Balloon kyphoplasty for the treatment of acute vertebral compression fractures: 2-year results from a randomized trial

Abstract

Vertebral fractures are often painful and lead to reduced quality of life and disability. We compared the efficacy and safety of balloon kyphoplasty to nonsurgical therapy over 24 months in patients with acute painful fractures. Adults with one to three vertebral fractures were randomized within 3 months from onset of pain to undergo kyphoplasty (n ¼ 149) or nonsurgical therapy (n ¼ 151). Quality of life, function, disability, and pain were assessed over 24 months. Kyphoplasty was associated with greater improvements in Short-Form 36 (SF-36) Physical Component Summary (PCS) scores when averaged across the 24-month follow-up period compared with nonsurgical therapy [overall treatment effect 3.24 points, 95% confidence interval (CI) 1.47-5.01, p ¼ .0004]; the treatment difference remained statistically significant at 6 months (3.39 points, 95% CI 1.13-5.64, p ¼ .003) but not at 12 months (1.70 points, 95% CI À0.59 to 3.98, p ¼ .15) or 24 months (1.68 points, 95% CI À0.63 to 3.99, p ¼ .15). Greater improvement in back pain was observed over 24 months for kyphoplasty (overall treatment effect À1.49 points, 95% CI À1.88 to À1.10, p < .0001); the difference between groups remained statistically significant at 24 months (À0.80 points, 95% CI À1.39 to À0.20, p ¼ .009). There were two device-related serious adverse events in the second year that occurred at index vertebrae (a spondylitis and an anterior cement migration). There was no statistically significant difference between groups in the number of patients (47.5% for kyphoplasty, 44.1% for control) with new radiographic vertebral fractures; fewer fractures occurred ($18%) within the second year. Compared with nonsurgical management, kyphoplasty rapidly reduces pain and improves function, disability, and quality of life without increasing the risk of additional vertebral fractures. The differences from nonsurgical management are statistically significant when averaged across 24 months. Most outcomes are not statistically different at 24 months, but the reduction in back pain remains statistically significant at all time points. ß

Meta-analysis of vertebral augmentation compared with conservative treatment for osteoporotic spinal fractures

“…For continuous variables, the standardized mean difference (Hedges's g) for each study was calculated by comparing improvement from baseline of the experimental group to the control group using the ''intention to treat'' analysis when reported. The new vertebral fracture risk for (2) Buchbinder et al (1) Wardlaw et al (3) and Boonen et al (9) Voormolen et al (10) Farrokhi et al (4) Klazen et al (5) Rousing et al (12) …”

“…and Boonen et al (9) Voormolen et al (10) Farrokhi et al (4) Klazen et al (5) Rousing et al (12) Results Sensitivity analysis was performed to detect bias by sequential removal of each study from the analysis. Further, the correlation between preoperative and follow-up outcomes was adjusted, ranging from 0.1 to 0.9.…”

“…Another study was an update of another investigation, leaving a total of six RCTs for meta-analysis. (9) As a result, a total of six unique RCTs were ultimately used in our meta-analysis. The objectives, number of patients, methods, results, adverse events, and authors' conclusions from all the studies were tabulated (Table 1).…”

Balloon kyphoplasty versus percutaneous vertebroplasty in treating osteoporotic vertebral compression fracture: grading the evidence through a systematic review and meta-analysis

“…The MINORS quality scores of the nonRCTs are presented in Table 1. The mean score was 12.8 (range, [8][9][10][11][12][13][14][15][16], which corresponded to a 53 % score. This result indicated that there was considerable variability in the evidence base.…”

“…Recently, two randomized controlled trials (RCTs) have indicated that both of the procedures can produce immediate pain relief than conservative treatments [19,47]. In 2011, an RCT with 24 months of follow-up reported that kyphoplasty reduced pain and improved function, disability and quality of life more effectively than nonsurgical therapy without increasing the risk of additional vertebral fractures [8].…”