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

Abstract

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 randomized and quasi-randomized controlled trials comparing BK with control treatment (nonsurgical management [NSM], percutaneous vertebroplasty [PV], KIVA VCF treatment system [Benvenue Medical, Inc., Santa Clara, CA, USA], vertebral body stenting, or other) in adults with VCF. Outcomes included back pain, back disability, quality of life, new VCF, and adverse events (AEs). One reviewer extracted data, a second checked accuracy, and two rated risk of bias (ROB). Mean differences and 95% confidence intervals (CIs) were calculated using inverse-variance models. Risk ratios of new VCF and AE were calculated using Mantel-Haenszel models. Ten unique trials enrolled 1837 participants (age range, 61 to 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 quality of life (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; 95% CI, 1.36 to 2.21). There were no significant differences between BK and PV in back pain, back disability, quality of life, 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. © 2017 American Society for Bone and Mineral Research.

The Efficacy and Safety of Vertebral Augmentation: A Second ASBMR Task Force Report

“…This report details the findings and recommendations of this Task Force. The work of this report builds upon that of a related ASBMR Task Force Report published in 2017 that addressed pain, quality of life, and safety outcomes associated with kyphoplasty for vertebral fractures, which is summarized in detail in Section 2, Balloon Kyphoplasty, below …”

Health Related Quality of Life in Patients with Osteoporotic Vertebral Fracture

“…Several studies reported health-related QOL (HRQOL) of VCF patients because VCF could affect their HRQOL. Some studies used HRQOL as indicators by interventions such as a VP [9] or a KP [10]. The European QOL-5 dimensions, 3-level version (EQ-5D-3L) is a well-know and widely used HRQOL instrument among general instruments [11] and this instrument is also used to measure HRQOL of VCF patients widely [9,12,13].…”

Kyphoplasty Restores the Global Sagittal Balance of the Spine Independently from Pain Reduction

“…The efficacy of kyphoplasty for short-term pain relief is well documented and widely accepted 6,7 . However, the advantage of kyphoplasty over conservative therapy regarding pain relief seems to diminish over time 8 . Additionally, there is so far no study comparing the pain relief of kyphoplasty to the placebo-effect of a sham procedure 8 .…”

“…However, the advantage of kyphoplasty over conservative therapy regarding pain relief seems to diminish over time 8 . Additionally, there is so far no study comparing the pain relief of kyphoplasty to the placebo-effect of a sham procedure 8 . Therefore, the key factors for the evaluation of the long-term benefit/risk ratio of kyphoplasty seem to be the restoration of lost vertebral body height and the correction of fracture-related spinal malposition.…”