Pain, quality of life and safety outcomes of kyphoplasty for vertebral compression fractures: report of a task force of the American Society for Bone and Mineral Research.

摘要

The relative efficacy and harms of balloon kyphoplasty (BK) for treating vertebral compression fractures (VCF) are uncertain. We searched multiple electronic databases to March 2016 for randomised and quasi-randomised controlled trials comparing BK with control treatment (non-surgical management [NSM], percutaneous vertebroplasty [PV], KIVA®, vertebral body stenting, or other) in adults with VCF. Outcomes included back pain, back disability, quality of life (QoL), new VCF and adverse events (AE). One reviewer extracted data, a second checked accuracy, and two rated risk of bias (ROB). Mean differences and 95% confidence intervals were calculated using inverse-variance models. Risk ratios of new VCF and AE were calculated using Mantel-Haenszel models. Ten unique trials enrolled 1,837 participants (age range: 61-76 years, 74% female), all rated as having high or uncertain ROB. Versus NSM, BK was associated with greater reductions in pain, back-related disability, and better QoL (k = 1 trial) that appeared to lessen over time, but were less than minimally clinically important differences. Risk of new VCF at 3 and 12 months was not significantly different (k = 2 trials). Risk of any AE was increased at 1 month (RR = 1.73 [1.36, 2.21]). There were no significant differences between BK and PV in back pain, back disability, QoL, risk of new VCF or any AE (k = 1 to 3 trials). Limitations included lack of a BK versus sham comparison, availability of only one RCT of BK versus NSM, and lack of study blinding. Individuals with painful VCF experienced symptomatic improvement compared with baseline with all interventions. The clinical importance of the greater improvements with BK versus NSM is unclear, may be due to placebo effect, and may not counterbalance short-term AE risks. Outcomes appeared similar between BK and other surgical interventions. Well-conducted randomized trials comparing BK with sham would help resolve remaining uncertainty about the relative benefits and harms of BK. This article is protected by copyright. All rights reserved.