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

Study acronym: VOPE2
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Study description revisedv3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06141187
Lead Sponsor Spine Centre of Southern Denmark
Conditions
(from sponsor)		 Osteoporotic Fractures, Vertebral Fracture
Related terms Osteoporotic Fractures, Pain, Spinal Fractures
Enrollment 240 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov