Condition: Osteoporotic Fractures · Vertebral Fracture · Sponsor: Spine Centre of Southern Denmark
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.
This description comes directly from the study's public registry record.
Mikkel Ø Andersen, MD · +45 2320 9173 · mikkel.andersen2@rsyd.dk
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| Rygcenter Syddanmark | Middelfart, Fyn, Denmark | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06141187