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.
- Contra-indications for spine surgery.
Platelets < 30 mia/l.
Osteoporotic Fractures type 5 and Pincer-type.
Complete collapse of the vertebral body precluding insertion of needle.