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

BACKGROUND:

Osteoporotic and neoplastic vertebral compression fractures (VCF) are common and painful, threatening quality of life and increasing risk of morbidity and mortality. Balloon kyphoplasty is a percutaneous option for treating painful cancer- and osteoporosis-related VCFs, supported by 2 randomized trials demonstrating efficacy benefits of BKP over nonsurgical care.

OBJECTIVE:

To investigate 12-mo disability, quality of life, and safety outcomes specifically in a Medicare-eligible population, representing characteristic patients seen in routine clinical practice.

METHODS:

A total of 354 patients with painful VCFs were enrolled at 24 US sites with 350 undergoing kyphoplasty. Four coprimary endpoints-Numerical Rating Scale (NRS) back pain, Oswestry Disability Index (ODI), Short Form-36 Questionnaire Physical Component Summary (SF-36v2 PCS), EuroQol-5-Domain (EQ-5D)-were evaluated for statistically significant improvement 3 mo after kyphoplasty. Data were collected at baseline, 7 d, and 1, 3, 6, and 12 mo (www.clinicaltrials.gov registration NCT01871519).

RESULTS:

At the 3-mo primary endpoint, NRS improved from 8.7 to 2.7 and ODI improved from 63.4 to 27.1; SF-36 PCS was 24.2 at baseline improving to 36.6, and EQ-5D improved from 0.383 to 0.746 (P < .001 for each). These outcomes were statistically significant at every follow-up time point. Five device-/procedure-related adverse events, intraoperative asymptomatic balloon rupture, rib pain, and aspiration pneumonia, and a new VCF 25 d postprocedure, and myocardial infarction 105 d postprocedure were reported and each resolved with proper treatment.

CONCLUSION:

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.

• Authors: Douglas P Beall, M R Chambers, Sam Thomas, John Amburgy, James R Webb Jr, Bradly S Goodman, Devin K Datta, Richard W Easton, Douglas Linville 2nd, Sanjay Talati, John B Tillman
• Journal: Neurosurgery (Neurosurgery) Vol. 84 Issue 1 Pg. 169-178 (01 01 2019) ISSN: 1524-4040 [Electronic] United States
• PMID: 29547939 (Publication Type: Clinical Trial, Phase IV, Journal Article, Multicenter Study)

Topics

• Activities of Daily Living
• Aged
• Aged, 80 and over
• Female
• Fractures, Compression (etiology, surgery)
• Humans
• Kyphoplasty (methods)
• Male
• Middle Aged
• Neoplasms (complications)
• Osteoporotic Fractures (surgery)
• Prospective Studies
• Quality of Life
• Spinal Fractures (etiology, surgery)
• Treatment Outcome
• United States