A Randomized Trial of Vertebroplasty for Painful Osteoporotic Vertebral Fractures

Buchbinder, Rachelle; Osborne, Richard H.; Ebeling, Peter R.; Wark, John D.; Mitchell, Peter; Wriedt, Chris J; Graves, Stephen; Staples, Margaret; Murphy, Bridie

doi:10.1056/nejmoa0900429

Cited by 1,284 publications

(1,047 citation statements)

References 29 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%

“…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: Introductionmentioning

confidence: 99%

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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“…For example, in the trial by Deviere and colleagues there were concerns that patients could have known the allocation because the copolymer used in the active arm had a distinct smell 55 . In trials on vertebroplasty, a container with cement was opened during placebo procedure to help with blinding 42, 56 .…”

Section: Strategies Used To Maintain Blinding In Interventional Placementioning

confidence: 99%

“…For example, the results of the vertebroplasty trials 42, 56 were criticised because the elements of placebo procedure could have had an effect on the reported pain, namely, a potential pharmacological anaesthesia due to injection of an anaesthetic into the facet capsule and periosteum 57 .…”

Section: Strategies Used To Maintain Blinding In Interventional Placementioning

confidence: 99%

“…Interventional treatment often requires additional procedures, such as diagnostic scans or medication to prevent infection 43, 56, 62 , blood clots 40 , transplant rejection 63 , or epileptic fits 35 . For example, in the trial by Freed and colleagues, both groups received identical preoperative evaluation, intraoperative sedation and pain control, underwent two PET scans and a MRI scan, and received phenytoin 35 .…”

Section: Strategies Used To Maintain Blinding In Interventional Placementioning

confidence: 99%

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Blinding in trials of interventional procedures is possible and worthwhile

2017

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In this paper, we have used evidence from our earlier review of surgical randomised controlled trials with a placebo arm to show that blinding in trials of interventional procedures is feasible, and that many creative methods can be used to make the active and the placebo procedure as similar as possible. We give examples of ingenious strategies used to simulate the active procedure and make the placebo control indistinguishable from the active treatment. We discuss why it is important to blind of patients, assessors, and caregivers and the types of bias that may occur in interventional trials. Finally, we describe the benefits of blinding, from the obvious ones such as avoiding bias, as well as less evident benefits such as avoiding patient drop out in the control arm.

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Reversals of Established Medical Practices

Prasad¹,

Cifu²,

Ioannidis³

2012

JAMA

177

126

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A Randomized Trial of Vertebroplasty for Painful Osteoporotic Vertebral Fractures

Abstract: We found no beneficial effect of vertebroplasty as compared with a sham procedure in patients with painful osteoporotic vertebral fractures, at 1 week or at 1, 3, or 6 months after treatment. (Australian New Zealand Clinical Trials Registry number, ACTRN012605000079640.)

Cited by 1,284 publications

References 29 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

Blinding in trials of interventional procedures is possible and worthwhile

Reversals of Established Medical Practices

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