Vertebral Augmentation for Osteoporotic Compression Fractures: Review of the Fracture Reduction Evaluation Trial.

Osteoporotic vertebral compression fractures affect more than 1 million patients worldwide each year. Percutaneous balloon kyphoplasty is a minimally invasive vertebral augmentation procedure that aims to stabilize fractured vertebral compression fractures rapidly and improve spinal deformity. The Fracture Reduction Evaluation (FREE) trial was the first randomized trial to compare balloon kyphoplasty against nonoperative management and it remains a landmark trial today. On the basis of this single trial, the American Academy of Orthopaedic Surgeons made a "weak" recommendation that "kyphoplasty is an option" for patients presenting with osteoporotic vertebral compression fractures. Ongoing controversy remains about the effectiveness of this technique compared with placebo or sham surgery and other vertebral augmentation procedures. Economic analyses suggest that kyphoplasty is cost-effective, but complication rates and long-term outcomes remain poorly defined.

RCT Entities:   Population Interventions Outcomes