Prospective and Multicenter Evaluation of Outcomes for Quality of Life and Activities of Daily Living for Balloon Kyphoplasty in the Treatment of Vertebral Compression Fractures: The EVOLVE Trial

Beall, Douglas P.; Chambers, M. R.; Thomas, Sam; Amburgy, John; Webb, James R.; Goodman, Bradly S.; Datta, Devin; Easton, Richard; Linville, Douglas A.; Talati, Sanjay J.; Tillman, John B.

doi:10.1093/neuros/nyy017

Cited by 52 publications

(31 citation statements)

References 31 publications

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“…We were unable to include findings from a recently completed prospective, multicenter evaluation of the safety and efficacy of BKP in Medicare patients (EVOLVE trial 61 ), as it had not yet been published in a peer-reviewed journal. The results of this EVOLVE trial included statistically significant improvements in patients' pain, function, quality of life, self-care indices, and vertebral deformity correction.…”

Section: Resultsmentioning

confidence: 99%

Review of Vertebral Augmentation: An Updated Meta-analysis of the Effectiveness

Beall¹,

Lorio

Yun

et al. 2018

Int J Spine Surg

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Background: To update vertebral augmentation literature by comparing outcomes between vertebroplasty (VP), balloon kyphoplasty (BKP), vertebral augmentation with implant (VAI), and nonsurgical management (NSM) for treating vertebral compression fractures (VCFs).Methods: A PubMed literature search was conducted with keywords kyphoplasty, vertebroplasty, vertebral body stent, and vertebral augmentation AND implant for English-language articles from February 1, 2011, to November 22, 2016. Among the results, 25 met the inclusion criteria for the meta-analysis. Inclusion criteria were prospective comparative studies for mid-/lower-thoracic and lumbar VCFs enrolling at least 20 patients. Exclusion criteria included studies that were single arm, systematic reviews and meta-analyses, traumatic nonosteoporotic or cancer-related fractures, lack of clinical outcomes, or non-Level I and non-Level II studies. Standardized mean difference between baseline and end point for each outcome was calculated, and treatment groups were pooled using random effects meta-analysis.Results: Visual analog scale pain reduction for BKP and VP was À4.05 and À3.88, respectively. VP was better than but not significantly different from NSM (À2.66), yet BKP showed significant improvement from both NSM and VAI (À2.77). The Oswestry Disability Index reduction for BKP showed a significant improvement over VAI (P , .001). There was no significant difference in changes between BKP and VP for anterior (P ¼ .226) and posterior (P ¼ .293) vertebral height restoration. There was no significant difference in subsequent fractures following BKP (32.7%; 95% confidence interval [CI]: 8.8%-56.6%) or VP (28.3%; 95% CI: 7.0%-49.7%) compared with NSM (15.9%; 95% CI: 5.2%-26.6%).Conclusions/Level of Evidence: Based on Level I and II studies, BKP had significantly better and VP tended to have better pain reduction compared with NSM. BKP tended to have better height restoration than VP. Additionally, BKP had significant improvements in pain reduction and disability score as compared with VAI.Clinical Relevance: This meta-analysis serves to further define and support the safety and efficacy of vertebral augmentation.

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Section: Resultsmentioning

confidence: 99%

Review of Vertebral Augmentation: An Updated Meta-analysis of the Effectiveness

Beall¹,

Lorio

Yun

et al. 2018

Int J Spine Surg

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“…Reduction in duration of hospitalization providing probable cost savings in favor of vertebroplasty. Beall et al 47 2018…”

Section: Authorsmentioning

confidence: 99%

“…For kyphoplasty, there has been 1 RCT (the FREE trial) 59 and 1 postmarket trial (the EVOLVE trial) 47 clearly demonstrating the benefit of this treatment. Indeed, the FREE trial evaluated 300 patients (149 treated by balloon kyphoplasty and 151 with optimal pain management).…”

Section: Studies Published After 2009: Kyphoplastymentioning

confidence: 99%

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ISASS Policy 2018—Vertebral Augmentation: Coverage Indications, Limitations, and/or Medical Necessity

Clerk-Lamalice¹,

Beall²,

Ong

et al. 2019

Int J Spine Surg

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The ISASS Policy Statement on vertebral augmentation has the objectives to provide a background and an update with the latest clinical evidence for the international spine community. A SpineLine Panel Review (2010) appropriately recommended an exploration of ''the seeming disconnect between the conclusions of . . . two [Level I] PRCT's and previous experience and data'' regarding vertebral augmentation. ISASS responded by supporting a comprehensive meta-analysis to help frame a cogent historical analysis of vertebral augmentation. This ISASS Policy 2018 is based on a thorough literature search for relevant studies, including systematic reviews and meta-analyses, that are subjected to thorough quality appraisal for the purpose of informing public opinion and decision making. Given the abundance of high-quality information, ISASS can confidently advocate that there is strong support for vertebral augmentation in the treatment of symptomatic vertebral compression fractures.Testing & Regulatory Affairs

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“…63 Recent evidence suggests that kyphoplasty is safe and effective in the management of both osteoporotic and neoplastic vertebral compression fractures. 62,[64][65][66][67] However, the most recent 2016 Cardiovascular and Interventional Radiological Society of Europe guidelines on percutaneous vertebral augmentation 48 found "no strong evidence for recommending" kyphoplasty over vertebroplasty in the routine setting, except in certain cases where height restoration is of paramount importance.…”

Section: Kyphoplastymentioning

confidence: 99%

Therapeutic Intervention in Musculoskeletal Radiology: Current Practice and Future Directions

Walsh

Farrell

Hynes

et al. 2018

Semin Musculoskelet Radiol

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Over the last several decades, the volume and range of therapeutic musculoskeletal (MSK) interventions that radiologists can offer their patients has dramatically increased. With new materials and improving imaging modalities, as well as significant investment in research, the field of MSK interventional radiologic intervention will likely continue to expand. In this article, we summarize the range of interventions currently available to the MSK radiologist. We also seek to explore new and emerging techniques that may become commonplace in the near future while considering the challenges that may lie ahead in the field of MSK radiology.

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Prospective and Multicenter Evaluation of Outcomes for Quality of Life and Activities of Daily Living for Balloon Kyphoplasty in the Treatment of Vertebral Compression Fractures: The EVOLVE Trial

Abstract: This large, prospective, clinical study demonstrates that kyphoplasty is a safe, effective, and durable procedure for treating patients with painful VCF due to osteoporosis or cancer.

Cited by 52 publications

References 31 publications

Review of Vertebral Augmentation: An Updated Meta-analysis of the Effectiveness

Review of Vertebral Augmentation: An Updated Meta-analysis of the Effectiveness

ISASS Policy 2018—Vertebral Augmentation: Coverage Indications, Limitations, and/or Medical Necessity

Therapeutic Intervention in Musculoskeletal Radiology: Current Practice and Future Directions

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