Percutaneous Vertebroplasty Vs. Sham for Osteoporotic Vertebral Compression Fractures Focusing on Pain and Economy: a Single-center, Double-blind Randomized Controlled Clinical Trial
The purpose of this randomized double-blind clinical trial is to determine the efficacy of percutaneous vertebroplasty (PVP) in relieving severe pain in patients with MRI-verified acute or sub-acute osteoporotic vertebral compression fractures (OVCFs) compared to sham as well as examine the socio-economic implications associated with performing vertebroplasty. The primary outcome is improvement of pain intensity as measured on a Visual Analog Scale (VAS, 0 to100) 12 weeks after treatment. Secondary outcomes include patient-reported back-related disability, patient-reported quality of life, spinal sagittal balance, complications associated with the procedure, incidence of new OVCFs and socioeconomic costs.
• Patients aged 50+ and diagnosed with symptomatic osteoporotic spinal compression fractures between T6 and L5 (incl).
• Focal tenderness on the level of the vertebral fracture.
• Fractures verified with oedema of the relevant vertebra on the MRI STIR sequence
• Osteoporotic Fractures type 1-4.
• Fracture involves no more than 4 vertebral body levels.
• PVP can be done in one session.
• Back pain score measured on a Visual Analog Scale (VAS, 0 to 100) ≥ 60.
• Able to understand and read Danish.
• Written informed consent.
• Relevant pain started ≤ 3 months prior to enrollment.