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.
Parallel
Vertebroplasty
Procedure/SurgeryPVP
Sham Vertebroplasty
Procedure/SurgerySham PVP
Pain intensity using the 100-point VAS
Self-reported average pain intensity over the previous 24 hours, using the 100-point VAS will be recorded at time of randomization and after 1, 2, 3, 4 and 5 days, and after 2, 4, 8 and 12 weeks, and finally at 12 months and 24 months post-randomization
Patient-reported disability.
The patients rate their disability at the time of enrolment and at 4 and 12 weeks, 12 and 24 months post-randomization using the Oswestry Disability Index (ODI) questionnaire
Health-related quality of life.
HRQL on the EuroQol 5-dimension 5-level (EQ-5D-5L)
Global Perceived Effect scale
Global perceived effect of the treatment will be assessed using single question with seven-point descriptive scaling with the answers
Sagittal balance
Full-length 36" lateral scoliosis radiographs taken with hands placed on the clavicles will be obtained to measure Pelvic Incidence, Pelvic Tilt, Sacral Slope, C7-Plumb Line and Lumbar Lordosis/Thoracic Kyphosis both preoperatively and after 12 months
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