Percutaneous Vertebroplasty Compared to Conservative Treatment in Patients With Painful Acute or Subacute Osteoporotic Vertebral Fractures

Rousing, Rikke; Andersen, Mikkel; Jespersen, Stig; Thomsen, Karsten; Lauritsen, Jens

doi:10.1097/brs.0b013e3181a4e628

Cited by 203 publications

(204 citation statements)

References 17 publications

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“…Traditionally, VP has been accepted as a successful procedure for treating VCFs; but three recently published RCTs comparing VP with a sham procedure [21,22] or NSM [20] have created contention about the efficacy of VP. Potential flaws confounding the outcomes have been previously outlined: these include low accrual rates at busy centers, inclusion of patients with subacute/chronic fractures, sham design, and no reported clinical examination to determine the source of pain [23].…”

Section: Discussionmentioning

confidence: 99%

“…These studies do not report on what happened to the majority of patients that fulfilled the inclusion criteria but opted not to participate in the study. Non-uniform evaluation of fractures with MRI [20,21], higher crossover rates in the NSM arm [21] and other pain generators unrelated to the fracture (e.g., discogenic/facetogenic pain) are additional problems. Most of the limitations of those RCTs were presented by Bono et al [23] on behalf of the North American Spine Society, and were responded to by study authors [42].…”

Section: Discussionmentioning

confidence: 99%

“…Included Articles N=27 of the studies reported effects for the same group of patients and were combined into one analyzable ''study'' (Kasperk/Grafe et al, 4 total [11,12,24,25] and Rousing et al, 2 total [20,26]; see Table 1). This systematic review was reported in accordance with the PRISMA statement [27].…”

Section: Bkp Vs Nsm N=6mentioning

confidence: 99%

“…Here, we report the comparison between RCTs-only. Seven randomized trials were recognized: one between BKP/VP (Liu [40]), one comparing BKP to NSM (Wardlaw [8]) and five comparing VP either to NSM (Rousing [20], Voormolen [9], Klazen [41]) or to SHAM procedure (Buchbinder [22], Kallmes [21]). In terms of disability reduction, there was no difference between BKP/VP (P = 0.16) or VP/NSM (P = 0.1), with BKP showing a trend toward greater improvement than conservative management (P = 0.078).…”

Section: Analysis Of Pooled Treatment Armsmentioning

confidence: 99%

“…There is class I evidence to support the superiority of vertebral augmentation procedures (VAPs) over NSM [8][9][10], as well as non-randomized prospective studies [11][12][13], systematic reviews [14][15][16][17][18][19], and numerous retrospective series supporting safety and effectiveness of these procedures. However, recently published randomized controlled trials (RCTs) that showed no superiority of VP over NSM [20] or over a simulated procedure (sham) [21,22] have raised questions regarding the value of VP. These trials have been criticized for potential methodological flaws confounding the outcomes [23].…”

Section: Introductionmentioning

confidence: 99%

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Comparing effects of kyphoplasty, vertebroplasty, and non-surgical management in a systematic review of randomized and non-randomized controlled studies

et al. 2012

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Purpose To determine if differences in safety or efficacy exist between balloon kyphoplasty (BKP), vertebroplasty (VP) and non-surgical management (NSM) for the treatment of osteoporotic vertebral compression fractures (VCFs). Methods As of February 1, 2011, a PubMed search (key words: kyphoplasty, vertebroplasty) resulted in 1,587 articles out of which 27 met basic selection criteria (prospective multiple-arm studies with cohorts of C20 patients).This systematic review adheres to preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines.Results Pain reduction in both BKP (-5.07/10 points, P \ 0.01) and VP (-4.55/10, P \ 0.01) was superior to that for NSM (-2.17/10), while no difference was found between BKP/VP (P = 0.35). Subsequent fractures occurred more frequently in the NSM group (22 %) compared with VP (11 %, P = 0.04) and BKP (11 %, P = 0.01). BKP resulted in greater kyphosis reduction than VP (4.88 vs. 1.7°, P \ 0.01). Quality of life (QOL) improvement showed superiority of BKP over VP (P = 0.04), along with a trend for disability improvement (P = 0.08). Cement extravasation was less frequent in the BKP (P = 0.01). Surgical intervention within the first 7 weeks yielded greater pain reduction than VCFs treated later. Conclusions BKP/VP provided greater pain relief and fewer subsequent fractures than NSM in osteoporotic VCFs. BKP is marginally favored over VP in disability improvement, and significantly favored in QOL improvement. BKP had a lower risk of cement extravasation and resulted in greater kyphosis correction. Despite this analysis being restricted to Level I and II studies, significant heterogeneity suggests that the current literature is delivering inconsistent messages and further trials are needed to delineate confounding variables.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Bkp Vs Nsm N=6mentioning

confidence: 99%

Section: Analysis Of Pooled Treatment Armsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Comparing effects of kyphoplasty, vertebroplasty, and non-surgical management in a systematic review of randomized and non-randomized controlled studies

et al. 2012

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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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Percutaneous Vertebroplasty Compared to Conservative Treatment in Patients With Painful Acute or Subacute Osteoporotic Vertebral Fractures

Abstract: The majority of patients with acute or subacute painful osteoporotic compression fractures in the spine will recover after a few months of conservative treatment. The risk of adjacent fractures needs further research. No major adverse events were observed.

Cited by 203 publications

References 17 publications

Comparing effects of kyphoplasty, vertebroplasty, and non-surgical management in a systematic review of randomized and non-randomized controlled studies

Comparing effects of kyphoplasty, vertebroplasty, and non-surgical management in a systematic review of randomized and non-randomized controlled studies

Placebo Control and Blinding in Randomized Trials of Procedural Interventions

Percutaneous vertebroplasty for osteoporotic vertebral compression fracture

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