🌐 EnglishEN

AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

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

RecruitingNAAges 50 Years - anyAllSpine Centre of Southern Denmark
NCT06141187 on ClinicalTrials.gov ↗
💬

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

Sign in
📋 Eligibility rules (as published)
Inclusion Criteria: * 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. Exclusion Criteria: * \- 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. * Presence of neurologic deficit. * Contraindications for MRI scanning. * Psychological or psychiatric disorder that is expected to interfere with compliance. * Active malignancy. * Mini Mental State Examination (MMSE) test score below 24. * History of chronic back pain requiring ongoing opiate use. * Systemic or local infection of the spine.
💊

What it tests

  • Vertebroplasty
  • Sham Vertebroplasty
📍

Where

1 site
Rygcenter Syddanmark
Middelfart, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy