STUDY DESIGN: Forty patients were enrolled in 2 FDA-approved pilot Investigational Device Exemption (IDE) studies using Cortoss for the treatment of vertebral compression fractures (VCF). Twenty patients were treated at 3 centers, using vertebroplasty (VP) and 20 patients were treated at 5 centers, using kyphoplasty (KP).
OBJECTIVE: To assess the feasibility and clinical outcomes using Cortoss to treat osteoporotic VCF.
SUMMARY OF BACKGROUND DATA: Cortoss is an injectable bioactive, self-setting, radiopaque composite shown to stabilize and provide immediate weight bearing support to fractured vertebrae. Cortoss is approved for use in Europe for both screw and vertebral augmentation. METHODS.: Patient assessments were conducted before surgery and after surgery through 24 months using Visual Analog Scale (VAS), Oswestry Disability Index (ODI), and quality-of-life assessment (SF-12) questionnaires. Extravasations were evaluated using radiographs and CT scans.
RESULTS: Immediate pain improvement was seen in VP patients with VAS scores decreasing from 75.7 before surgery to 35.9 at 72 hours. Continued improvement from baseline was seen out to 2 years (average VAS of 48.9). Disability improved with average ODI scores decreasing from 52.2% preoperative to 38.3% at 2 years for VP patients. Immediate pain improvement was also seen in KP patients with VAS scores decreasing from 78.1 before surgery to 42.7 at 72 hours. Continued improvement from baseline was seen out to 2 years (average VAS of 25.4). ODI scores improved from 60.5% preoperative to 34.5% at 2 years for KP patients. Average material volumes injected were 1.85 mL for VP and 4.13 mL for KP. Extravasations from both techniques were minor, anatomically close to the treated vertebrae and asymptomatic. No cardiac irregularities or pulmonary emboli were observed.
CONCLUSION: These studies indicate Cortoss is safe and effective in treating osteoporotic VCF using vertebroplasty or kyphoplasty. Pain relief and restoration of function with Cortoss is comparable to results found in the literature for polymethylmethacrylate.
BACKGROUND: Percutaneous vertebroplasty is increasingly used for treatment of pain in patients with osteoporotic vertebral compression fractures, but the efficacy, cost-effectiveness, and safety of the procedure remain uncertain. We aimed to clarify whether vertebroplasty has additional value compared with optimum pain treatment in patients with acute vertebral fractures.
METHODS: Patients were recruited to this open-label prospective randomised trial from the radiology departments of six hospitals in the Netherlands and Belgium. Patients were aged 50 years or older, had vertebral compression fractures on spine radiograph (minimum 15% height loss; level of fracture at Th5 or lower; bone oedema on MRI), with back pain for 6 weeks or less, and a visual analogue scale (VAS) score of 5 or more. Patients were randomly allocated to percutaneous vertebroplasty or conservative treatment by computer-generated randomisation codes with a block size of six. Masking was not possible for participants, physicians, and outcome assessors. The primary outcome was pain relief at 1 month and 1 year as measured by VAS score. Analysis was by intention to treat. This study is registered at ClinicalTrials.gov, number NCT00232466.
FINDINGS: Between Oct 1, 2005, and June 30, 2008, we identified 431 patients who were eligible for randomisation. 229 (53%) patients had spontaneous pain relief during assessment, and 202 patients with persistent pain were randomly allocated to treatment (101 vertebroplasty, 101 conservative treatment). Vertebroplasty resulted in greater pain relief than did conservative treatment; difference in mean VAS score between baseline and 1 month was -5·2 (95% CI -5·88 to -4·72) after vertebroplasty and -2·7 (-3·22 to -1·98) after conservative treatment, and between baseline and 1 year was -5·7 (-6·22 to -4·98) after vertebroplasty and -3·7 (-4·35 to -3·05) after conservative treatment. The difference between groups in reduction of mean VAS score from baseline was 2·6 (95% CI 1·74-3·37, p<0·0001) at 1 month and 2·0 (1·13-2·80, p<0·0001) at 1 year. No serious complications or adverse events were reported.
INTERPRETATION: In a subgroup of patients with acute osteoporotic vertebral compression fractures and persistent pain, percutaneous vertebroplasty is effective and safe. Pain relief after vertebroplasty is immediate, is sustained for at least a year, and is significantly greater than that achieved with conservative treatment, at an acceptable cost.
FUNDING: ZonMw; COOK Medical.
PURPOSE: The aim of this study was to compare the effectiveness of percutaneous vertebroplasty and kyphoplasty to treat pain from non-neoplastic vertebral fractures and improve functional outcomes.
MATERIALS AND METHODS: We compared 30 patients treated by vertebroplasty for non-neoplastic vertebral fractures with 30 patients treated by kyphoplasty for the same condition. Pain was measured with a visual analogue scale (VAS) and functional outcome with the Oswestry disability index (ODI). Baseline data were compared with measurements on the day after the procedure (for pain alone) and at 1 month, 6 months, and 1 year.
RESULTS: The VAS pain score was reduced by 4-5 points on the day after either type of treatment, a statistically significant improvement. The global ODI was significantly improved (by 13-18 points) at 1 month after either procedure. These improvements persisted at 6 months and 1 year. No significant differences in functional outcome were observed between the techniques.
CONCLUSION: Vertebroplasty and kyphoplasty obtain similar improvements in pain and functional outcomes in these patients. The choice of technique must therefore depend on other factors. An initial improvement with either technique is a good predictor of long-term improvement.
INTRODUCTION: It is still controversial whether adjacent level compression fractures after balloon kyphoplasty (BK) and vertebroplasty (VP) should be regarded as the consequence of stiffness achieved by augmentation with bone cement or if the adjacent level fractures are simply the result of the natural progression of osteoporosis. The purpose of this study was to evaluate the adjacent level fracture risk after BK as compared with VP and to determine the possible dominant risk factor associated with new compression fractures.
MATERIALS AND METHODS: 73 consecutive patients with painful vertebral compression fractures (VCFs) were enrolled in a prospective nonrandomized study. BK was performed in 46 patients (51 vertebral bodies) and VP in 27 patients (32 vertebral bodies). The first patient's visit was before the operative procedure, when clinical and radiographical examinations were done. The follow-up visits, considered in the analysis, were on the first day and after 1 year, postoperatively.
RESULTS: In 1 year, 3 out of 46 patients (6.5%) treated with BK, and 2 out of 27 patients (7.4%) treated with VP sustained adjacent level fracture. More patients with a BMD higher or equal to 3.0 experienced a new fracture than those with a BMD less than 3.0 (odds ratio = 13.00; 95% confidence interval: 1.35-124.81), and the risk for adjacent level fractures decreased significantly when the postoperative kyphotic angle was less than 9 degrees compared with that of higher or equal to 9 degrees (odds ratio = 12.00; 95% confidence interval: 1.25-114.88).
CONCLUSION: Our results indicate that BK and VP are methods with a low risk of adjacent level fractures. The most important factors for new VCFs after a percutaneous augmentation procedure are the degree of osteoporosis and altered biomechanics in the treated area of the spine due to resistant kyphosis. These results suggest that the adjacent vertebrae would fracture eventually, even without the procedure. BK and VP offer a comparable rate of pain relief.
PURPOSE: Kyphoplasty immediately improves pain and mobility in patients with painful osteoporotic vertebral fractures, but long-term clinical outcomes are still unclear. This controlled trial evaluates pain, mobility and fracture incidence 3 years after kyphoplasty.
MATERIALS AND METHODS: Kyphoplasty was performed in 40 patients with painful osteoporotic vertebral fractures; 20 patients who were selected for kyphoplasty but chose not to undergo the procedure served as controls. All patients received pharmacologic antiosteoporosis treatment, pain medication, and physiotherapy. Pain (visual analog scale of 0-100), mobility (European Vertebral Osteoporosis Study questionnaire score of 0-100), and incident vertebral fractures were assessed at baseline, postprocedurally, and after 12 and 36 months.
RESULTS: Pain score improved after kyphoplasty from 73.8 to 55.9 (immediately after kyphoplasty), 55.6 (12 months), and 54.0 (36 months; P < .001). Pain score in the control group changed from 66.4 to 65.7 at 12 months and 64.0 at 36 months (P = .521). The pain score of the kyphoplasty group was significantly improved versus controls after 36 months (P = .023). Mobility score improved after kyphoplasty from 43.8 to 54.2 (immediately after kyphoplasty), 54.5 (12 months), and 54.8 (36 months; P = .0008) and remained increased (P = .308) compared with controls (39.8 immediately after kyphoplasty, 44.3 at 12 months, and 43.6 at 36 months). The incidence of new vertebral fractures after kyphoplasty was significantly reduced versus controls after 3 years (P = .0341).
CONCLUSIONS: Kyphoplasty reduces pain and improves mobility as long as 3 years after the procedure. The long-term risk of new vertebral fractures after kyphoplasty of chronically painful vertebral fractures is reduced versus controls.
BACKGROUND: The most common complication of osteoporosis is vertebral fractures, which occur more frequently than all other fractures (hip, wrist, and ankle).
OBJECTIVE: To prospectively analyze vertebroplasty compared with kyphoplasty for the treatment of osteoporotic vertebral compression fractures using improvement in pain, functional capacity, and quality of life as outcome measures.
METHODS: The study population included 28 patients in the vertebroplasty group and 24 patients in the kyphoplasty group. The mean follow-up period was 42.2 weeks and 42.3 weeks in the vertebroplasty and kyphoplasty groups, respectively. Outcomes were measured pre- and postoperatively using the visual analogue scale, the Oswestry Disability Index, the EuroQol-5D questionnaire, and the Short-Form 36 Health Survey.
RESULTS: In the vertebroplasty group, visual analogue scale scores improved from a mean of 8.0 cm to 5.5 cm at last follow-up (P = .001). Preoperatively, the Oswestry Disability Index was 57.6, which improved to 38.4 (P = .006). The EuroQol-5D score preoperatively was 0.157 and improved to 0.504 (P = .001). The Short-Form 36 Health Survey showed greatest improvement in the areas of physical health, role physical, body pain, and vitality. In the kyphoplasty group, visual analogue scale scores improved from a mean of 7.5 cm preoperatively to 2.5 cm postoperatively (P = .000001). The mean Oswestry Disability Index preoperatively was 50.7 and improved to 28.8 (P = .002). The EuroQol-5D score improved from a mean of 0.234 preoperatively to 0.749 (P = .00004). The Short-Form 36 Health Survey showed greatest improvement in the areas of physical health, physical functioning, role physical, body pain, and social functioning.
CONCLUSION: Both vertebroplasty and kyphoplasty are effective at improving pain, functional disability, and quality of life; however, kyphoplasty provides better results, which are maintained over long-term follow-up.
Forty patients were enrolled in 2 FDA-approved pilot Investigational Device Exemption (IDE) studies using Cortoss for the treatment of vertebral compression fractures (VCF). Twenty patients were treated at 3 centers, using vertebroplasty (VP) and 20 patients were treated at 5 centers, using kyphoplasty (KP).
OBJECTIVE:
To assess the feasibility and clinical outcomes using Cortoss to treat osteoporotic VCF.
SUMMARY OF BACKGROUND DATA:
Cortoss is an injectable bioactive, self-setting, radiopaque composite shown to stabilize and provide immediate weight bearing support to fractured vertebrae. Cortoss is approved for use in Europe for both screw and vertebral augmentation. METHODS.: Patient assessments were conducted before surgery and after surgery through 24 months using Visual Analog Scale (VAS), Oswestry Disability Index (ODI), and quality-of-life assessment (SF-12) questionnaires. Extravasations were evaluated using radiographs and CT scans.
RESULTS:
Immediate pain improvement was seen in VP patients with VAS scores decreasing from 75.7 before surgery to 35.9 at 72 hours. Continued improvement from baseline was seen out to 2 years (average VAS of 48.9). Disability improved with average ODI scores decreasing from 52.2% preoperative to 38.3% at 2 years for VP patients. Immediate pain improvement was also seen in KP patients with VAS scores decreasing from 78.1 before surgery to 42.7 at 72 hours. Continued improvement from baseline was seen out to 2 years (average VAS of 25.4). ODI scores improved from 60.5% preoperative to 34.5% at 2 years for KP patients. Average material volumes injected were 1.85 mL for VP and 4.13 mL for KP. Extravasations from both techniques were minor, anatomically close to the treated vertebrae and asymptomatic. No cardiac irregularities or pulmonary emboli were observed.
CONCLUSION:
These studies indicate Cortoss is safe and effective in treating osteoporotic VCF using vertebroplasty or kyphoplasty. Pain relief and restoration of function with Cortoss is comparable to results found in the literature for polymethylmethacrylate.
