Percutaneous Vertebroplasty Versus Sham for Osteoporotic Vertebral Compression Fractures Focusing on Pain Relief and Economic Impact in a Double-Blind Randomized Trial

What this Trial Is About

Researchers are evaluating the effectiveness of percutaneous vertebroplasty (PVP) compared to a sham procedure in relieving severe pain for patients with acute or sub-acute osteoporotic vertebral compression fractures (OVCFs) confirmed by MRI. This randomized, double-blind clinical trial also examines the socio-economic impact associated with vertebroplasty. The primary goal is to measure pain improvement 12 weeks after treatment, along with secondary outcomes like back-related disability, quality of life, spinal balance, complications, new fractures, and costs. Participants are assigned to one of two groups based on the number of vertebral levels affected (1-2 or 3-4) and then randomized to receive either the vertebroplasty procedure or a sham operation. Experienced spine surgeons perform the treatments while anesthesiologists and surgeons monitor for complications. The study follows strict guidelines to ensure blinding of patients and assessors, with only the surgeon and operating room nurse aware of the assigned treatment. Data on surgery, hospital stay, and follow-up visits are collected throughout. Participants will visit the clinic for evaluations at 4, 12, and 52 weeks after treatment, including MRI and X-rays at 12 weeks to assess healing and new fractures. Pain intensity is recorded multiple times from the day of randomization up to 24 months using a visual scale. Researchers also track healthcare use and any complications. Overall, the study monitors patients for up to two years to understand the treatment's impact on pain relief and related outcomes.

Percutaneous Vertebroplasty Vs. Sham for Osteoporotic Vertebral Compression Fractures Focusing on Pain and Economy.