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Pain Reduction by Percutaneous Vertebroplasty with Calcium Phosphate in Traumatic Vertebral Fractures
Abstract
Background & Objectives: Vertebroplasty is a new and effective treatment for strengthening broken vertebra and reducing the pain arisen from osteoporotic fractures. This study was performed to determine the pain reduction effect of percutaneous vertebroplasty with calcium phosphate in traumatic vertebral fractures in patients attending to Laleh, Mehrad and Booali Hospitals in 2012. Materials & Methods: In this quasi-experimental study, 18 patients with traumatic fractures in Laleh, Mehrdad and Bu Ali hospitals were studied during the year 2012. The method of purposeful non-probability sampling was used and ethical issues were carefully considered. Pain intensity were determined and compared based on Visual Analog Scale in 3 phases; before and immediately after percutaneous surgery and vertebroplasty with calcium carbonate, and 6 months later. The data were analyzed using SPSS software and descriptive statistic method. Results: In this study, at first, the mean preoperative VAS was 8.2 that, subsequently, decreased to 1.68 and zero. Comparison of preoperative and postoperative pain severities demonstrated that 79.6% reduction was observed in the pain and later this amount was increased to 100%. Overly, there was not a relationship between changes in VAS and variables such as leakage in patients, age, calcium carbonate amount, gender and level of involvement. Conclusions: It may be concluded that percutaneous vertebroplasty with calcium phosphate is effective in patients with traumatic vertebral fractures. Choosing the right patient, precise needle placement with fluoroscopic guide, timely injection of cement and experience play key roles in the success of this method. Keywords: Percutaneous vertebroplasty, Traumatic vertebral fractures, Pain
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Vertebroplasty is commonly used to treat painful, osteoporotic vertebral compression fractures.
In this multicenter trial, we randomly assigned 131 patients who had one to three painful osteoporotic vertebral compression fractures to undergo either vertebroplasty or a simulated procedure without cement (control group). The primary outcomes were scores on the modified Roland-Morris Disability Questionnaire (RDQ) (on a scale of 0 to 23, with higher scores indicating greater disability) and patients' ratings of average pain intensity during the preceding 24 hours at 1 month (on a scale of 0 to 10, with higher scores indicating more severe pain). Patients were allowed to cross over to the other study group after 1 month.
All patients underwent the assigned intervention (68 vertebroplasties and 63 simulated procedures). The baseline characteristics were similar in the two groups. At 1 month, there was no significant difference between the vertebroplasty group and the control group in either the RDQ score (difference, 0.7; 95% confidence interval [CI], -1.3 to 2.8; P=0.49) or the pain rating (difference, 0.7; 95% CI, -0.3 to 1.7; P=0.19). Both groups had immediate improvement in disability and pain scores after the intervention. Although the two groups did not differ significantly on any secondary outcome measure at 1 month, there was a trend toward a higher rate of clinically meaningful improvement in pain (a 30% decrease from baseline) in the vertebroplasty group (64% vs. 48%, P=0.06). At 3 months, there was a higher crossover rate in the control group than in the vertebroplasty group (51% vs. 13%, P<0.001) [corrected]. There was one serious adverse event in each group.
Improvements in pain and pain-related disability associated with osteoporotic compression fractures in patients treated with vertebroplasty were similar to the improvements in a control group. (ClinicalTrials.gov number, NCT00068822.)
Vertebroplasty has become a common treatment for painful osteoporotic vertebral fractures, but there is limited evidence to support its use.
We performed a multicenter, randomized, double-blind, placebo-controlled trial in which participants with one or two painful osteoporotic vertebral fractures that were of less than 12 months' duration and unhealed, as confirmed by magnetic resonance imaging, were randomly assigned to undergo vertebroplasty or a sham procedure. Participants were stratified according to treatment center, sex, and duration of symptoms (< 6 weeks or > or = 6 weeks). Outcomes were assessed at 1 week and at 1, 3, and 6 months. The primary outcome was overall pain (on a scale of 0 to 10, with 10 being the maximum imaginable pain) at 3 months.
A total of 78 participants were enrolled, and 71 (35 of 38 in the vertebroplasty group and 36 of 40 in the placebo group) completed the 6-month follow-up (91%). Vertebroplasty did not result in a significant advantage in any measured outcome at any time point. There were significant reductions in overall pain in both study groups at each follow-up assessment. At 3 months, the mean (+/-SD) reductions in the score for pain in the vertebroplasty and control groups were 2.6+/-2.9 and 1.9+/-3.3, respectively (adjusted between-group difference, 0.6; 95% confidence interval, -0.7 to 1.8). Similar improvements were seen in both groups with respect to pain at night and at rest, physical functioning, quality of life, and perceived improvement. Seven incident vertebral fractures (three in the vertebroplasty group and four in the placebo group) occurred during the 6-month follow-up period.
We found no beneficial effect of vertebroplasty as compared with a sham procedure in patients with painful osteoporotic vertebral fractures, at 1 week or at 1, 3, or 6 months after treatment. (Australian New Zealand Clinical Trials Registry number, ACTRN012605000079640.)
The aim of this paper was to assess the efficacy of a minimally invasive treatment with percutaneous vertebroplasty and kyphoplasty for traumatic fracture of thoracolumbar junction. Treatment of stable traumatic vertebral fractures of the thoracolumbar junction without neurological deficit is still controversy. Conservative treatment, characterized by discomfort and limitation in patient mobility, was progressively replaced by minimally invasive techniques such as percutaneous vertebroplasty and kyphoplasty.
Between January 2003 and August 2005, 34 patients suffering from 42 thoracolumbar fractures were treated at Neurosurgical Department of Istituto Galeazzi (Milan). The treatment selected (vertebroplasty versus kyphoplasty), depended on age of patients, timing and type of fracture. Results were clinically assessed by Visual Analogue Score (VAS) and Oswestry Disability Index.
Mean preoperative VAS was 8.32 (range 5-10). Percutaneous vertebroplasty was performed in 25 cases (73.5%); while 9 patients were treated by kyphoplasty (27.5%); 27 patients showed a single level and 7 multilevel of the fractures. No complications occurred (infection, neurological deficit, embolic events) after treatment. At the early follow-up 91.7% of the patients achieved a good pain control already after 24 hours. Pain relief and disability, analyzed by VAS and Oswestry Disability Index, showed a good results at late follow-up time.
Percutaneous vertebroplasty and kyphoplasty are two safe and effective techniques for treatment of thoracolumbar traumatic fractures and allow a good pain-control and return to normal working activity and social life.
Vertebroplasty-percutaneous cement augmentation of osteoporotic vertebrae is an efficient procedure for the treatment of painful vertebral fractures. From a prospectively monitored series of 70 patients with 193 augmented vertebrae for osteoporotic and metastatic lesions, we analysed a group of 17 patients suffering from back pain due to osteoporotic fractures. The reinforcement of 45 vertebral bodies in these patients led to a significant and lasting pain reduction (P < 0.01 ). The presented technique is useful, as, in one session, at least four injections can be performed when required, allowing the prophylactic reinforcement of adjacent vertebrae as well. The use of a low-viscosity polymethyl methacrylate (PMMA) in combination with a non-ionic liquid contrast dye provides a reliable and safe procedure. Extraosseous cement leakage was seen in 20% of the interventions; however, none of them had clinical sequelae.
Vertebroplasty--percutaneous cement augmentation of vertebral bodies--is an efficient procedure for the treatment of painful vertebral fractures in osteoporosis. At the present time, polymethylmethacrylate (PMMA) is the only available cement with reports of clinical application and experience. The material is easy to handle, the radiopacity can be adapted by adding contrast dye, and it is mechanically efficient. Composite cements (acrylic cements in conjunction with ceramics) are bioactive, highly radiopaque, and feature excellent mechanical properties. One such cement, Cortoss, is currently undergoing clinical trials for vertebroplasty and has so far been shown to be a potentially valuable alternative to PMMA. Several in vitro studies with injectable calcium phosphate (CaP) cements show their feasibility and mechanical effectiveness. Animal studies confirm their biocompatibility and osteoconductivity. However, handling problems and the limited radiopacity of these cements currently preclude their clinical use.
Previous studies have retrospectively reported the positive effects of percutaneous vertebroplasty. The purpose of our study was to evaluate prospectively the effects of vertebroplasty on mobility, analgesic use, pain, and SF-36 (short-form 36-item) scales for patients with painful vertebral compression fractures that are refractory to medical therapy.
We prospectively followed 167 patients who received 207 vertebroplasty treatment sessions for stabilization of 264 symptomatic vertebral compression fractures between August 1999 and January 2003. The average age of patients was 74.6 years (SD = 12.2 years), and 76% were women. Pre- and postprocedural measurements of pain, mobility, analgesic use, and SF-36 scales were compared at 1 month after the procedure and between 6 months and 3 years after the procedure with the SF-36 scales.
Respective pre- and post-treatment pain scores were 8.71 (SE = 0.1) and 2.77 (SE = 0.18; P < .00001). Respective pre- and post-treatment analgesic use scores were 2.93 (SE = 0.9) and 1.64 (SE = 0.09; P < .00001). Respective pre- and post-treatment activity levels were 2.66 (SE = 0.1) and 1.64 (SE = 0.11; P < .00001). There was a statistically significant improvement on nine of 10 SF-36 scales (P < .001) after 1 month and on eight of 10 SF-36 scales (P < .02) at long-term follow-up.
Percutaneous vertebroplasty offers statistically significant benefits in decreasing pain, decreasing use of analgesics, and increasing mobility in appropriately selected patients. Percutaneous vertebroplasty also offers a statistically significant benefit in most SF-36 scales at both short- and long-term follow-up.
To retrospectively evaluate complications of percutaneous vertebroplasty (PV) performed with polymethylmethacrylate cement to treat pain in patients with metastases to the spine.
This study had institutional review board approval; patient informed consent for the review of records and images was not required. In 2 years, 117 patients (38 men [32.5%] and 79 women [67.5%]; mean age, 58.2 years) underwent 159 fluoroscopy-guided PV procedures to treat 304 vertebrae. Spinal metastases included osteolytic, osteoblastic, and mixed lesions. Complications were characterized as local or systemic. Evaluated data included immediate imaging findings (on radiographs and computed tomographic scans) and clinical findings at 30-day follow-up. Chi2 or Fisher exact testing was performed for univariate analysis of variables.
The primary cancers were breast cancers (45.3%), lung cancers (14.5%), myeloma (7.7%), or other cancers (32.5%). Among the 423 cement leakages identified, 332 (78.5%) were vascular and 91 (21.5%) were nonvascular. Vascular leaks were classified as venous epidural leaks, paravertebral and foraminal plexus leaks, and leaks to the vena cava, while nonvascular leaks included puncture trajectory leaks, paravertebral soft tissue leaks, and diskal leaks. Patients with nonvascular leaks were asymptomatic. Eight (6.8%) patients experienced complications, and seven of these complications were symptomatic. Among these eight patients, six (5.1%) had local complications (puncture site hematoma in two patients and radicular pain [successfully treated with nonsteroidal anti-inflammatory drugs or corticosteroids] in four patients), and two (1.7%) had systemic complications (pulmonary embolism resulting from cement migration through the vena cava). One of the latter patients died. Univariate analyses revealed a significant association between cement migration through the vena cava and pulmonary embolism (P = .001) but not between foraminal venous leakage and radicular pain (P = .123).
Despite numerous technical incidents (leaks), PV-induced complications were rare, leading to the hypothesis that systemic complications are a consequence of intravascular leakage while local complications are a consequence of cement-related irritation, compression and/or ischemia, and/or needle-induced trauma.
Systematic literature review.
To evaluate the safety and efficacy of vertebroplasty and kyphoplasty using the data presented in published clinical studies, with respect to patient pain relief, restoration of mobility and vertebral body height, complication rate, and incidence of new adjacent vertebral fractures.
Vertebroplasty and kyphoplasty have been gaining popularity for treating vertebral fractures. Current reviews provide an overview of the procedures but are not comprehensive and tend to rely heavily on personal experience. This article aimed to compile all available data and evaluate the clinical outcome of the 2 procedures.
This is a systematic review of all the available data presented in peer-reviewed published clinical trials. The methodological quality of included studies was evaluated, and data were collected targeting specific standard measurements. Where possible, a quantitative aggregation of the data was performed.
A large proportion of subjects had some pain relief, including 87% with vertebroplasty and 92% with kyphoplasty. Vertebral height restoration was possible using kyphoplasty (average 6.6 degrees ) and for a subset of patients using vertebroplasty (average 6.6 degrees ). Cement leaks occurred for 41% and 9% of treated vertebrae for vertebroplasty and kyphoplasty, respectively. New fractures of adjacent vertebrae occurred for both procedures at rates that are higher than the general osteoporotic population but approximately equivalent to the general osteoporotic population that had a previous vertebral fracture.
The problem with stating definitely that vertebroplasty and kyphoplasty are safe and effective procedures is the lack of comparative, blinded, randomized clinical trials. Standardized evaluative methods should be adopted.
To assess patient outcome in a consecutive series of patients with myeloma and spinal metastases who underwent percutaneous vertebroplasty.
Data were gathered prospectively on all patients undergoing percutaneous vertebroplasty between June 2001 and June 2010. Outcome measures included visual analogue pain scores (VAS) and Roland-Morris Questionnaire (RMQ) in patients treated since 2005 as well as complications and long-term outcome in all patients.
One hundred and twenty-eight patients underwent percutaneous vertebroplasty for myeloma (n=41) or spinal metastases (n=87) over a 9 year period. VAS scores fell from 7.75 ± 1.88 pre-vertebroplasty to 4.77 ± 2.69 post-vertebroplasty (p=0.001). RDQ scores improved from 18.55 ± 4.79 to 13.5 ± 6.96 (p=0.001). Complications were recorded in three patients: cement extension to vena cava (n=1), local haematoma (n=1), and loss of sensation over T1 dermatome (n=1). The Kaplan-Meier estimate of 5 year survival post-vertebroplasty was 40% for patients with myeloma and 25% for those with metastases.
This large prospective study demonstrates percutaneous vertebroplasty reduces pain and improves disability in patients from intractable pain from myeloma or spinal metastases and now forms an important part of the multimodality treatment for these patients.
To establish the efficacy and complications associated with vertebroplasty in spinal metastases and myeloma.
A literature search was performed from inception to April 2010. Thirty relevant studies were identified. Only one was a randomized, controlled trial and seven were prospective studies. Nine hundred and eighty-seven patients aged between 45 and 72 years were included in this systematic review.
Most studies report performing the procedure under local anaesthetic and continuous fluoroscopic screening, and only two centres reported treating more than four vertebrae per session. Five deaths were attributable to vertebroplasty, with a further 19 patients suffering a serious complication related to the procedure. There is some evidence to suggest that the complication rate may be related to the higher cement volume used, although the data are not robust enough for meta-analysis. Pain reduction ranged between 47-87%, similar to the results for osteoporosis. There was no correlation between pain reduction and cement volume.
This systematic review reveals the paucity of good-quality, robust data available on the subject of percutaneous vertebroplasty in malignancy. It also highlights the apparent high risk of serious complication (2%). Further research into the subject is required in this group of patients.
Percutaneous vertebral augmentation techniques performed with vertebroplasty or kyphoplasty are safe and effective for the treatment of osteoporotic vertebral compression fractures, primary or secondary spine tumors, and selected traumatic fractures. This article compares the procedures and outlines their advantages and disadvantages. It concludes that vertebroplasty should be performed in most cases, but kyphoplasty is preferable in selected cases.
Vertebral fractures (VF) are a leading cause of morbidity in the elderly. In the past decade, minimally invasive bone augmentation techniques for VF, such as percutaneous vertebroplasty (VP) and kyphoplasty (KP) have become more widespread. According to the literature, both techniques provide significant pain relief. However, KP is more expensive and technically more demanding than VP. The current study surveyed German surgeons who practice percutaneous augmentation to evaluate and compare decisions regarding the implementation of these techniques. Is there a difference in the indications and contraindications of VP and KP compared with the interdisciplinary consensus paper on VP and KP of the German medical association in the treatment of VF?
A multiple choice questionnaire was designed with questions regarding diagnostic procedures, clinical and radiologic (AO classification) indications, as well as contraindications for both VP and KP. A panel of five experts refined the initial questionnaire. The final version was then sent to 580 clinics registered to practice KP in Germany. The statistical analysis was done by two authors, who collected the questionnaire data and Wilcoxon's signed ranks test was performed for non-parametric variables with SPSS.
327 of 580 questionnaires (56.4%) were completed and returned. 151 (46.2%) of participants were performing both procedures, and 176 (53.8%) performed KP only. Median duration from onset of acute pain to intervention was 3 weeks. For most participants (95.4%), consistent back pain at the fracture level with a visual analog scale score over 5 was the main clinical indication for VP and KP. A1 and A3.1 fractures from osteoporosis and metastasis were considered indications for KP. Osteoporotic A1.1 fractures were an indication for VP. Traumatic A3.2 fractures were not an indication for either procedure. Major contraindications to both procedures were active infection (94.7%), cement allergy (86.8%), and coagulation disorders (80.3%).
Vertebroplasty and kyphoplasty both have roles in the treatment of vertebral fractures. However, we could see differences in the indications for the two percutaneous techniques. Participants of this study found more indications for KP versus VP in cases of painful A1.2 and A3.1 fractures due to osteoporosis, metastasis, and trauma. About half of the respondents reported that VP is indicated for osteoporotic and pathologic A1.1 fractures. This study offers only limited conclusions. Open questionnaires and prospective data from all clinicians performing these procedures should be analyzed to offer more specific information.
This study aimed to assess the role of percutaneous vertebroplasty (VP) in the management of acute traumatic burst fractures. We describe three cases where percutaneous VP was carried out for traumatic non-osteoporotic burst vertebral fractures. For clinical symptoms and the effect of the VP procedure to be assessed, all patients completed a visual analogue scale and a mobility score before the procedure and at day 1 and 3 months post procedure. Improvements in both pain and mobility scores immediately post procedure were seen in all patients, and these results persisted at 3-month follow up. Percutaneous VP provided a successful, minimally invasive treatment of these patients' traumatic fractures while avoiding major surgical procedures and associated surgical morbidity and complications.
Worldwide there are approximately 1.4 million persons with vertebral compression fractures.1 In the United States, there are approximately 750,000; only one third receive treatment.2 Prevalence estimates are imprecise because of heterogeneity in how vertebral fracture is defined.3 Annualized direct care expenditures for osteoporotic fractures in the United States were estimated to range from $12 billion to $18 billion in 2002.2 Several treatments (e.g., bed rest, bracing, and pain medications) have been designed to foster pain relief and allow for increased activities. Percutaneous vertebroplasty — the injection of polymethylmethacrylate directly into the vertebral compression fracture — has emerged as a treatment . . .
To investigate the causes and preventive methods of the bone cement leakage in percutaneous kyphoplasty (PKP) for osteoporotic vertebral body compression fracture (OVCF).
From April 2003 to November 2007, 116 patients with OVCF were treated with PKP, including 57 males and 59 females aged 65-92 years old (average 67.7 years old). All the patients suffered from trauma and the course of disease was 1-14 days (average 5.7 days). There were 159 compressed and fractured vertebral bodies, including one vertebral body in 83 cases, two vertebral bodies in 24 cases, three vertebral bodies in 8 cases, and four vertebral bodies in 1 case. The diagnosis of OVCF was confirmed by imaging examination before operation. All the patients had intact posterior vertebral walls, without symptoms of spinal and nerve root injury. During operation, 3.5-7.1 mL bone cement (average 4.8 mL) was injected into single vertebral body.
The operation time was 30-90 minutes (average 48 minutes). Obvious pain relief was achieved in all the patients after operation. X-rays examination 2 days after operation revealed that the injured vertebral bodies were well replaced without further compression and deformation, and the bone cement was evenly distributed. Fourteen vertebral bodies had bone cement leakage (4 of anterior leakage, 4 of lateral leakage, 3 of posterior leakage, 2 of intervertebral leakage, 1 of spinal canal leakage). The reason for the bone cement leakage included the individuality of patient, the standardization of manipulation and the time of injecting bone cement. During the follow-up period of 12-30 months (average 24 months), all the patients got their normal life back, without pain, operation-induced spinal canal stenosis, obvious height loss of injured vertebral bodies and other complications.
For OVCF, PKP is a mini-invasive, effective and safe procedure that provides pain relief and stabilization of spinal stability. The occurrence of bone cement leakages can be reduced by choosing the suitable case, improving the viscosity of bone cement, injecting the proper amount of bone cement and precise location during operation.
Vertebroplasty (VP) and kyphoplasty (KP) are routinely used to treat vertebral body compression fractures (VCFs) resulting from osteoporosis or vertebral body tumors in order to provide rapid pain relief. However, it remains debated whether VP or KP results in superior outcomes versus medical management alone in patients experiencing VCFs.
To determine the level of evidence supporting VP or KP for the treatment of VCFs.
Systematic review of the literature.
Patients with osteoporotic or tumor-associated VCFs.
Self-reported and functional measures.
We reviewed all articles published between 1980 and 2008 reporting outcomes after VP or KP for osteoporotic or tumor-associated VCFs and rated the level of evidence and grades of recommendation (per North American Spine Society [NASS] guidelines) supporting the use of VP or KP for the treatment of VCFs.
Seventy-four VP studies for osteoporotic VCF (1 level I, 3 level II, 70 level IV), 35 KP studies for osteoporotic VCF (2 level II, 33 level IV), and 18 VP/KP for tumor VCFs (all level IV) were reviewed. There is good evidence (level I) that VP results in superior pain control within the first 2 weeks of intervention compared with optimal medical management for osteoporotic VCFs. There is fair evidence (level II-III) that VP results in less analgesia use, less disability, and greater improvement in general health when compared with optimal medical management within the first 3 months after intervention. There is fair evidence (level II-III) that by 2 years after intervention, VP provides a similar degree of pain control and physical function as optimal medical management. There is fair evidence (level II-III) that KP results in greater improvement in daily activity, physical function, and pain relief when compared with optimal medical management for osteoporotic VCFs by 6 months after intervention. There is poor-quality evidence that VP or KP results in greater pain relief for tumor-associated VCFs.
Although evidence suggests that physical disability, general health, and pain relief are better with VP and KP than those with medical management within the first 3 months after intervention, high-quality randomized trials with 2-year follow-up are needed to confirm this. Furthermore, the reported incidence of symptomatic procedure-related morbidity for both VP and KP is very low.
Percutaneous vertebroplasty (PVP) using polymethylmethacrylate bone cement is frequently used in the treatment of painful osteoporotic vertebral compression fractures in the Netherlands. In three patients there was another indication. A 44-year-old woman suffering from vertebral pain due to an osteolytic lesion caused by multiple myeloma was treated with vertebroplasty of 4 vertebral levels. A 60-year-old woman with progressive complaints of back pain due to an aggressive vertebral haemangioma was treated with vertebroplasty after embolisation had only been partially successful. Lastly, a 50-year-old non-osteoporotic man with back pain persisting for six weeks due to a stable traumatic burst fracture of TIX could not be treated with standard care, i.e. corset and analgesics, because of obesity. He was treated with PVP after a cavity had been created in the vertebral corpus. Vertebroplasty is a minimal invasive procedure resulting in most patients in rapid diminishment of the pain caused by pathological vertebral fractures, which may be present for a longer period and may have different causes. The indication triad for vertebroplasty consists of localised back pain, pain when pressure is applied to the processus spinosus of the fractured level and MRI bone oedema, findings suggestive of microfractures in a pathologically changed vertebral body. The procedure is also suitable in patients with extensive comorbidity or a short life expectancy.
Destructive biomechanical tests using fresh cadaveric thoracolumbar vertebral bodies.
To evaluate the compression strength of human vertebral bodies injected with a new calcium phosphate (CaP) cement with improved infiltration properties for augmentation of the vertebral bodies before compression fracture and also for vertebroplasty in comparison with polymethylmethacrylate (PMMA) injection.
Vertebroplasty is the percutaneous injection of PMMA cement into the vertebral body. While PMMA has high mechanical strength, it cures fast and thus allows only a short handling time. Other potential problems of using PMMA injection may include damage to surrounding tissues by a high polymerization temperature or by the unreacted toxic monomer, and the lack of long-term biocompatibility. Bone mineral cements, such as calcium carbonate and CaP cements, have longer working time and low thermal effect. They are also biodegradable while having a good mechanical strength. However, the viscosity of injectable mineral cements is high, and the infiltration of these cements into vertebral body has been questioned. Recently, the infiltration properties of a CaP cement have been significantly improved, which is ideal for the transpedicular injection to the vertebral bodies for vertebroplasty or augmentation of osteoporotic vertebral body strength.
The bone mineral densities of 30 vertebral bodies (T2-L1) were measured using dual-energy x-ray absorptiometry. Ten control specimens were compressed at a loading rate of 15 mm/min to 50% of their original height. The other specimens had 6 mL of PMMA (n = 10) or the new CaP (n = 10) cement injected through the bilateral pedicle approach before being loaded in compression. Additionally, after the control specimens had been compressed, they were injected with either CaP (n = 5) or PMMA (n = 5) cement using the same technique, to simulate vertebroplasty. Loading experiments were repeated with the displacement control of 50% vertebral height. Load to failure was compared among groups and analyzed using analysis of variance.
Mean bone mineral densities of all five groups were similar and ranged from 0.56 to 0.89 g/cm2. The size of the vertebral body and the amount of cement injected were similar in all groups. Load to failure values for PMMA, the new CaP, and vertebroplasty PMMA were significantly greater than that of control. Load to failure of the vertebroplasty CaP group was higher than control but not statistically significant. The mean stiffness of the vertebroplasty CaP group was significantly smaller than control, PMMA, and the new CaP groups. The mean height gains after injection of the new CaP and PMMA cements for vertebroplasty were minimal (3.56% and 2.01%, respectively).
Results of this study demonstrated that the new CaP cement can be injected and infiltrates easily into the vertebral body. It was also found that injection of the new CaP cement can improve the strength of a fractured vertebral body to at least the level of its intact strength. Thus, the new CaP cement may be a good alternative to PMMA cement for vertebroplasty, although further in vivo animal and clinical studies should be done. Furthermore, the new CaP may be more effective in augmenting the strength of osteoporotic vertebral bodies for preventing compression fractures considering our biomechanical testing data and the known potential for biodegradability of the new CaP cement.
A case report and review of the literature are presented.
To present the first case of paraplegia as a complication of percutaneous vertebroplasty with polymethylmethacrylate in osteoporotic compression fracture.
Complications of percutaneous vertebroplasty with polymethylmethacrylate (PMMA) for the treatment of osteoporotic compression fracture were found to be rare and minor, except in two cases of major neurologic complication.
The reported case is that of a 66-year-old woman with multilevel vertebral osteopenia and compression fractures. Percutaneous vertebroplasty using polymethylmethacrylate was performed at three vertebral bodies (L2, L1, and T11) using careful techniques including venography, large cannula, proper preparation and amount of polymethylmethacrylate, and continuous visualization with fluoroscopy.
Immediately after surgery, the patient had complete motor and sensory deficits at T11. Computed tomography scan showed spinal cord compression caused by venous leakage of polymethylmethacrylate. In anticipation of recovery from paraplegia, posterior decompression was performed from L2 to T10.
Percutaneous vertebroplasty with polymethylmethacrylate is not as simple and risk free as advocated in the literature. Careful safeguards and modifications are needed for the procedure, and new and physiologic material could be substituted for polymethylmethacrylate.
Complications due to vertebroplasty may be divided into two categories whether or not they are related to polymethylmethacrylate (PMMA) cement leakage from the compressed vertebral body. PMMA leakage is a very frequent occurrence in vertebroplasty is also the main source of complications. Neurological complications are due to cement leakage into the spinal canal and less exceptionally into the intervertebral foramen. The transpedicular needle approach reduces the risk of cement leakage into the foramen. Pulmonary embolism of PMMA may occur when there is a failure to recognize venous migration of cement early during the procedure. Cortical destruction, presence of an epidural soft-tissue mass, highly vascularized lesions, and severe vertebral collapse are factors which increase the rate of complications, which is therefore much higher in metastatic than in osteoporotic vertebral collapse. Prevention of PMMA leakage-related complications is a multifactorial issue including procedure preparation, needle approach and placement, and cement application. The technical refinements which may help reduce the risk of PMMA leakage are reviewed in this article. Experimental data have shown that systemic reactions may occur during vertebroplasty in the absence of cement leakage. These reactions may be partly related to vascular embolism of bone marrow fat. Another controversial issue is a possible increase in the risk of vertebral collapse of adjacent vertebrae following vertebroplasty. Prospective randomized studies are needed to resolve this issue.
Osteoporotic vertebral compression fractures (VCFs) are being increasingly treated with minimally invasive bone augmentation techniques such as kyphoplasty and vertebroplasty. Both are reported to be an effective means of pain relief; however, there may be an increased risk of developing subsequent VCFs after such procedures.
The purpose of this study was to compare the effectiveness and complication profile of kyphoplasty and vertebroplasty in a single patient series.
A clinical series of 36 patients with VCFs treated by vertebral augmentation procedures was retrospectively analyzed for surgical approach, volume of cement injected, cement extravasation (symptomatic and asymptomatic), the occurrence of subsequent adjacent level fracture, and pain relief.
Thirty-six patients with 46 VCFs underwent either kyphoplasty or vertebroplasty after failing conservative therapy. The mean patient age was not significantly different between the kyphoplasty group (70; range, 46-83) and vertebroplasty group (72; range, 38-90) (p=.438).
Outcomes were assessed by using self-report measures (a comparative pain rating scale) and physiologic measures (pre- and postoperative radiographs).
Thirty-six patients with VCFs underwent 46 augmentation procedures (17 patients had 20 fractures treated via kyphoplasty, and 19 patients had 26 fractures treated via vertebroplasty). Seventeen patients in this series underwent kyphoplasty using standard techniques involving bone void creation with balloon tamps, followed by cement injection. Nineteen patients underwent a percutaneous vertebroplasty procedure using a novel cannulated, fenestrated bone tap developed to direct cement anteriorly into the vertebral body to avoid backflow of cement onto neural elements.
Pain improvement was seen in >90% of patients in both groups. Mean cement injection per vertebral body was 4.65 mL and 3.78 mL for the kyphoplasty and vertebroplasty groups, respectively (p=.014). Ninety-five percent of the kyphoplasty procedures were performed bilaterally, whereas only 19% of the vertebroplasty procedures required bilateral augmentation (p<.001). There was no cement extravasation resulting in radiculopathy, or myelopathy in either group. Asymptomatic cement extravasation was seen in 5 of 46 (11%) of the total series (3/20 [15%] and 2/26 [7.7%] of kyphoplasty and vertebroplasty, respectively) (p=.696). Within a 3-month period, there were 5 new adjacent level fractures seen in 3 patients who underwent a kyphoplasty procedure (5/20 [25%]) and none in the vertebroplasty group (p<.05).
Vertebroplasty appears to offer a comparable rate of postoperative pain relief as kyphoplasty while using less bone cement more often via a unilateral approach and without the attendant risk of adjacent level fracture.
Vertebral compression fractures occur more frequently than hip and ankle fractures combined. These fragility fractures frequently result in both acute and chronic pain, but more importantly are a source of increased morbidity and possibly mortality. Percutaneous veretebral augmentation offers a minimally invasive approach for the treatment of vertebral compression fractures. The history, technique, and results of vertebroplasty and kyphoplasty are reviewed. Both methods allow for the introduction of bone cement into the fracture site with clinical results indicating substantial pain relief in approximately 90% of patients.
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