Prospective, single-arm interventional cohort.
To evaluate the safety and effectiveness of balloon kyphoplasty to treat symptomatic vertebral body compression fractures (VCFs).
Summary of Background Data.
VCFs treated nonoperatively can diminish function and quality of life, and lead to chronic health effects. The short-term safety and effectiveness of balloon kyphoplasty for symptomatic VCFs are well-documented, but long-term follow-up is needed.
A total of 155 elderly patients with symptomatic VCFs were enrolled in a prospective, multicenter treatment study of balloon kyphoplasty at 19 geographically diverse US centers. Outcomes included back pain severity, bedrest, and limited activities because of back pain, back disability score, and SF-36 Medical Outcomes Survey, at 7 days (visual analog scale only), and 1, 3, 12, and 24 months after treatment.
Patients reported severe back pain (15/20 on visual analog scale) interfering with daily activities 90% of days per month before kyphoplasty. Physical functioning and quality of life were also markedly impaired. Statistically significant (P < 0.001) improvements occurred in all pain, functional, and mental health outcomes at the first follow-up after treatment and were maintained for 24 months.
Elderly patients with symptomatic VCFs had rapid, significant, and sustained improvements in back pain, back function, and quality of life following balloon kyphoplasty.