SAN FRANCISCO — Results of the international, randomized controlled, multi-centered Fracture Reduction Evaluation (FREE) trial indicated that balloon kyphoplasty improved patients’ quality of life and reduced back pain and disability.
The results of the FREE trial, which compared the safety and effectiveness of balloon kyphoplasty, were presented at the 24th Annual Meeting of the North American Spine Society (NASS), here.
“Kyphoplasty is an effective and safe early treatment option for patients with acute vertebral compression fractures,” Douglas Wardlaw, MD, of Woodend Hospital in Aberdeen, U.K., stated in a NASS press release.
The study evaluated 300 patients treated at 21 sites in eight countries. The mean patient age was 73 years and of those patients 78% were women. Most of the injuries in patients with vertebral compression fractures were caused by osteoporosis, according to the study.
The primary study endpoint was quality of life measured by the physical component (PC) of the SF-36 measured at 1 month postoperative. Secondary measures included the SF-36 subscales and summary scales, the Euroquol-5D (EQ-5D) global health measure, a Visual Analog Scale and the Roland Morris Disability Questionnaire.
Patients were randomized to receive kyphoplasty via a percutaneous bilateral approach or nonsurgical treatment based on the standard practices of the individual hospitals.
At 1 month, the SF-36 PC scores had improved 5.1 points more than the scores for the nonsurgical group. At 2-year follow-up, the kyphoplasty patients’ baseline SF-36 PC scores were improved by 3 points.
Wardlaw said that compared to the nonoperative patients the kyphoplasty patients reported statistically significant improvements in quality of life. The EQ-5D scores improved an average of 0.13 points more than the nonoperative patients at 2 years, (P = .004).
“[The] kyphoplasty patients also had significantly less back pain and disability,” Wardlaw noted in the release. “These benefits persisted over 2 years.”