 studies). Items scoring worst included information regarding the surgeon's experience, the patients' level of activity, comorbidities, analyzing according to 'intention-to-treat' principles, and blinding of care providers, participants and assessors. Conclusions: RCTs reporting on shoulder instability surgery are well performed but poorly reported.
... Labral repair and capsulolabral reconstruction can effectively be treated with suture anchors by both arthroscopic and open methods. [1][2][3] Suture anchors are low-profile fixation devices that can minimize articular surface compromise and afford an anatomic reconstruction of the labrum and glenohumeral ligament complex. Although the use of suture anchors has become increasingly common to obtain stable fixation and healing at the bone-tendon interface in rotator cuff repair, critical distinctions exist between this function and their implementation in labral repair and capsulolabral reconstruction. ...
... Bioabsorbable suture anchors have several properties that make them a potentially attractive alternative to their nonabsorbable equivalents. 1,2,18 These include greater ease of postoperative imaging without the artifact associated with metallic devices as well as the potential restoration of bone stock after resorption. The resorption of suture anchors is a critical benefit, although not free of potential complications, because it may ease revision surgery, which is not uncommon when treating complex capsulolabral pathology. ...
Article
Treatment of glenohumeral instability and capsulolabral pathology continues to evolve as arthroscopic techniques improve. A growing body of biomechanical and clinical research provides an enhanced perspective on results obtained with both arthroscopic and open treatment of these conditions. Labral repair and capsulolabral reconstruction can effectively be treated with suture anchors by both arthroscopic and open methods. Suture anchors are low-profile fixation devices that can minimize articular surface compromise and afford an anatomic reconstruction of the labrum and glenohumeral ligament complex. Although the use of suture anchors has become increasingly common to obtain stable fixation and healing at the bone-tendon interface in rotator cuff repair, critical distinctions exist between this function and their implementation in labral repair and capsulolabral reconstruction. This article examines the technical aspects of labral repair and capsulolabral reconstruction with metallic and bioabsorbable suture anchors. The emphasis is on implant options, technical advantages, potential limitations, and relevant biomechanical considerations to better achieve an optimal outcome.
... Finally, similar studies in other fields like orthopaedic surgery, urology, and obstetrics found similar results with no significant differences between PDS and nylon [10][11][12]. ...
Article
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Background The ability to attain accurate and predictable changes in the contour and position of the nasal tip is still one of challenging aspects of rhinoplasty; however, little evidence supports the choice of suture material for this technique in rhinoplasty. This study was conducted to compare the effect of nylon and polydioxanone(PDS) on tip projection and rotation of rhinoplasty patients. Methods Sixty rhinoplasty candidates were included in this clinical trial study and evaluated prospectively. They were randomly allocated to two groups according to the use of nylon or PDS. The outcome measures were achieving and maintaining tip projection and rotation in the long term. Standardized photos were taken before and after the surgery to compare the final outcomes between the two groups, which were evaluated for tip rotation and projection. Moreover, visual analogue scale (VAS) and Standardized Cosmesis and Health Nasal Outcomes Survey (SCHONS) were used for assessment of patients’ satisfaction with beauty and nasal obstruction. Results Thirty patients underwent surgery using nylon sutures, while the PDS was used in the same number of cases. Tip rotation, tip projection, and other characteristics were not significantly different between the two groups preoperatively. None of evaluated variables was significantly different between the two groups. Conclusions It appears that both nylon and PDS are appropriate suture materials in maintaining tip projection and rotation in the tongue-in-groove technique. Using absorbable sutures may decrease unwanted reactions in longer patient follow-ups. Trial registration Clinical trial Registration number: IRCT20080820001056N4 Level of Evidence: Level I, therapeutic study
... 4,10,25 When it comes to redislocation and clinical outcomes, both nonabsorbable and absorbable anchors have been reported to be similar with recurrence rate ranging from 0% to 35% depending on the type and manufactures. 2,5,9,12,14e18,20,21,23,24,35e38 Thal et al 37 41 compared nonabsorbable polyacetyl vs absorbable polyglycolic acid (PGA) and trimethylene carbonate. These studies did not find any differences in redislocation rates or clinical outcomes in Rowe, American Shoulder and Elbow Surgeons standardized assessment, Oxford Instability Shoulder Score, and visual analog score between nonabsorbable and absorbable anchors. ...
Article
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Background Biodegradable suture anchors are associated with higher redislocation rates. This study examined whether the biocompatibility and/or biomechanical properties of suture anchors contribute to the increase in complications. Methods Human glenohumeral capsule cells were cultured with 4 types of suture anchors, Opus LabraFix (titanium alloy; ArthroCare, Austin, TX, USA), PushLock (poly-ether-ether-ketone; Arthrex, Naples, FL, USA), BioKnotless (poly-l-lactic acid; DePuy Mitek, Warsaw, IN, USA), and Suretac II (polyglycolic acid; Smith & Nephew, London, UK), to measure cell viability and pH. Four groups of 6 ovine shoulders were used to repair the labrum, which was completely detached from the glenoid rim anteroinferiorly and reattached with 2 suture anchors and subject to failure load testing. Results In cell culture, BioKnotless at 48 and 72 hours (85.2% ± 2.1% and 84.5% ± 3.6%) and Suretac II groups (33.9% ± 3.1% and 42.8% ± 6.4%) had fewer viable cells compared with control (P = .048). The pH of Suretac II was lower than control (7.51 to 7.65) at 24 hours (7.31 ± 0.08, P = .049), 48 hours (7.25 ± 0.02, P = .046), and 72 hours (7.29 ± 0.04, P = .04). During mechanical testing, 83% of repairs failed by the capsule tearing. Among the anchors, the BioKnotless repair group had a significantly lower failure load (37 ± 5 N) compared with the PushLock (61 ± 7 N), Opus (60 ± 6 N), and Suretac II (57 ± 7 N) groups (P = .038). Conclusion BioKnotless and Suretac II anchors are cytotoxic. The BioKnotless biodegradable anchor has significantly lower failure load. Absorbable suture anchors may cause higher redislocation of arthroscopic Bankart repair.
... A number of the strongest anchors released in recent years are biodegradable including the Biozip (2003; Stryker Corporation, Kalamazoo, USA) and SwiveLock C (2003; Arthrex), likely demonstrating an increased quality of these polymers with modern production (F.A. . Increased length of molecular weight polymer chains are known to increase strength (Warme et al., 1999). The Biozip is the strongest anchor recorded at 817 N pull out strength, made of slowly degrading PLLA, it is 5 mm wide and recommended for insertion into a pilot hole made with an awl and is mostly used around the shoulder. ...
Article
The suture anchor allows secure fixation of soft tissue to bone and has become an invaluable tool for the orthopaedic surgeon. The original suture anchor was developed over 3 decades ago when a suture was bonded to a headless screw. Since then anchors have undergone a wide variety of design modifications to increase strength and allow for new applications based on biomechanical and clinical evidence. The suture anchor chain consists of the anchor to bone fixation, anchor suture interface, suture itself and suture to soft tissue interface. The early suture anchors failed most commonly from anchor pull out or breakage, with the strongest early design being a bone-screw-suture complex. Early concerns of metalwork complications saw the introduction of biodegradable suture anchors, originally lactic acid polymers and then osteoconductive bio-composites. Improvements in anchor design saw the suture become the main link of failure until the advent of novel suture materials made of ultrahigh molecular weight polyethylene. A form failure of suture at the anchor eyelet via cut-out led to redesign of the anchor suture interface with novel eyelet designs. Further innovations in the anchor suture interface have seen the advent of knotless anchors, especially useful in arthroscopic surgery. The newest products are all-suture anchors which show impressive strength whilst reducing the iatrogenic damage caused by insertion. The further biomechanical development of suture anchors is likely to produce new designs that continue to increase strength whilst managing size requirements for tailored clinical applications.
... [41][42][43][44][45] Twelve RCTs focused on chronic post-traumatic shoulder instability, of which four RCTs compared open labral repair with arthroscopic labral repair 2 5 46 47 and three compared absorbable with non-absorbable suture anchors. [48][49][50] Mean participant age ranged from 20.3 to 36 years. The mean follow-up ranged from 12 to 143 months. ...
Article
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Objective To review and compare treatments (1) after primary traumatic shoulder dislocation aimed at minimising the risk of chronic shoulder instability and (2) for chronic post-traumatic shoulder instability. Design Intervention systematic review with random effects network meta-analysis and direct comparison meta-analyses. Data sources Electronic databases (Ovid MEDLINE, Cochrane Clinical Trials Register, Cochrane Database of Systematic Reviews, Embase, Scopus, CINAHL, Ovid MEDLINE Epub Ahead of Print, In-Process & Other Non-Indexed Citations, Ovid MEDLINE Daily, DARE, HTA, NHSEED, Web of Science) and reference lists were searched from inception to 15 January 2018. Eligibility criteria for selecting studies Randomised trials comparing any interventions either after a first-time, traumatic shoulder dislocation or chronic post-traumatic shoulder instability, with a shoulder instability, function or quality of life outcome. Results Twenty-two randomised controlled trials were included. There was moderate quality evidence suggesting that labrum repair reduced the risk of future shoulder dislocation (relative risk 0.15; 95% CI 0.03 to 0.8, p=0.026), and that with non-surgical management 47% of patients did not experience shoulder redislocation. Very low to low-quality evidence suggested no benefit of immobilisation in external rotation versus internal rotation. There was low-quality evidence that an open procedure was superior to arthroscopic surgery for preventing shoulder redislocations. Conclusions There was moderate-quality evidence that half of the patients managed with physiotherapy after a first-time traumatic shoulder dislocation did not experience recurrent shoulder dislocations. If chronic instability develops, surgery could be considered. There was no evidence regarding the effectiveness of surgical management for post-traumatic chronic shoulder instability.
... Various researchers have observed small areas of osteolysis after the use of bioabsorbable anchors in shoulder surgery. Biomechanical and biological theories have been proposed to account for these radiographic changes [10,19,22,29]. ...
Article
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Purpose: Various researchers have observed small areas of osteolysis after using bioabsorbable anchors in shoulder surgeries. The purpose of this study is to determine whether radiographic perianchor radiolucent rings after rotator cuff repair are associated with the failure of repair and also assess their clinical implications. Further, the most frequent location of the radiolucent rings in the double-row suture bridge configuration was also assessed. Methods: One hundred and twenty-nine consecutive patients who underwent arthroscopic rotator cuff repair by suture bridge technique were retrospectively evaluated radiographically and clinically. The number and size of the rings that appeared at each follow-up were recorded. Also, the locations of each ring were recorded as anterior, middle or posterior, and medial or lateral according to the construct of the anchors used for suture bridge technique. The size of the tear, the number of anchors used and age of the patients were compared. Re-tear rates according to ultrasound examinations were also analyzed. Results: After rotator cuff repair, the mean American Shoulder and Elbow Surgeons (ASES) score increased from 46.7 to 88.0 and the overall re-tear rate was 8.5% (11 cases). Seventy-three patients (56.6%) showed RR (total number of 99 rings) at least once during the course of their follow-up and the rings appeared at a mean period of 18.2 months after surgery. Mean size of the rings initially was 5.6 mm and the rings increased or decreased in mean size of 0.4 mm during mean follow-up of 37 months. No correlation was seen with the number of RRs and the rate of re-tears, number of anchors, size of tears, and clinical outcome as determined by the ASES score. Radiolucent ring measurement reproducibility was confirmed by independent, repeated measurements. The rings appeared mostly at anteromedial anchors (75 rings, 75.8%) and the authors suggest that mechanical factors may play a role for the cause of radiolucent rings. Conclusions: The number and the size of RRs around bioabsorbable anchors after rotator cuff repair do not appear to adversely affect the healing and clinical outcome of ARCR. Most radiolucent rings appeared at anteromedial anchors, indicating that mechanical factors may play a role for the radiolucencies. Level of evidence: Case series, level IV.
... All 96 articles were individually reviewed by 2 reviewers, resulting in 29 articles that met the inclusion criteria and were included in this report ( Figure 1). [2][3][4][5][7][8][9][10][11][12][13][14][15][16][17][18][19][20][22][23][24][25][26][27][28][29][30][31][32][33] Study Characteristics ...
Article
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Background: Results of open Bankart repair have been well reported. However, less information is available outlining the timetable for return to play (RTP) in athletes after this procedure. Purpose: To review the current literature regarding (1) the timetable recommended for athletes to RTP after an open Bankart repair and (2) the objective criteria on which the decision to allow an athlete to RTP is based. Study Design: Systematic review; Level of evidence, 4. Methods: A comprehensive literature search was conducted of all relevant English-language articles using the electronic databases OVID and PubMed between the years 1947 and 2012 to identify open Bankart repair. Two reviewers screened articles for eligibility based on the following criteria: (1) an open Bankart repair, (2) a minimum follow-up of at least 8 months, (3) any report that described the procedure in athletes, and (4) any report that described the time for an athlete to RTP. All relevant data were collected and analyzed with regard to number of patients; mean follow-up; Rowe, Constant, and American Shoulder and Elbow (ASES) scores; redislocation rate; and return-to-sport timing. Results: In all, 559 relevant citations were identified, of which 29 articles met the inclusion criteria. The mean follow-up was 51.7 months (range, 8-162 months), and the mean age was 25.9 years (range, 21-31 years). The average Rowe score for all studies was 86.9 (range, 63-90). The average redislocation rate was 5.3%. Twenty-six of 29 studies cited a specific timetable for unrestricted RTP, with an average of 23.2 weeks (range, 12-36 weeks). Only 38% of authors reported sport-specific criteria for return to competition, with the majority allowing return to noncontact sports at 12 to 16 weeks, and the resumption of throwing/contact sports by 24 weeks. Three reports described specific functional parameters for RTP. Conclusion: The current review summarized return-to-play guidelines for athletic competition after open Bankart repair. These data may provide general guidelines to aid surgeons when determining the appropriate timetable to allow an athlete to return to unrestricted competition.
... The advent of suture anchors has allowed for the replacement of transosseous tunnels, especially in cases of glenohumeral instability. Using suture anchors on the glenoid rim or in the humerus eases and diminishes the time required for surgical repair of the capsule ligament, regardless of whether these are treated through open or arthroscopic routes [1][2][3][4][5][6][7][8]. However, despite the advantages provided by suture anchors, complications can still develop. ...
... Finally, bioabsorbable devices are more expensive than metallic anchors. 54,55 In this systematic review, we compared data of patients who underwent arthroscopic shoulder stabilization with either absorbable or nonabsorbable suture anchors to investigate the possible differences in the clinical outcomes recorded over time. With regard to the effectiveness of these devices, all the studies investigating a specific class of anchor material 19,[22][23][24][25][26][27] reported significantly improved clinical outcome values recorded during follow-up when compared with baseline. ...
Article
Purpose To investigate whether there are any differences in clinical outcomes and complications between absorbable and nonabsorbable suture anchors in the treatment of shoulder instability. Methods We performed a comprehensive search of Medline, CINAHL (Cumulative Index to Nursing and Allied Health Literature), Embase, and the Cochrane Central Registry of Controlled Trials, from inception of the databases, using various combinations of keywords. Only studies focusing on clinical outcomes of patients who underwent arthroscopic shoulder stabilization with suture anchors were selected. Two authors (R.P. and L.D.B.) then evaluated the methodologic quality of each article using the Coleman Methodology Score. Results Ten articles were included. Four were prospective randomized studies, 2 were prospective cohort studies, and 4 were case series. The mean modified Coleman Methodology Score was 76.2. Conclusions Given the overall good results reported after arthroscopic stabilization of the shoulder using different suture anchors, it is not possible to draw a definite and solid suggestion on which class of device is better advised for routine use. Thus the decision to use one of the anchor systems available may mostly depend on its cost-effectiveness, which should be the focus of future comprehensive research. Level of Evidence Level IV, systematic review of Level I to IV studies.
... Foi verificado em estudos radiográficos, tomando-se como referências as variações do diâmetro dos orifícios de inserção de âncoras absorvíveis em 10 pacientes e, com o seguimento máximo de 38 meses, que os sinais de substituição por osso só foram observados a partir de um ano de pós-operatório (11) . Entretanto, com seis meses observa-se que a resistência é semelhante, tanto com âncoras absorvíveis, como não absorvíveis (12) . ...
Article
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Unlabelled: To identify the complications concerning the use of metal anchors in shoulder arthroscopic procedures. Methods: 28 shoulders of 28 patients (23 male and 5 female) have been re-operated in the period between December 1997 and August 2007, at Hospital Ortopédico, Belo Horizonte Hospital and Military Police Hospital in Belo Horizonte, MG, as a result of complications such as loose anchors and prominent anchors. The primary surgeries intended to treat 20 anterior traumatic instabilities (71.5%), one posterior instability (3.5%), one slap injury (3.5%), six procedures for treating injuries on the rotator cuff (21.5%). We used the X-ray classification suggested by Samilson and Prieto and Outerbridge arthroscopic classification for assessing patients' degree of arthrosis. All patients were evaluated by the UCLA (University of California at Los Angeles) index criteria. Results: In all patients, arthroscopic reviews were made. In two cases, after anchors removal, clinical signs of instability were seen, leading to the decision of providing open stabilization by Latarjet-Patte technique. Conclusion: the complications with metallic-suture anchors result from inappropriate surgical techniques applied in arthroscopy.
... Foi verificado em estudos radiográficos, tomando-se como referências as variações do diâmetro dos orifícios de inserção de âncoras absorvíveis em 10 pacientes e, com o seguimento máximo de 38 meses, que os sinais de substituição por osso só foram observados a partir de um ano de pós-operatório (11) . Entretanto, com seis meses observa-se que a resistência é semelhante, tanto com âncoras absorvíveis, como não absorvíveis (12) . ...
Article
Full-text available
Objective: to identify the complications concerning the use of metal anchors in shoulder arthroscopic procedures. Methods: 28 shoulders of 28 patients (23 male and 5 female) have been re-op- erated in the period between December 1997 and August 2007, at Hospital Ortopédico, Belo Horizonte Hospital and Military Police Hospital in Belo Horizonte, MG, as a result of complica- tions such as loose anchors and prominent anchors. The primary surgeries intended to treat 20 anterior traumatic instabilities (71.5%), one posterior instability (3.5%), one slap injury (3.5%), six procedures for treating injuries on the rotator cuff (21.5%). We used the X-ray classification suggested by Samilson and Prieto and Outerbridge arthroscopic classification for assessing patients' degree of arthrosis. All patients were evaluated by the UCLA (University of California at Los Angeles) index criteria. Results: In all patients, arthroscopic reviews were made. In two cases, after anchors removal, clinical signs of instability were seen, leading to the decision of providing open stabilization by Latarjet-Patte technique. Conclusion: the complications with metallic-suture anchors result from inappropriate surgical tech- niques applied in arthroscopy.
... Experimental studies have shown similar pullout strengths and failure rates with metallic and bioabsorbable anchors [8]. Similar functional outcome with the use of both types of anchors in shoulder stabilisation has been showed in a randomised study [9]. However, the exact incidence of pullout of anchors in clinical scenario is unknown. ...
... The effectiveness of bioabsorbable anchors for use in Bankart repairs, as well as in treatment of rotator cuff tears and "SLAP" lesions (i.e., anterior-to-posterior lesions of the superior labrum), is currently under investigation. Warme et al 24 compared the usefulness of bioabsorbable and nonabsorbable suture anchors in a prospective randomized study of open Bankart repairs. At an average follow-up interval of 25 months, there was one failure in the 18 patients treated with nonabsorbable anchors, compared with two failures in 20 patients treated with absorbable anchors. ...
Article
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The use of bioabsorbable implants in orthopaedic surgical procedures is becoming more frequent. Advances in polymer science have allowed the production of implants with the mechanical strength necessary for such procedures. Bioabsorbable materials have been utilized for the fixation of fractures as well as for soft-tissue fixation. These implants offer the advantages of gradual load transfer to the healing tissue, reduced need for hardware removal, and radiolucency, which facilitates postoperative radiographic evaluation. Reported complications with the use of these materials include sterile sinus tract formation, osteolysis, synovitis, and hypertrophic fibrous encapsulation. Further study is required to determine the clinical situations in which these materials are of most benefit.
Chapter
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In contemporary orthopedics, biomechanics of human motion has come to reflect the investigation of the joint’s mechanical properties throughout joint motion. This involves the stresses in the joint throughout motion, the limits of and to motion, and the interaction between these two during joint function. This chapter will discuss these properties with regard to each joint. As such, an appreciation and understanding of joint kinematics, including the native joint, the diseased joint, and the replaced joint is critical for the next stage of improvements in joint arthroplasty. This chapter will outline and discuss the current understanding of how joint kinematics change throughout common pathologies as well as following joint arthroplasty.
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Lumbar fusion often remains the last treatment option for various acute and chronic spinal conditions, including infectious and degenerative diseases. Placement of a cage in the intervertebral space has become a routine clinical treatment for spinal fusion surgery to provide sufficient biomechanical stability, which is required to achieve bony ingrowth of the implant. Routinely used cages for clinical application are made of titanium (Ti) or polyetheretherketone (PEEK). Ti has been used since the 1980s; however, its shortcomings, such as impaired radiographical opacity and higher elastic modulus compared to bone, have led to the development of PEEK cages, which are associated with reduced stress shielding as well as no radiographical artefacts. Since PEEK is bioinert, its osteointegration capacity is limited, which in turn enhances fibrotic tissue formation and peri-implant infections. To address shortcomings of both of these biomaterials, interdisciplinary teams have developed biodegradable cages. Rooted in promising preclinical large animal studies, a hollow cylindrical cage (Hydrosorb™) made of 70:30 poly-l-lactide-co-d, l-lactide acid (PLDLLA) was clinically studied. However, reduced bony integration and unfavourable long-term clinical outcomes prohibited its routine clinical application. More recently, scaffold-guided bone regeneration (SGBR) with application of highly porous biodegradable constructs is emerging. Advancements in additive manufacturing technology now allow the cage designs that match requirements, such as stiffness of surrounding tissues, while providing long-term biomechanical stability. A favourable clinical outcome has been observed in the treatment of various bone defects, particularly for 3D-printed composite scaffolds made of medical-grade polycaprolactone (mPCL) in combination with a ceramic filler material. Therefore, advanced cage design made of mPCL and ceramic may also carry initial high spinal forces up to the time of bony fusion and subsequently resorb without clinical side effects. Furthermore, surface modification of implants is an effective approach to simultaneously reduce microbial infection and improve tissue integration. We present a design concept for a scaffold surface which result in osteoconductive and antimicrobial properties that have the potential to achieve higher rates of fusion and less clinical complications. In this review, we explore the preclinical and clinical studies which used bioresorbable cages. Furthermore, we critically discuss the need for a cutting-edge research program that includes comprehensive preclinical in vitro and in vivo studies to enable successful translation from bench to bedside. We develop such a conceptual framework by examining the state-of-the-art literature and posing the questions that will guide this field in the coming years.
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Suture anchors are widely used for attaching soft tissue to bone due to their ease of insertion, fixation strength, and small size. The past few decades have seen great advances in the materials and designs of suture anchors. They were originally constructed of non-biodegradable metals and polymers, but in recent years there has been a considerable move toward biodegradable polymers. The biodegradable polymer anchors offer advantages such as gradual degradation over time, minimized risk of migration, less complex revision surgery, no need for a removal operation, and improved postsurgical imaging. However, these anchors have lower fixation strength than metal anchors and suffer from adverse local tissue reactions, inflammatory responses, and rapid degradation. Biodegradable metals appear to be ideal candidates for the future of suture anchors. They have high fixation strength and low elastic modulus close to that of bone, which promote osseointegration and allow the design of thinner and lower volume implants. The current article gives an overview of the application and manufacturing of biodegradable metallic suture anchors and summarizes their current concepts and properties in this area of continual development.
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Osteo-synthetics play critical roles in skeletal tissue regeneration by supporting mechanical integrity as well as enhancing cell–tissue interaction to facilitate tissue formation. These roles can be fulfilled by the functional design of porous architectures to provide proper load bearing and mass transportation for the neo tissue formation. These require a simultaneous design for mechanical and mass transport properties. In this chapter, trends for introducing osteo-synthetics in the clinical setting, design parameters for capable implants, and influence of implant physical characteristics on osteointegration are extensively reviewed, followed by introduction of a novel numerical approach to integrate all these factors. We applied a homogenization-based topology optimization scheme to design the three-dimensional unit microstructures for the desired scaffolds. The target effective bulk modulus and isotropic diffusivity are obtained by the optimized porous microstructure. Cross-property bounds between the desired bulk moduli and diffusivities are adapted to determine the defined targets for a given porosity.
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Background: This study evaluated joint stability after surgical repair of cranial cruciate ligament (CrCL)-deficient stifle joints in cats using a novel absorbable polylactide bone anchor in an ex vivo model. Methods: Thirty-six hindlimbs from cats with intact (Gi group) and transected CrCLs were treated with fabellotibial suture alone (GFW group), suture combined with an absorbable polylactide bone anchor (GWD group), or suture combined with a nonabsorbable bone anchor (GFT group), positioned in a limb press with predefined joint angles (stifle joint: 120 ± 5°; hock joint: 120 ± 5°) and loaded with 10%, 20%, and 30% of body mass (BM). Predefined points were measured on lateral radiographs and with a coordinate measurement machine. Distances on radiographs (mm) were measured and angles (°) were calculated to represent the craniocaudal movement and the internal rotation of the tibia. Results: There were no differences for craniocaudal movement between Gi and GFW or GFT, but for GWD regarding angle measurement at 30% BM. For internal rotation, there was no significant difference between Gi and GFW or GWD, but for GFT. Conclusion: The used absorbable polylactide bone-anchor was able to stabilize the stifle joint regarding internal rotation and craniocaudal movement as calculated from distance measurements.
Article
Introduction: The aim of this study is to compare the outcomes of surgical management after primary anterior shoulder dislocation to the outcomes of patients who have surgical stabilization after recurrent anterior shoulder instability. Methods: A Medline (PubMed) search was performed in November of 2016 using the following key terms: shoulder, labrum, Bankart, instability, repair, outcome, recurrent. In May 2017 a Cochrane search was performed using similar key terms to ensure we included all studies. Only level I and II studies were included. Results: There were three studies that compared primary repair to delayed repair. In all three studies, the rate of recurrence was higher in group R than group S. When pooled, there was not a statistically sig- nificant difference between these groups, but there was a slightly higher odds of recurrence in group R (pooled OR 2.08, CI 0.69e6.26, p 1⁄4 0.19). No significant differences were appreciated in functional out- comes or complications in these two groups. Conclusion: Further level I and level II studies to compare surgical treatment after first time and recurrent instability are needed. This study failed to find a statistically significant difference in recurrence rates in patients who had stabilization acutely after a single episode compared to patients with recurrent instability events, although results suggest there may be a small benefit in primary stabilization.
Article
Background: Treatment for shoulder instability has changed significantly over the past decade from open procedures to arthroscopic procedures using a variety of different fixation methods and implants. The development of these implants has been highly influenced by the numerous complications that have arisen using early designs. Methods: A review of the literature was performed to describe the history of shoulder stabilization. Conclusion: As biomedical technology improves, we should continue to see changes to implant design and manufacturing. Having an understanding of the history and evolution of these implants will provide us with context in which to guide future implant design and clinical use. This review article provides a comprehensive overview of the evolution of early shoulder stabilization techniques and implants to the modern implants being used today.
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Bioabsorbable implants are very frequently used to treat rotator cuff and shoulder labrum injuries. Many researchers have observed small areas of osteolysis after treating pathological conditions of the shoulder using bioabsorbable anchors. Biological and mechanical theories have been put forward to account for the osteolysis caused by these materials. The case of a patient who was simultaneously treated for a rotator cuff lesion using the double-row technique and a Bankart lesion using bioabsorbable PLLA anchors and Fiber Wire®, and developed extensive osteolysis of the anatomical neck of the humerus, is described. Given that an anchor was used in the glenoid, and this did not present osteolysis, the hypothesis that mechanical factors are important in the etiology of this complication is raised.
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La inestabilidad del hombro se define como una translación glenohumeral excesiva en una o varias direcciones y que se manifiestan por episodios sintomáticos de luxaciones o de subluxaciones más o menos dolorosas. A pesar del desarrollo de las técnicas artroscópicas, la cirugía a cielo abierto de la inestabilidad del hombro conserva muchas indicaciones y sigue siendo aún la técnica de referencia debido a sus resultados validados y duraderos. Una exploración física rigurosa y unas pruebas de imagen preoperatorias completas son fundamentales para identificar las lesiones capsuloligamentarias y/o de las estructuras óseas responsables, así como para establecer la indicación quirúrgica. En la inestabilidad anterior del hombro, la vía de acceso deltopectoral es común a todas las técnicas. Se deben diferenciar dos tipos de acceso quirúrgico, una reparación «anatómica» con procedimientos capsuloligamentarios o una reparación «no anatómica» con procedimientos óseos. El tope óseo anterior aún es en la actualidad la técnica de referencia en el tratamiento de estos hombros inestables. La inestabilidad posterior del hombro es mucho menos frecuente. Las técnicas quirúrgicas requieren también procedimientos capsuloligamentarios y óseos, comparables a los de su variante anterior.
Chapter
Suture anchors may be utilized for various applications in surgery, wherever soft tissue needs to be attached to bone. They represent the junction between bone and suture material, serving as anchors to the suture material which is used to tie soft tissue to bone. Even though suture anchors may also be used for exotic applications such as bladder suspension procedures, the main field of application is the upper extremity, chiefly the shoulder. Especially in arthroscopic surgery, suture anchors are of great value in the reconstruction of rotator cuffs, labrum defects or for tenodesis of the biceps tendon.
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Die Entwicklung rekonstruktiver Verfahren war ein Meilenstein in der Schulterarthroskopie. Manche arthroskopischen Stabilisierungsoperationen haben nach euphorischem Beginn die Erwartungen enttäuscht. Allerdings war die Fehleranalyse der Rückschläge unentbehrlich, um die Problembereiche des arthroskopischen Vorgehens erkennen zu können.
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This study evaluated the clinical effectiveness of a poly-L-lactic acid biodegradable suture anchor for arthroscopic Bankart reconstruction with a prospective multicenter study. Inclusion criteria were one or more episodes of traumatic dislocation or multiple post-traumatic subluxations as a manifestation of unidirectional anterior instability. Exclusion criteria were significant glenoid bone deficiency, large Hill-Sachs lesions, rotator cuff tears, multidirectional instability, posterior labrum tears, or biceps ruptures. Fifty-seven patients were followed up for a mean of 24 months. Postoperative apprehension tests were negative in all but two. Motion improved from 155degrees preoperatively to a mean of 175degrees postoperatively. Four patients had postoperative instability symptoms (two dislocators and two with subluxations). Postoperative radiographs demonstrated no lytic or resorptive bone changes from the suture anchors. The mean postoperative Rowe score was 93. The biodegradable suture anchor achieved good clinical results when used for arthroscopic Bankart reconstruction with no material-related adverse events.
Article
The used of absorbable implants in shoulder surgery is extensive. Both absorbable and non-absorbable implants appear to render good clinical results. However, there are reports of both early and late bony reactions, such as the formation of cysts at the site of implantation, especially after the use of polylactic- or polylevolactic acid polymer implants. Long-term radiographic studies have revealed that the formation of cysts is not as frequent after using polyglyconic acid co-polymer implants. In spite of good early clinical results, it is possible that the surgeon will have to handle inferior bone tissue in the anterior gleniod if revision surgery is required. Due to the frequent formation of radiographically visible cysts, even after seven to eight years, the authors do not recommend the use of polylactic- or polylevolactic acid polymer implants today. In the future, major efforts should be made to develop new polymers with osteoinductive/osteoconductive properties. However, the introduction of new polymers should also include long-term radiographic and clinical assessments in order to detect early and late failures that could be related to the design of the implants or their chemical composition.
Article
With the increasing use of bioabsorbable implants in a variety of clinical conditions, potential advantages in select spinal applications are now being realized. Newer polymers with biomechanical properties relevant to the requirements of specific spinal implants and resorption rates approapriate for specific spinal applications are being developed. These new materials offer the necessary biomechanical stability of conventional spinal implants without the sequelae associated with metallic implants such as long-term loosening, implant migration, and imaging inferference. At this time, the majority of clinical applications for these new polymers have involved tension band plating in the lumbar and anterior cervical spine, anterior spinal interbody reconstruction, posterior bone graft containment, and bone graft harvest site reconstruction.
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Bioabsorbable implants are frequently used in the treatment of rotator cuff and shoulder labrum injuries. Many authors have observed small areas of osteolysis after repair of shoulder abnormalities with absorbable anchors. Biological and mechanic theories are put forward to account for the osteolysis caused by these materials. We present a case of a patient who was simultaneously treated for a rotator cuff lesion with the double-row technique and a Bankart lesion with bioabsorbable PLLA anchors, and developed extensive osteolysis of the anatomic neck of the humerus. Because no lysis appeared in the glenoid around the other PLLA implant, we hypothesized that mechanical factors are important in the etiology of this complication.
Article
The use of suture anchors in shoulder surgery has facilitated the rapid advancement of arthroscopic rotator cuff repair techniques. Innumerable anchor types have been developed which allow stronger, rapid, more effective arthroscopic rotator cuff repairs. Abundant research has been performed to maximize the efficacy of suture anchors in arthroscopic rotator cuff repair. This article reviews the literature regarding implant designs, technical considerations, clinical results, and complications of suture anchors in the arthroscopic treatment of rotator cuff tears.
Article
Object In this pilot study the authors assessed the efficacy of bioabsorbable interbody spacers in the treatment of cervical degenerative disease. Metallic cages or interbody spacers have been widely used in the treatment of degenerative and traumatic cervical disease. Bioabsorbable technology has been used to develop a resorbable cage that can eliminate the complications and drawbacks seen with the use of traditional metallic implants. In general clinical practice bioabsorbable implants have shown the ability to degrade safely while demonstrating optimal imaging characteristics as a result of their radiolucency, and these devices eliminate stress shielding by their gradual dissolution. Methods This study is a retrospective evaluation of charts and x-ray films obtained in the first eight patients who underwent an anterior cervical decompression and fusion procedure with placement of a bioabsorbable interbody spacer and anterior cervical plate. All patients were treated in one surgeon's practice and had a minimum follow-up period of at least 6 months. At a follow-up interval of approximately 7 months, five patients exhibited an excellent result and three had a good result; no patient was noted to have a satisfactory or poor outcome according to the Odom criteria at their most recent follow-up visit. Seventeen (94%) of 18 grafted levels appeared to be solidly fused. One patient experienced a perisurgical complication consisting of a symptomatic hematoma, which was successfully drained. Conclusions Bioabsorbable interbody spacers appear to be a safe and effective interbody implant in terms of clinical outcome and radiographically confirmed healing.
Article
Instability of the shoulder remains a common problem in active individuals, and expectations for successful outcomes are high. Knowledge gained from the laboratory, from clinical observations, and from improved imaging modalities has allowed a better understanding of the natural history of instability, in turn providing a more rational basis for the development of minimally-invasive techniques for shoulder stabilization. Although open reconstruction is still regarded as the gold standard against which recent innovations must be judged, long-term outcome studies have revealed a significant risk of complications, including stiffness, nerve injury, and degenerative joint disease, in spite of relatively low recurrence rates.
Article
Aim Is arthroscopic revision of shoulder instabilities using suture anchors a viable alternative treatment to open revision surgery? Successful surgical stabilization of the shoulder is still a challenging problem. Many, mostly arthroscopic treatments using suture anchors are established for the initial surgery. In the literature, recurrence rates up to 49% are reported. Until now, the gold standard for these difficult recurrence cases was open revision surgery. Materials and methods From 2001 to 2007, 21 patients were retrospectively examined after arthroscopic revision surgery of the shoulder using suture anchors. The mean follow-up was 2.8 years (6 months to 6.2 years). Mean age at surgery was 27.8 years (17 to 34 years). An MRI of the shoulder was used preoperatively for diagnosis in all patients. All patients were clinically followed up, including a physical examination and MRI. Furthermore, the Diabilities oft the Arm, Shoulder and Hand (DASH), American Shoulder and Elbow Surgeons Standardized Assessment Form (ASES), and modified Constant Murley Score (CMS) were obtained. The MRI results were evaluated by an independent radiologist. Results A statistically significant difference between pre- and postoperative stability was found. There was no statistically significant correlation between the number of dislocations, the time interval between dislocation and stabilization surgery, and clinical outcome. The MRI showed good reconstruction of the labrum. The CMS rose from 72 preoperatively to 90 postoperatively, the ASES score from 59 to 88. The DASH score decreased from 42 to 9. There were no further dislocations until follow-up in this group. In a questionnaire, all patients would have surgery again. Conclusion The clinical outcome of the selected group at follow-up after arthroscopic revision surgery of the shoulder is equal to results published in the literature after open revision surgery. The procedure is in our view a viable alternative to open surgery by using an appropriate arthroscopic technique.
Article
Conventionally, radiography studies revealed prolonged glenoidal drill hole visibilities with an unclear influence to the clinical outcome after arthroscopic Bankart repair using Poly-Laevo-Lactic-Acid (PLLA) anchors. The primary aim of the present study was the separated assessment of drill hole consolidation (DHC) and the concomitant osseous reaction (OR) of the glenoidal bio-degradation process in new specific magnetic resonance grading systems. In accordance with the specific DHC and the OR graduation, the clinical relevance was the secondary focus. Twenty-eight patients with arthroscopic Bankart repair using knotless PLLA anchors were prospectively followed and analyzed using a clinical scoring system (3, 6, 15 and 32 months). The T2-weighted OR and T1-weighted DHC were assessed using specific magnetic resonance imaging grading protocols (15 and 32 months). Longitudinal assessments revealed successive clinical status improvements over time (32 months: Rowe 95.7 ± 3.8; Walch-Duplay 93.8 ± 6.6; Constant 93.9 ± 4.5; ASES 93.8 ± 6.9; DASH 28.6 ± 7.2; NAS(pain) 1.1 ± 1.3; NAS(function) 1.3 ± 1.4). The initial OR level regressed over the 15-32 month period while the DHC showed significant drill hole reductions (P < 0.05). The inferior glenoid revealed a significantly increased bio-degradation capacity (P < 0.05) with drill hole enlargements in 14.3%. Neither the OR nor the drill hole enlargements influenced the clinical status. In no case were clinical or radiologic signs for a foreign body reaction. Knotless bio-anchors provide secure glenoidal fixation for Bankart repair without any specific clinical or MR evidence of an inflammatory response. The clinical status remained unaffected by the bio-degradation process. IV.
Article
The development of the suture anchor has played a pivotal role in the transition from open to arthroscopic techniques of the shoulder. Various suture anchors have been manufactured that help facilitate the ability to create a soft tissue to bone repair. Because of reported complications of loosening, migration, and chondral injury with metallic anchors, bioabsorbable anchors have become increasingly used among orthopaedic surgeons. In this review, the authors sought to evaluate complications associated with bioabsorbable anchors in or about the shoulder and understand these in the context of the total number of bioabsorbable anchors placed. In 2008, 10 bioabsorbable anchor-related complications were reported to the US Food and Drug Administration. The reported literature complications of bioabsorbable anchors implanted about the shoulder include glenoid osteolysis, synovitis, and chondrolysis. These potential complications should be kept in mind when forming a differential diagnosis in a patient in whom a bioabsorbable anchor has been previously used. These literature reports, which amount to but a fraction of the total bioabsorbable anchors implanted in the shoulder on a yearly basis, underscore the relative safety and successful clinical results with use of bioabsorbable suture anchors. Product development continues with newer composites such as PEEK (polyetheretherketone) and calcium ceramics (tricalcium phosphate) in an effort to hypothetically create a mechanically stable construct with and improve biocompatibility of the implant. Bioabsorbable anchors remain a safe, reproducible, and consistent implant to secure soft tissue to bone in and about the shoulder. Meticulous insertion technique must be followed in using bioabsorbable anchors and may obviate many of the reported complications found in the literature. The purpose of this review is to provide an overview of the existing literature as it relates to the rare complications seen with use of bioabsorbable suture anchors in the shoulder.
Article
Bioabsorbable internal fixation has been clinically available for nearly 20 years and has been used for hard tissue and/or soft tissue fixation from the head to toe. During this time, there has been a rapid evolution in bioabsorbable polymers as well as in the implants and their clinical applications. There is a plethora of bioabsorbable polymers now available for clinical use, and although all are related chemically, seemingly small changes in formulation can have a dramatic effect on their biomechanical and physiological properties. This article summarizes much of the relevant scientific, technical, and clinical literature in a simple, straightforward manner to help surgeons better understand and appreciate the nuances of bioabsorbable fixation. This up-to-date review should also help researchers establish a baseline of knowledge that can provide a platform for further developments in this exciting field.
Article
The purpose of this study was to compare the clinical outcome of arthroscopic rotator cuff repair with metal and biodegradable suture anchors. Arthroscopic rotator cuff repair was performed in 110 patients with a full-thickness rotator cuff tear. They were divided into 2 groups of 55 patients each, according to suture anchors used: metal anchors in group 1 and biodegradable anchors in group 2. Results were evaluated by use of the Disabilities of the Arm, Shoulder and Hand (DASH) and Work-DASH self-administered questionnaires, as well as the Constant score normalized for age and sex. On analyzing the results at 2 years' follow-up, we considered the following independent variables: baseline scores; age; sex; arm dominance; location, shape, and retraction of cuff tear; fatty degeneration; treatment of biceps tendon; rotator cuff repair technique (anchors or anchors and side to side); and number of anchors. Univariate and multivariate statistical analyses were performed to determine which variables were independently associated with the outcome. Significance was set at P < .05. Of the patients, 9 (8.2%) were lost to follow-up. Comparison between groups did not show significant differences for each variable considered. Overall, according to the results, the mean DASH scores were 17.6 +/- 17.2 points in group 1 and 22.8 +/- 19.9 points in group 2; the mean Work-DASH scores were 24.9 +/- 28.1 points and 22.5 +/- 24.1 points, respectively; and the mean Constant scores were 104 +/- 20.5 points and 98.6 +/- 14.3 points, respectively. Differences between groups 1 and 2 were not significant. Univariate and multivariate analysis showed that only baseline score, age, tear location, and fatty degeneration significantly and independently influenced the outcome. At a short-term follow-up, differences between arthroscopic repair of full-thickness rotator cuff tears with metal and biodegradable suture anchors were not significant. Level I, high-quality randomized controlled trial with no statistically significant differences but narrow confidence intervals.
Article
The purpose of this study was to compare the clinical outcome of arthroscopic treatment of shoulder instability with metal and biodegradable suture anchors. Arthroscopic stabilization was performed in 78 patients with recurrent traumatic anterior shoulder instability. They were divided into 2 groups of 39 patients each, according to suture anchors used: metal anchors in group 1, and biodegradable anchors in group 2. Results were evaluated by use of the Disabilities of the Arm, Shoulder and Hand (DASH) self-administered questionnaire; Rowe score; Constant score normalized for age and gender, and recurrence of dislocation. On analyzing the results at a 2-year follow-up, we considered the following independent variables: age; gender; arm dominance; duration of symptoms, age at first dislocation, number of dislocations, type of work; type of sport; sports activity level; lesion of the anterior labrum and anterior-inferior gleno-humeral ligament; SLAP lesion, and number of suture anchors. Comparison between groups did not show significant differences for each variable considered. Overall, according to the results, median DASH scores were 4.5 points (range 0-27) in group 1 and 7 points (range 0-25) in group 2 (n.s.); median Rowe scores were 100 points (range 60-100) and 100 points (range 25-100), respectively (n.s.); and median Constant scores were 98 points (range 81-107) and 98 points (range 87-121), respectively (n.s.). Recurrence was observed in 1 patient (2.8%) in group 1 and in 2 patients (5.9%) in group 2. Overall recurrence rate was 4.3%. Univariate and multivariate analysis showed that age, duration of symptoms, number of dislocations, type of work, and type of sports significantly and independently influenced the outcomes. Differences between groups 1 and 2 were not significant. At a short-term follow-up, differences between arthroscopic shoulder stabilization with metal and biodegradable suture anchors were not statistically significant. Clinical relevance of the study is that there is no difference in the use of metal or biodegradable suture anchors for the arthroscopic treatment of shoulder instability.
Article
Recent studies have shown that techniques for arthroscopic Bankart reconstruction using suture anchors or tacks can equal the results after an open procedure in the treatment of posttraumatic, recurrent, unidirectional shoulder instability. Which kind of technique and which implants to be used still need further study. The aim of this study was to compare the clinical and radiographic results after arthroscopic Bankart reconstruction using 2 different types of absorbable implants. Randomized controlled trial; Level of evidence, 1. A randomized series of 40 patients who had recurrent shoulder instability underwent reconstruction involving either polygluconate-B polymer or self-reinforced poly-L-lactic acid polymer tack implants. The patients underwent radiographic and clinical assessments preoperatively and at 7 years. Blood levels of C-reactive protein were analyzed preoperatively and postoperatively. The radiographic visibility of the drill holes was significantly (P = .0001) greater in the poly-L-lactic acid polymer group than in the polygluconate-B polymer group. The failure rate in terms of stability was 5 of 36 (14%) after 7 years and, as previously reported by Magnusson et al, 2 of 40 (5%) after 2 years. Analyses preoperatively and postoperatively of C-reactive protein revealed no significant difference between the groups. No significant differences were found between the groups in terms of strength in abduction, range of motion, and Rowe or Constant scores. Seven years after Bankart repair using either implant, the overall clinical results were satisfactory. The visibility of the drill holes was significantly greater after using poly-L-lactic acid polymer implants.
Article
Absorbable suture anchors are widely used in arthroscopic shoulder reconstruction procedures and provide a good solution for stabilization in athletes. In our practice we identified a group of 3 patients who had participated in contact sports and in whom traumatic instability developed. Subluxation of the shoulder followed repair by use of absorbable suture anchors. Each patient had a new injury characterized by a glenoid rim fracture that was not amenable to further arthroscopic reconstruction and was revised by use of a modified Latarjet procedure. All patients successfully returned to contact sports. We conclude that resorption defects resulting from the use of absorbable anchors contribute to an increased risk of rim fracture.
Article
Bioresorbable implants for musculoskeletal injuries involving bone and ligaments in adults might have significant advantages compared to the conventionally used non-resorbable metal implants because they lead to a gradual transfer of the mechanical load from the implant to the healing bone and do not require a secondary removal operation. Tissue reactions may present a problem and bioresorbable screws are mechanically not as strong as their metal counterparts. To compare bioresorbable implants to non-resorbable implants with respect to functional outcome, wound infections, other complications and reoperation rate,in the fixation of bone fractures or re-attachment of soft tissue to bone. We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (March 2004), the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 1, 2004), MEDLINE (1966 to February 2004), EMBASE (1988 to February 2004), BL Inside (to February 2004), SIGLE (to February 2004), the metaRegister of Controlled Trials at http//:controlled-trials.com/, and reference lists of articles. Randomised controlled trials (RCTs) and quasi-randomised trials, comparing bioresorbable osteosynthesis with metal osteosynthesis (including titanium and stainless steel implants) were included. Review authors independently assessed trial quality and extracted data. Data were pooled where relevant and possible. Sub-analyses for specific type of fractures and for specific type of tissue reactions were performed. Requests for more information were sent to trialists. No significant difference between the bioresorbable and other implants could be demonstrated with respect to functional outcome, infections and other complications. Reoperation rates were lower in some of the groups of people treated with bioresorbable implants. In a selected group of compliant patients with simple fractures, the use of bioresorbable fixation devices might be advantageous.
Article
Although there would seem to be a logical relationship between radiolucency around the suture anchor and clinical result in Bankart repair, the correlation has not been demonstrated so far. Knotless suture anchor is a viable alternative for arthroscopic Bankart repair, but postoperative radiologic findings of radiolucency around anchors are correlated with poor clinical results. Case series; Level of evidence, 4. Sixty-nine consecutive patients with Bankart lesions were treated with arthroscopic reconstruction using knotless metal suture anchors. The mean follow-up was 40 months. Clinical and radiologic analysis was performed retrospectively. A new concept of perianchor radiolucency was introduced and, according to this radiologic finding, patients were divided into 2 subgroups: the perianchor radiolucency group and those who did not reveal perianchor radiolucency. The perianchor radiolucency group was further subdivided by shape and location. "Root type" was defined as a radiolucent halo at the root of the anchor, and perianchor radiolucency without any root halo was named "branch type." Location of perianchor radiolucency was described as above or below the equator of the glenoid. After operation, the mean Rowe score increased to 93.8 from 43.1, and computed tomography arthrogram showed a 97% healing rate. Reoperations were performed due to 1 case of redislocation and 2 cases of anchor arthropathy. All these reoperated cases revealed perianchor radiolucency before reoperation. Other than reoperated cases, 2 patients showed apprehension at final evaluation. The perianchor radiolucency group had a significantly lower Rowe scores than the group that showed no perianchor radiolucency. Some of the patients in the perianchor radiolucency group had peculiar radiologic findings frequently associated with complications. The radiologic findings that consisted of root-type perianchor radiolucency located below the equator of the glenoid was termed the "ominous sign." Osteophytes of the humeral head together with the ominous sign is considered a warning sign of forthcoming progression of anchor arthropathy, and the authors suggest early surgical intervention with these findings. After Bankart repair using knotless suture anchor, the ominous sign might be an important warning sign for possible forthcoming complications including redislocation, anchor arthropathy, and residual instability.
Article
Anterior cervical diskectomy and fusion is a widely accepted treatment for anterior management of degenerative or traumatic instability of the cervical spine. To reduce or eliminate complications such as implant migration and failure, imaging degradation, and fusion stress shielding that are occasionally associated with spinal instrumentation, attention has been given to the use of bioresorbable anterior cervical plating devices. This paper is a preliminary report of a retrospective series in which a resorbable mesh and screw system (OS Reconstructive Mesh, MacroPore Biosurgery Inc, San Diego, Calif) was used for graft containment in single-level anterior cervical diskectomy and fusion. A review of patient charts and imaging studies was conducted to determine functional outcome, fusion success, and potential soft-tissue reaction to implant resorption. Nine patients with a diagnosis of cervical degenerative disk disease or traumatic disk disruption were treated between October 2001 and March 2002. Follow-up averaged 206 days. Eight patients were found to have an excellent result, one patient had a good result, and no patients had a satisfactory or poor result. At the time of follow-up, 77% of patients (7/9) were found to have a radiographically solid fusion. The two patients without a solid fusion were only on average 8 months out from their fusion procedure and manifested no symptoms related to fusion nonhealing. No significant soft-tissue reaction was noted clinically or radiographically in any of the patients. The results of this preliminary study indicate that bioresorbable anterior cervical plating for single-level anterior cervical diskectomy and fusion is both safe and effective.
Article
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Biodegradable rods of polyglycolide or lactide-glycolide copolymer were used in the internal fixation of a variety of fractures and osteotomies in 516 patients. A clinically manifest foreign-body reaction occurred in 41 patients (7.9%), producing a fluctuant swelling at the implantation site after an average of 12 weeks. Spontaneous sinus formation or surgical drainage yielded a sterile exudate containing liquid remnants of the degrading implants. After prompt drainage this discharge subsided within three weeks. Histological examination showed a typical nonspecific foreign-body reaction with abundant giant cells both in patients with the reaction and in some patients with an uneventful clinical course. The factors determining the nature of the reaction were probably related to the local capacity of the tissues to clear the polymeric debris. The reactions did not influence the clinical or radiographic results, but recognition of the incidence and the features of the reaction is necessary in view of the increasing use of such implants.
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Surgical reconstructions of anterior-inferior shoulder instabilities and rotator cuff injuries require secure fixation of soft tissue to bone. Sutures are inserted directly through transosseous tunnels in current techniques, which are surgically complex and not always adequate for fixation strength. Using fresh-frozen cadaveric human specimens, our objectives were 1) to compare immediate pull-out strength of two versions of polyacetal suture anchors (wedge and rod) with conventional suture-only attachment techniques in Bankart lesion and rotator cuff repairs, and 2) to compare pull-out strength of the two polyacetal suture anchors with a metallic suture anchor. Our results indicate no significant differences in fixation strength of Bankart lesions or rotator cuff repairs using sutures only, or using wedge or rod polyacetal suture anchors (P = 0.70). Pull-out force did not differ significantly (P = 0.37) between the two polyacetal anchors. Polyacetal anchors exhibited higher pull-out forces than metallic anchors when inserted into metaphyseal regions of the tibia and significantly higher pull-out forces (P < 0.001) when inserted into metaphyseal regions with thicker cortical walls. Our results indicate that both polyacetal suture anchors provide adequate immediate fixation for soft tissue repairs in the human shoulder.
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The science of biodegradable materials is most often associated with problems of environmental control. The need to avoid accumulation of permanent ecological litter is obvious and methods to do so will not be considered in this discussion. Rather, the emphasis will be on polymers with the potential for degradation within the living organism. More specifically, polymers which display structural integrity and, as a consequence, mechanical utility, will be considered while polymeric drugs or carriers which function in solution, such as polyvinyl pyrollidone and dex-tran, both reported as useful blood extenders, will not.
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This article reviews an arthroscopic technique used to repair small- and medium-sized rotator cuff tears using a retrievable screw-in suture anchor and permanent braided sutures. The cuff is shaved, the bone is prepared arthroscopically, and a subacromial decompression is performed. After implanting the anchors, the sutures are passed through the cuff using Shuttle Relay suture passers and a suture punch. To complete the repair, the sutures are tied using a knot-pusher.
Article
Bioabsorbable implants offer several advantages over metal implants when used in fracture fixation including gradual stress transfer to the healing bone and the elimination of secondary procedures for implant removal. However, the inferior mechanical properties of the polymeric implants have limited their widespread use. Research models to define these properties have been difficult to standardize secondary to the numerous factors governing the in vivo behavior of polymeric implants. Chemical composition, manufacturing processes, as well as physical and environmental factors influence the biomechanical characteristics when these implants are used in fracture fixation. The biomechanical properties change over time as the implants are degraded, influencing the clinical use of these implants. (C) Williams & Wilkins 1998. All Rights Reserved.
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Biodegradable rods made of polyglycolide (Dexon, Biofix) or lactide-glycolide copolymer (Vicryl) have been used for the past 5 years for internal fixation of a variety of fractures and osteotomies (Böstman et al. 1989, 1990b). Experience from using such rods for fixation of intraarticular osteochondral lesions seems to be less extensive. We report a case of severe synovial reaction to biodegradable rods used for fixation of osteochondritis dissecans of the knee and discuss possible reasons for the increased risk of foreign-body reactions when these rods are used intraarticularly.
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We report two cases of severe aseptic synovitis of the knee 8 and 13 weeks after biodegradable internal fixation (Biofix rods) of a fracture of the intercondylar eminence. Both knees were treated by surgical revision and synovectomy. Histologic examination revealed a severe foreign-body type of reactive synovitis in the absence of infection. It is not advisable to use Biofix intraarticularly.
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Seventy-eight chevron osteotomies augmented by internal fixation with self-reinforced polyglycolide pins, 2 mm in diameter, were performed in 60 patients suffering from a painful hallux valgus. The mean metatarsophalangeal angle was 31 degrees, and there was a metatarsus primus varus varying from 10 degrees to 20 degrees. The average follow-up time was 14 (range, 12 to 31) months. No postoperative redisplacement or disturbance of healing of the osteotomy was observed, but recurrence of hallux valgus occurred in 8 feet (10%), each initially with a moderate to severe hallux valgus. Some pain at the first metatarsophalangeal joint during physical activity remained in 12 feet (15%). There was a mean shortening of 2.5 mm of the first metatarsal bone, and the most significant shortening was associated with pain in the forefoot. The metatarsophalangeal joint motion was not decreased. The subjective overall result was excellent or good in 75% of the patients. Because of the biodegradability of the implants used, no secondary procedures to remove the implants were necessary.
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Bankart capsulorraphy for recurrent shoulder instability produces predictable results. Time-consuming, technically demanding details of the procedure, however, discourage its use. A simplified technique and new instrumentation solving these limitations was used in 69 procedures, all performed by the same surgeon. Seventy-eight percent of these procedures were reviewed independently at a minimum of 2 years followup: 77% were asymptomatic, 12% had minimal symptoms, and 11% had residual problems. Instability recurred in six patients and was associated with a significant traumatic event in five. Thus, the inside-out Bankart modifications were effective.
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Many different materials have been used by orthopedic and maxillofacial surgeons to repair bony deficiencies. This review is limited to those materials that have been shown to be tissue-tolerant and biodegradable, and to include certain synthetic polymers and ceramics. There are many possible applications for these agents. Special terms and concepts are germane to an understanding of polymers and ceramics.
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Screws and staples are used frequently in the surgical treatment of glenohumeral joint problems. We analyzed a series of thirty-seven patients with complications related to the use of these implants. Twenty-one patients had problems related to the use of screws for affixing a transferred coracoid process to the glenoid. Sixteen patients had problems related to the use of staples: ten had undergone capsulorrhaphy, four had had advancement of the subscapularis, and two had had repair of a rotator cuff tear. The complaints at examination were shoulder pain (thirty-six patients), decreased glenohumeral motion (nineteen patients), crepitus with glenohumeral motion (sixteen patients), and radiating paresthesias (four patients). The time between placement of the implant and the onset of symptoms ranged from four weeks to ten years. The screws or staples had been incorrectly placed in ten patients, had migrated or loosened in twenty-four, and had fractured in three. Thirty-four patients required a second surgical procedure specifically for removal of the implant. At operation fourteen patients (41 per cent) were noted to have sustained a significant injury to the articular surface of the glenoid or humerus. The results in this group of patients indicated that screws and staples can produce complications that require reoperation and are capable of causing a permanent loss of joint function. Adequate surgical exposure and careful placement of the implant appear to be essential when these devices are used about the glenohumeral joint.
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Surgical clips have gained wide spread acceptance because of speed and utility in operative fields with difficult exposure. Certain disadvantages make metallic clips less than optimal for many operative situations. Such problems include difficulty in loading metallic clips into the applier, clips falling from the applier in the transfer from nurse to surgeon or while the surgeon is positioning the clip for application and clips coming off a vessel to which it was applied. The interference which metallic clips produce in computerized tomography and their permanency must be added as factors to be evaluated in comparison with absorbable clips.
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Twenty-six consecutive cadet athletes sustained an acute, initial anterior shoulder dislocation. All dislocations required a manual reduction for initial treatment. Arthroscopy was performed within 10 days in all patients. The Beach chair position and interscalene anesthesia were used in each case. At arthroscopy, 25 patients had an avulsion of the anterior-inferior capsulolabral complex (Bankart lesion) from the glenoid rim. One patient had a lateral detachment of the inferior glenohumeral ligament from the humeral neck. Twenty-three patients had a Hill-Sachs lesion and 3 SLAP tears were noted. All Bankart lesions were repaired with a cannulated bioabsorbable fixation device. Nineteen patients, over 1 year postoperative, are the subject of this preliminary report. The average age was 19.5 years (range, 17 to 23 years). Follow-up averaged 19 months (range, 12 to 24 months). The average loss of external rotation was 3 degrees. There have been no recurrent dislocations and 1 patient has had a single episode of resubluxation. Using the Rowe point score, 16 patients were rated excellent, 2 good, and 1 fair. All of the athletes in this study have returned to preinjury performance status. Acute stabilization of initial anterior shoulder dislocations appears to be an effective treatment option in young athletes known to have high recurrence rates with nonoperative treatment. This particular technique has been safe with little morbidity.
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Bioabsorbable ultra high strength poly (L-lactide) rods, which were developed for internal fixation of fractures, were fabricated using a drawing technique. These rods were implanted in the subcutaneous tissue and in the medullary cavity of rabbits to investigate tissue reactions to poly (L-lactide) and to study their degradation process. After 18 months, histiocytes were found, and their phagocytic activity continued for as long as 42 months, with maximum activity observed between 24 and 36 months after implantation. At 62 months after intramedullary implantation, the materials had been absorbed almost completely and were replaced by bone marrow cells, with only a small amount of residual tissue reaction. At 69 months after subcutaneous implantation, the materials had been absorbed completely without any scar formation. During degradation, no foreign body giant cells were found and osteolytic expansion caused by liquid degradable materials was not seen.
Article
Suture anchors are playing an increasingly important role in attaching tendons or ligaments to bone. Anchors are usually made of metallic or other nonbioabsorbable materials. The development of an absorbable suture anchor would provide a valuable tool for the surgeon; this characteristic would minimize the problems of anchor loosening, migration, interference with imaging studies, and the potential requirement for later implant removal. This study evaluated the in vivo histological response over time of the first generation Arthrex Expanding Suture Plug (ESP) (Arthrex Inc, Naples, FL). Suture anchors threaded with nonabsorbable No. 2 braided polyester sutures were implanted into ram femurs and removed at various intervals over a period of 12 weeks. After preparation, histological study showed a gradual healing response in the bone tract. There was no evidence of an inflammatory infiltrate or foreign-body reaction during the 12 weeks of implantation. A normal bone callus appeared at the insertion tunnel site consistent with a fracture-healing response. Later, a fibrous membrane appeared at the junction of the implant and the bone tunnel. Over the 12 week interval, there was a decrease in osteoblastic activity and the appearance of cavernous vascular spaces in the superficial portions of the membrane near the periosteum. The ESP anchor composed of poly-L-lactic acid was well tolerated in the in vivo setting. Throughout the study, no substantial acute, chronic, or foreign-body reaction was observed. These observations are consistent with the expected in vivo behavior of poly-L-lactic acid. There is no reason to believe that the ESP composed of poly-L-lactic acid should cause a foreign body reaction.
Article
Endoscopic meniscus repair using the T-Fix suture device (Acufex Microsurgical, Inc, Mansfield, MA) allows ease of suture placement for meniscus stability without the problems associated with ancillary incisions such as neurovascular compromise. It is ideal for the central posterior horn tears that are difficult using conventional techniques. Vertical tears, bucket handle tears, flap tears, and horizontal tears can be approached using a temporary "anchor stitch" to stabilize the meniscus before T-Fix repair. The basic method of repair and our approach to these different types of tears is presented.
Article
We evaluated three mechanical soft tissue fixation devices (SuperAnchor, Suretac, and the Instrument Makar [IM] Bioabsorbable Staple) in a cadaveric model by examining ultimate tensile failure and modes of failure in simulated Bankart repairs. We attempted to realistically evaluate the strengths of soft tissue reattachment procedures at the anterior glenoid under worst-case conditions--load to failure. Twenty fresh-frozen cadaveric shoulders were used in this investigation. Each of the three techniques was performed in each anterior glenoid rim at one of three locations: superior, middle, or inferior. The subscapularis muscle-tendon was harvested, used in the repair, and loaded to failure. The mean load at failure for the SuperAnchor was 217.32 N; for the IM Staple, 132.32 N; and for the Suretac, 122.37 N. A two-sample t-test demonstrated that the load at failure for the SuperAnchor was statistically greater (P < 0.001) when compared with the IM Staple and Suretac. There was no statistical difference between load at failure for the Suretac and the IM Staple. The most common failure mode for the Mitek was suture breakage (71%). Anchor pullout from bone was the most common failure mode for the IM Staple (75%) and Suretac (94%).
Article
One hundred and fifty-five patients who had a closed, displaced medial malleolar, bimalleolar, or trimalleolar fracture of the ankle were managed with medial malleolar fixation with use of either 4.0-millimeter orientruded polylactide screws (eighty-three patients, study group) or 4.0-millimeter stainless-steel screws (seventy-two patients, control group). All lateral malleolar fractures were stabilized with standard metallic implants. At an average of thirty-seven months (range, twenty-one to fifty-nine months), the radiographic and functional results in the two groups were equivalent. Differences between the two groups with regard to the rates of operative and postoperative complications were not statistically significant. Late spontaneous drainage of the hydrolyzed polylactide was not noted in any patient in the study group. The prevalence of late tenderness over the medial malleolar implant was lower in the patients in whom the fracture had been stabilized with polylactide screws. We conclude that polylactide screws are a safe and effective alternative to stainless-steel screws for the fixation of displaced medial malleolar fractures.
Article
Anterior shoulder dislocation in the young athlete may be difficult to treat and, without proper care, usually results in recurrent episodes of instability. By permitting direct visualization of all intraarticular pathology, the arthroscope assists in the diagnosis and helps to determine appropriate therapeutic interventions. Numerous techniques have been developed for arthroscopic reconstruction of unstable shoulders. These can be classified according to the type of fixation employed. The categories include metal devices such as staples or screws, absorbable devices, and suture-based methods, both anterior and transglenoid. An anterior suture anchor method using a new suture passing device known as a Shuttle Relay (Linvatec Corp, Largo, Fla), which allows the surgeon to incorporate non-absorbable mattress sutures in the repair, is described in detail.
Article
Suture anchors are increasingly used to secure tendons or ligaments to bone. These devices are applicable for arthroscopic shoulder stabilization and rotator cuff repair. This study reports the in vivo characteristics of four anchors, including one absorbable anchor composed of poly-L-lactic acid. Failure strength and method of failure were recorded for these anchors as a function of time. Samples of four anchors [Mitek G2, Zimmer Statak, Acufex TAG wedge, and the absorbable Arthrex expanding suture plug (ESP)] were implanted into ram femurs and harvested at intervals. Each bone-anchor-suture system was stressed to failure. The failure force and failure method was recorded. Mitek G2 and Statak suture anchors failed consistently at 30 pounds by suture breakage. They had no implantation difficulties. The TAG wedge exhibited suture pull-out and implant flipping at insertion. The TAG wedge failed by suture cut-out, anchor pull-out, and suture breakage. Its average failure strength was initially 16 pounds, but increased to 28 pounds at 2 weeks and reached the 30-pound level by 4 weeks. The ESP poly-L-lactic acid anchors experienced implantation breakage in 20% because of their greater length and composition. At pull-out testing, the ESP failed by suture cut-out, anchor pull-out, and suture breakage. Failure strength was initially 27 pounds, was 17 pounds at 2 weeks, and increased to 30 pounds by 6 weeks. The absorbable ESP does not have initial pull-out strength comparable with the Mitek and Statak suture anchors but does achieve this strength by 6 weeks.(ABSTRACT TRUNCATED AT 250 WORDS)
Article
This article presents a different arthroscopic approach to the diagnosis and treatment of anterior shoulder instability. Surgical technique, the postoperative regimen, and the results and pitfalls of surgery using suture anchors are discussed.
Article
Five commercially available suture anchor devices were tested to failure in human cadaveric proximal tibiae. A total of 198 trials were completed. Insertion was uncomplicated for all anchors, with the exception of the Acufex Rod TAG device, with five of 22 (23%) of these breaking upon insertion into thicker cortical bone. Overall, the anchors performed significantly (p < 0.05) better when placed in thicker cortical bone, further away from the joint surface, and when loaded in a direction parallel to the bone surface. The Mitek GII anchor failed (pulled out of bone) less often than the other anchors (19% vs. 46%). In loading perpendicular to the bone surface, the Mitek GII and Statak were the strongest (p < 0.05), with mean loads at failure of 82.5 and 90.2 N, respectively. The Acufex Rod TAG, Acufex Wedge TAG, and Mitek GI failed at 67.2, 65.5, and 49.4 N respectively.
Article
The use of metallic implants about the shoulder joint can be complicated by loosening, migration, and breakage of the implant. Bioabsorbable implants would be an ideal solution to this problem if their bioabsorption profile could be fine tuned to appropriately share stress with the healing tissues. The development of such an implant must satisfy four basic criteria: (1) The bioabsorbable implant must have adequate initial fixation strength to coapt the soft tissues to bone; (2) The implant's bioabsorption profile must enable it to retain satisfactory strength while the healing tissues are regaining mechanical integrity; (3) The implant must not bioabsorb too slowly or it will behave like its metal counterpart with breakage and migration; and (4) The implant must be made of materials that are completely safe: no toxicity, antigenicity, pyrogenicity, or carcinogenicity.
Article
A randomized, prospective multicenter comparison was done of a bioabsorbable interference screw (Bioscrew; Linvatec Corp, Largo, FL) made from poly L-lactic acid and a metal interference screw produced by the same company. Assignment was randomized by sealed envelopes. A total of 110 patients underwent arthroscopic patellar tendon autografts. A minimum 12 months follow-up is available on 85 patients (mean 19 months, range 12 to 33) including 42 with Bioscrews and 43 with metal screws. There were 56 male and 29 female patients. The average age was 29 years (16 to 50 years). Tourniquet times and associated surgical findings were similar for the two groups. Postoperative Tegner and Lysholm scores were not statistically different between the two groups. KT tests at 1 year showed an average 20-lb laxity of 1.8 mm for the Bioscrew and 1.2 mm for the metal screw groups. The average 1-year KT maximum manual side-to-side difference was 1.6 mm for Bioscrews and 1.6 mm for metal screws. A pivot shift was absent in 83% of Bioscrews and 90% of metal screws at follow-up. Six of 85 Bioscrews inserted (7%) broke on insertion (all were 7-mm diameter screws at the femoral site). No additional fixation was required in four cases. In two, the broken screw was replaced. No lytic bone changes or tunnel widening were found with any Bioscrew. One metal screw had tibial tunnel widening. No statistical difference was found between the Bioscrew and the metal screw groups. Short-term data support the conclusion that the Bioscrew is a reasonable alternative to metal interference screws.
Article
The authors present 3 cases of osteochondritis and 2 cases of osteochondral fracture of the knee. These cases were treated with a bioabsorbable ultra high strength poly (L-lactide) pin, which has the highest mechanical strength value of any nonfiber reinforced poly (L-lactide) reported previously. Three of the patients were male, and 2 were females; their ages ranged from 12 to 21 years. The followup period ranged from 2 years to 7 years 9 months (mean, 4.1 years). Two to 4 poly (L-lactide) pins with a diameter of 2 mm were used to fix the osteochondral fragments or the transplanted autogenous osteochondral grafts. In all cases, satisfactory bone union was obtained, and no inflammatory reaction was observed during the entire followup periods. The ranges of motion were normal, and there was no pain in any of the cases. It is concluded that the poly (L-lactide) pin is safe and useful in the repair of osteochondral fractures of the knee and in fixing grafted osteochondral fragments.
Article
We report results on the use of bioabsorbable pins and intramedullary rods made of high-molecular-weight polylactic acid in both experimental and clinical conditions. In the experimental study, bioabsorbable rods were implanted in rabbit femora. Histologic assessment on nondecalcified bone showed that resorption of the material began at 4 months after implantation and gradually fragmented over a period of 3 years. In 12 patients 13 metacarpophalangeal joints of the thumb were arthrodesed by using one bioabsorbable intramedullary rod with one or two oblique pins. All joints fused within 6 to 8 weeks. During that period there was no sign of inflammation, and there were no nonunions. Postoperative magnetic resonance imaging assessment was done in all rabbits and eight patients. This modality is a useful tool in postoperative evaluation of the position and shape of the rod but is not sufficiently sensitive to assess the presence of local inflammation and the rate of resorption of the rods.
Article
Because of the good initial fixation strength of interference screws used in anterior cruciate ligament reconstruction, metal interference screws have become the standard method for fixation of bone-patellar tendon-bone grafts. To avoid some of the complications with metal screws, a bioabsorbable interference screw was developed. Data on fixation strength in older human cadavers indicate a similar failure strength between bioabsorbable and metal screws. We studied the failure mechanisms, insertion torques, and fixation strengths of absorbable and metal interference screws in cadaveric knees from young and middle-aged donors. With identical gap and screw size, the mean insertion torque for the metal screws (mean, 1.5 N-m; SD, 0.8) was significantly higher than for the absorbable screws (mean, 0.3 N-m; SD, 0.19). The mean failure load for the metal screws (mean 640 N; SD, 201) was also significantly higher than for the absorbable screws (mean, 418 N; SD, 118).
Article
The importance of preserving meniscal tissue has become increasingly apparent as studies have demonstrated early arthritic changes in the knee. To increase the healing rate of complex tears, the use of a fascial sheath to encapsulate the exogenous clot around the tear has previously been proposed. This report describes the placement of a fascial sheath over a repaired meniscal tear using a T-fix anchor suture. With the increased use of fascial sheaths in combination with an exogenous blood clot, meniscal repair rates in complex tears can be increased.
Article
Symptomatic anterior glenohumeral instability secondary to a Bankart lesion may require surgical reconstruction and repair of labral pathology. In this report, a Bankart repair was performed using metallic suture anchors. An infection developed around the anchors necessitating their removal. To our knowledge, this is the first report of an infection associated with a suture anchor device.
Article
A retrospective review of the medical records and radiographs of 32 consecutive patients, totaling 52 extremities with chevron osteotomies for hallux valgus, was conducted to compare K wire fixation with absorbable (poly-p-dioxanone) pin fixation. Each group comprised 21 feet, with a mean clinical follow-up of 35.6 months (25.6-50.5 months) in the K wire group and 23.1 months (13.7-28.8 months) in the absorbable pin group. Demographics as well as final clinical follow-up scores (hallux-metatarsophalangeal-interphalangeal scale and visual analogue scores) were similar in both groups. Postoperative hallux valgus and intermetatarsal angles were similar in both groups. No complications, such as osteolysis for inflammatory sinus formation, occurred in the absorbable pin group. Two patients in the K wire group had a malunited osteotomy and two patients had a retained K wire at final follow-up. Our experience suggests that poly-p-dioxanone pins are at least as effective as K wires, and the previous reports of inflammatory sinus formation and osteolysis are not a significant concern in the fixation of chevron osteotomies for hallux valgus.
Article
Arthroscopically assisted repair of the anterior aspect of the labrum with use of a bioabsorbable tack was performed in fifty-two consecutive patients who had chronic anterior instability of the shoulder. The average age of the patients was twenty-eight years (range, sixteen to fifty years). The etiology of the instability was a traumatic injury in forty-nine patients; twenty-six of those injuries were sustained during participation in a contact sport. Fifty shoulders had a Bankart lesion. The patients were evaluated at an average of forty-two months (range, twenty-four to sixty months) after the procedure. Forty-one (79 per cent) of the patients were asymptomatic and were able to participate in sports without restriction. The repair was considered to have failed in eleven (21 per cent) of the patients. In four of them, the failure resulted from a single traumatic reinjury during participation in a contact sport, and three of these reinjuries were treated nonoperatively. The remaining seven failures occurred atraumatically. Eight patients had an open glenoid-based capsulorrhaphy as a consequence of recurrent instability. At the reoperation, no evidence of the tack was found in any patient. In seven patients, the Bankart lesion had completely healed, and the anteroinferior aspect of the capsule was patulous. Anterior stabilization of the shoulder with a bioabsorbable tack may be indicated for patients who have anterior instability but do not need a capsulorrhaphy or capsular imbrication to reduce the joint volume.
Article
The authors propose a new bioabsorbable fixation device to be applied to V-shaped transverse osteotomies of the head of the first metatarsal (Austin-chevron osteotomies) for hallux valgus surgery. Namely, a 3.3-mm. diameter cortical screw made of poly-L-lactic acid. This screw was applied in 30 patients with an average age of 44 years (range: 20 to 61). A total of 35 osteotomies was performed. The study refers to the period between 1992 and 1994 with a mean follow-up of 18 months (range: 12 to 36 months). The results of the study demonstrate good stability of the synthesis, with normal union (mean: 4 weeks), no adverse tissue reactions or osteolytic phenomena were noted. One patient developed avascular necrosis of the metatarsal head, which in the opinion of the authors, was not due to the device implanted. Over 90% of the patients were satisfied with both the aesthetic and functional results. The authors conclude that the poly-L-lactic acid cortical screw is a promising bioabsorbable fixation device for this corrective osteotomy in selected patients less than 50 years old, with good first metatarsal bone stock.
Article
In this prospective study, 40 consecutive patients identified as high risk for recurrent instability were managed by an arthroscopic Bankart repair using nonabsorbable sutures and anchors. The technique employed is an arthroscopic modification of the capsulolabral repair described by Jobe. One-and-one-half to 3 years postoperatively (average 30 months), 37 of the 40 patients (93%) remained stable. The average Bankart score was 90. Thirty-seven of the 40 patients returned to normal activities, including sports, by 6 months postoperatively. Twenty-nine of the 32 patients involved in athletic activities returned to their respective sports at the same or higher level. Three patients had discontinued sporting activities due to graduation but felt as though they could resume their activities at the same level. Three patients developed recurrent instability, all of whom required surgical restabilization. Arthroscopic Bankart Repair using suture anchor technique in a high demand population provided results superior to those previously reported with the suture punch technique in our patient population. The results may be equivalent to open reconstruction in this high-risk patient population.
Article
Twenty-one patients with unstable medial malleolar, bimalleolar, or trimalleolar ankle fractures underwent open reduction and internal fixation of the medial malleolus with 4.5-mm polyglycolide screws. All lateral malleolar fractures were internally fixed with standard metallic implants. Radiographic and clinical follow-up results were available on 16 of 21 patients. All fractures healed at an average of 3.4 months (range, 3–6 months), and there were no medial wound infections. Eight of 16 patients developed an inflammatory reaction to the biodegradable polyester at 3 to 4 months after implantation, including one who developed a sterile draining sinus tract. No surgical or nonsurgical treatment was required in those eight patients. We conclude that whereas polyester screws yield union rates and functional results similar to those of metallic screws in the treatment of medial malleolar fractures, the use of polyglycolide screws is associated with an unacceptable rate of inflammatory reactions.
Article
In a study to evaluate the preliminary results of endoscopic meniscus repair using the T-fix suture anchor (Acufex Microsurgical Inc, Mansfield, MA), 21 mensiscus repairs in 20 patients were prospectively followed-up for a minimum of 1 year. There were 11 medial and 10 lateral tears; 14 were in the peripheral third (zones 0-1) and 7 were in the central third (zone 2) of the meniscus. All patients had associated anterior cruciate ligament reconstructions. At follow-up, 4 patients were symptomatic, 3 of whom had tears that were complex and in zone 2. Radiographic follow-up showed that 3 patients had a mild progression Fairbank's change. One patient required removal of all sutures because of infection. Second-look arthroscopy on 4 cases revealed that 3 had healed and 1 had not healed. Meniscus healing can be accomplished with T-fix endoscopic technique if principals of meniscus repair are adhered to (i.e., blood supply, synovial rasping, stable fixation).
Article
The medial collateral ligaments of 18 New Zealand rabbits were surgically detached from bone. In one knee, the ligament was repaired using a biodegradable suture anchor composed of a co-polymer of lactic and glycolic acid. The contralateral medial collateral ligament was not repaired. Animals were sacrificed at 4, 8, and 12 weeks after the operation, and the knee that had the ligament repair was compared with the contralateral control knee. All knees were tested manually tested for stability to valgus stress and then prepared for histologic examination. Medial collateral ligaments repaired using the biodegradable suture anchor demonstrated stability to valgus stress and anatomic healing at the bone-tendon junction. Resorption of the implant was virtually complete by 12 weeks. All specimens demonstrated less inflammatory reaction to the suture anchor than to the attached Vicryl suture. This contrasts with the control group, which was grossly unstable and demonstrated scarring in this nonanatomic position. These results demonstrate efficacy of this particular material of biodegradable implant and justify further investigative efforts.