Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open-label randomised trial

Klazen, Caroline A. H.; Lohle, Paul N.M.; Vries, Jolanda De; Jansen, Frits H.; Tielbeek, Alexander V.; Blonk, M. C.; Venmans, A.; Rooij, W. J. J. van; Schoemaker, Marinus C.; Juttmann, J.R.; Lo, T. H.; Verhaar, Harald J. J.; Graaf, Yolanda van der; Everdingen, K.J. van; Müller, Alex F.; Elgersma, Otto E. H.; Halkema, Dirk R.; Fransen, H.; Janssens, X; Buskens, Erik; Mali, Willem P.Th.M.

doi:10.1016/s0140-6736(10)60954-3

Cited by 773 publications

(691 citation statements)

References 26 publications

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“…Further randomized studies are needed to address this issue, although a subsequently published RCT (VERTOS II) found clear superiority of VP versus NSM [41]. The current study represents an updated systematic review of prospective studies of VAP and NSM for the treatment of osteoporotic VCFs.…”

Section: Discussionmentioning

confidence: 91%

“…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%

“…However, this should be interpreted with caution because of significant heterogeneity (I 2 = 99) in pain relief for all three treatment groups. Surprisingly, even between RCTs, great variance exists, for instance in VERTOS II [41] there is almost a double size effect in pain reduction comparing with the INVEST [21] or the Buchbinder trial [22]. This is partially attributable to the non-uniform scales across studies but also points to the unreliability of this method; patient rated VAS pain scores may be referring to maximum pain, average or current pain, or pain with or without medications, positional pain, etc.…”

Section: Pain Reliefmentioning

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: 91%

Section: Analysis Of Pooled Treatment Armsmentioning

confidence: 99%

Section: Pain Reliefmentioning

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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“…However, KP also aims to restore the height of the vertebral bodies. Recently, two randomized controlled trials (RCTs) have indicated that both of the procedures can produce immediate pain relief than conservative treatments [19,47]. In 2011, an RCT with 24 months of follow-up reported that kyphoplasty reduced pain and improved function, disability and quality of life more effectively than nonsurgical therapy without increasing the risk of additional vertebral fractures [8].…”

Section: Introductionmentioning

confidence: 99%

Balloon kyphoplasty versus percutaneous vertebroplasty in treating osteoporotic vertebral compression fracture: grading the evidence through a systematic review and meta-analysis

Xing

et al. 2012

Eur Spine J

114

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Objective To assess the safety and efficacy of balloon kyphoplasty (KP) compared with percutaneous vertebroplasty (VP) and provide recommendations for using these procedures to treat osteoporotic vertebral compression fractures (OVCF). Methods A systematic search of all studies published through March 2012 was conducted using the MEDLINE, EMBASE, OVID, ScienceDirect and Cochrane CENTRAL databases. The randomized controlled trials (RCTs) and non-randomized controlled trials that compared KP to VP and provided data on safety and clinical effects were identified. Demographic characteristics, adverse events and clinical outcomes were manually extracted from all of the selected studies. The evidence quality levels and recommendations were assessed using the GRADE system. Results Twelve studies encompassing 1,081 patients met the inclusion criteria. Subgroup meta-analyses were performed according to the study design. In the RCT subgroup, there were significant differences between the two procedures in short-term visual analog scale (VAS), long-term kyphosis angles, operative times and anterior vertebrae heights. In the cohort study subgroup, there were significant differences between the two procedures in short-and longterm VAS, short-and long-term Oswestry Disability Index (ODI), cement leakage rates, short-and long-term kyphosis angles, operative times and anterior vertebrae heights. However, there were no significant differences in long-term VAS or adjacent vertebral fracture rates in the RCT subgroup. There were no significant differences in short-or long-term VAS, short-or long-term ODI, cement leakage rates, adjacent vertebral fracture rates, short-or long-term kyphosis angles or anterior vertebrae heights in the CCT subgroup, and the adjacent vertebral fracture rates did not differ significantly in the cohort study subgroup. The overall GRADE system evidence quality was very low, which lowers our confidence in their recommendations. Conclusions KP and VP are both safe and effective surgical procedures for treating OVCF. KP may be superior to VP in patients with large kyphosis angles, vertebral fissures, fractures in the posterior edge of the vertebral body or significant height loss in the fractured vertebrae. Due to the poor quality of the evidence currently available, highquality RCTs are required.

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“…Sixteen percent of women after menopause and 20 % of all adults older than age 70 years suffer from vertebral compression fractures [1].The main complication of VCF is acute pain, reported in up to 84 % of patients with radiographic evidence of a compression fracture [2]. Vertebroplasty and kyphoplasty vertebral augmentation procedures have been shown to be more effective than conservative treatment when treating painful vertebral compression fractures [3,4].…”

Section: Introductionmentioning

confidence: 99%

Vertebral Augmentation with Nitinol Endoprosthesis: Clinical Experience in 40 Patients with 1-Year Follow-up

Anselmetti

Manca

Marcia

et al. 2013

Cardiovasc Intervent Radiol

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Purpose This study was designed to assess the clinical outcomes of patients treated by vertebral augmentation with nitinol endoprosthesis (VNE) to treat painful vertebral compression fractures. Methods Forty patients with one or more painful osteoporotic VCF, confirmed by MRI and accompanied by back-pain unresponsive to a minimum 2 months of conservative medical treatment, underwent VNE at 42 levels. Preoperative and postoperative pain measured with Visual Analog Scale (VAS), disability measured by Oswestry Disability Index (ODI), and vertebral height restoration (measured with 2-dimensional reconstruction CT) were compared at last follow-up (average follow-up 15 months). Cement extravasation, subsequent fractures, and implant migration were recorded.Results Long-term follow-up was obtained in 38 of 40 patients. Both VAS and ODI significantly improved from a median of 8.0 (range 5-10) and 66 % (range 44-88 %) to 0.5 (range 0-8) and 6 % (range 6-66 %), respectively, at 1 year (p \ 0.0001). Vertebral height measurements comparing time points increased in a statistically significant manner (ANOVA, p \ 0.001). Overall cement extravasation rate was 9.5 %. Discal and venous leakage rates were 7.1 and 0 % respectively. No symptomatic extravasations occurred. Five of 38 (13.1 %) patients experienced new spontaneous, osteoporotic fractures. No device change or migration was observed. Conclusions VNE is a safe and effective procedure that is able to provide long-lasting pain relief and durable vertebral height gain with a low rate of new fractures and cement leakages.

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Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open-label randomised trial

Abstract: ZonMw; COOK Medical.

Cited by 773 publications

References 26 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

Balloon kyphoplasty versus percutaneous vertebroplasty in treating osteoporotic vertebral compression fracture: grading the evidence through a systematic review and meta-analysis

Vertebral Augmentation with Nitinol Endoprosthesis: Clinical Experience in 40 Patients with 1-Year Follow-up

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