Randomized controlled trial of percutaneous vertebroplasty versus optimal medical management for the relief of pain and disability in acute osteoporotic vertebral compression fractures

Farrokhi, Majid Reza; Alibai, Ehsanali; Maghami, Zohre

doi:10.3171/2010.12.spine10286

Cited by 238 publications

(263 citation statements)

References 24 publications

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“…However, since the publication of those RCTs and guidelines, several other trials have been published with contrary conclusions. (2)(3)(4)(5) Although the authors of the current study rarely perform vertebroplasty or kyphoplasty, we have noted that in select severely disabled patients, excellent pain relief and rapid return to function result after vertebroplasty. Juxtaposing these observations to the results of RCTs published in 2009 prompted our interest in performing an unbiased systematic review and meta-analysis.…”

Section: Introductionmentioning

confidence: 66%

“…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) …”

Section: Meta-analysis Methodsmentioning

confidence: 99%

“…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.…”

Section: Meta-analysis Methodsmentioning

confidence: 99%

“…(1) The Voormolen and colleagues and Farrokhi and colleagues studies were both downgraded for lack of power analysis. (4,10) The Rousing study was eliminated from the efficacy analysis because baseline data were missing but was included in adverse events assessment.…”

Section: Systematic Reviewmentioning

confidence: 99%

“…(1,2) The Farrokhi and colleagues study used a translator for some of the English-based patient outcome measures; thus, this contribution to the risk of bias remains unclear. (4) The Wardlaw and colleagues study had less stringent inclusion criteria and was funded by the Medtronic Spine LLC. (3) The quality of this systematic review and meta-analysis was rated as 25 of 27 using PRISMA criteria.…”

Section: Systematic Reviewmentioning

confidence: 99%

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

Anderson

Froyshteter

Tontz

2012

Journal of Bone and Mineral Research

178

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Cement augmentation is a controversial treatment for painful vertebral compression fractures (VCF). Our research questions for the meta-analysis were: Is there a clinical and statistical difference in pain relief, functional improvement, and quality of life between conservative care and cement augmentation for VCF and, if so, are they maintained at longer time points? We conducted a search of MEDLINE from January 1980 to July 2011 using PubMed, Cochrane Database of Systematic Reviews and Controlled Trials, CINAHL, and EMBASE. Searches were performed from Medical Subject Headings. Terms ''vertebroplasty'' and ''compression fracture'' were used. The outcome variables of pain, functional measures, health-related quality of life (HRQOL), and new fracture risk were analyzed. A random effects model was chosen. Continuous variables were calculated using the standardized mean difference comparing improvement from baseline of the experimental group with the control group. New vertebral fracture risk was calculated using log odds ratio. Six studies met the criteria. The pain visual analog scale (VAS) mean difference was 0.73 (confidence interval [CI] 0.35, 1.10) for early (<12 weeks) and 0.58 (CI 0.19, 0.97) for late time points (6 to 12 months), favoring vertebroplasty (p < 0.001). The functional outcomes at early and late time points were statistically significant with 1.08 (CI 0.33, 1.82) and 1.16 (CI 0.14, 2.18), respectively. The HRQOL showed superior results of vertebroplasty compared with conservative care at early and late time points of 0.39 (CI 0.16, 0.62) and 0.33 (CI 0.16, 0.51), respectively. Secondary fractures were not statistically different between the groups, 0.065 (CI À0.57, 0.70). This meta-analysis showed greater pain relief, functional recovery, and health-related quality of life with cement augmentation compared with controls. Cement augmentation results were significant in the early (<12 weeks) and the late time points (6 to 12 months). This meta-analysis provides strong evidence in favor of cement augmentation in the treatment of symptomatic

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Section: Introductionmentioning

confidence: 66%

Section: Meta-analysis Methodsmentioning

confidence: 99%

Section: Meta-analysis Methodsmentioning

confidence: 99%

Section: Systematic Reviewmentioning

confidence: 99%

Section: Systematic Reviewmentioning

confidence: 99%

See 3 more Smart Citations

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

Anderson

Froyshteter

Tontz

2012

Journal of Bone and Mineral Research

178

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Placebo Control and Blinding in Randomized Trials of Procedural Interventions

Rajkumar,

Thomas,

Foley

et al. 2024

JAMA Surg

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ImportanceUnlike medications, procedural interventions are rarely trialed against placebo prior to becoming accepted in clinical practice. When placebo-controlled trials are eventually conducted, procedural interventions may be less effective than previously believed.ObjectiveTo investigate the importance of including a placebo arm in trials of surgical and interventional procedures by comparing effect sizes from trials of the same procedure that do and do not include a placebo arm.Data SourcesSearches of MEDLINE and Embase identified all placebo-controlled trials for procedural interventions in any specialty of medicine and surgery from inception to March 31, 2019. A secondary search identified randomized clinical trials assessing the same intervention, condition, and end point but without a placebo arm for paired comparison.Study SelectionPlacebo-controlled trials of anatomically site-specific procedures requiring skin incision or endoscopic techniques were eligible for inclusion; these were then matched to trials without placebo control that fell within prespecified limits of heterogeneity.Data Extraction and SynthesisRandom-effects meta-regression, with placebo and blinding as a fixed effect and intervention and end point grouping as random effects, was used to calculate the impact of placebo control for each end point. Data were analyzed from March 2019 to March 2020.Main Outcomes and MeasuresEnd points were examined in prespecified subgroups: patient-reported or health care professional–assessed outcomes, quality of life, pain, blood pressure, exercise-related outcomes, recurrent bleeding, and all-cause mortality.ResultsNinety-seven end points were matched from 72 blinded, placebo-controlled trials (hereafter, blinded) and 55 unblinded trials without placebo control (hereafter, unblinded), including 111 500 individual patient end points. Unblinded trials had larger standardized effect sizes than blinded trials for exercise-related outcomes (standardized mean difference [SMD], 0.59; 95% CI, 0.29 to 0.89; P &lt; .001) and quality-of-life (SMD, 0.32; 95% CI, 0.11 to 0.53; P = .003) and health care professional–assessed end points (SMD, 0.40; 95% CI, 0.18 to 0.61; P &lt; .001). The placebo effect accounted for 88.1%, 55.2%, and 61.3% of the observed unblinded effect size for these end points, respectively. There was no significant difference between unblinded and blinded trials for patient-reported end points (SMD, 0.31; 95% CI, −0.02 to 0.64; P = .07), blood pressure (SMD, 0.26; 95% CI, −0.10 to 0.62; P = .15), all-cause mortality (odds ratio [OR], 0.23; 95% CI, −0.26 to 0.72; P = .36), pain (SMD, 0.03; 95% CI, −0.52 to 0.57; P = .91), or recurrent bleeding events (OR, −0.12; 95% CI, −1.11 to 0.88; P = .88).Conclusions and RelevanceThe magnitude of the placebo effect found in this systematic review and meta-regression was dependent on the end point. Placebo control in trials of procedural interventions had the greatest impact on exercise-related, quality-of-life, and health care professional–assessed end points. Randomized clinical trials of procedural interventions may consider placebo control accordingly.

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Percutaneous vertebroplasty for osteoporotic vertebral compression fracture

Buchbinder

Golmohammadi

Johnston

et al. 2015

Cochrane Database of Systematic Reviews

155

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Based upon moderate quality evidence, our review does not support a role for vertebroplasty for treating osteoporotic vertebral fractures in routine practice. We found no demonstrable clinically important benefits compared with a sham procedure and subgroup analyses indicated that results did not differ according to duration of pain ≤ 6 weeks versus > 6 weeks. Sensitivity analyses confirmed that open trials comparing vertebroplasty with usual care are likely to have overestimated any benefit of vertebroplasty. Correcting for these biases would likely drive any benefits observed with vertebroplasty towards the null, in keeping with findings from the placebo-controlled trials.Numerous serious adverse events have been observed following vertebroplasty. However due to the small number of events, we cannot be certain about whether or not vertebroplasty results in a clinically important increased risk of new symptomatic vertebral fractures and/or other serious adverse events. Patients should be informed about both the lack of high quality evidence supporting benefit of vertebroplasty and its potential for harm.

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Randomized controlled trial of percutaneous vertebroplasty versus optimal medical management for the relief of pain and disability in acute osteoporotic vertebral compression fractures

Cited by 238 publications

References 24 publications

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

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

Placebo Control and Blinding in Randomized Trials of Procedural Interventions

Percutaneous vertebroplasty for osteoporotic vertebral compression fracture

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