Status:
RECRUITING
Percutaneous Vertebroplasty Vs. Sham for Osteoporotic Vertebral Compression Fractures Focusing on Pain and Economy.
Lead Sponsor:
Spine Centre of Southern Denmark
Conditions:
Osteoporotic Fractures
Vertebral Fracture
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
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 o...
Detailed Description
The study design is a prospective, double-blind, randomized, sham-controlled clinical trial where patients are stratified into either involvement of 1-2 vertebral levels or 3-4 levels and randomized t...
Eligibility Criteria
Inclusion
- 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
- \- 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.
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT06141187
Start Date
January 1 2024
End Date
December 31 2030
Last Update
January 6 2025
Active Locations (1)
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1
Rygcenter Syddanmark
Middelfart, Fyn, Denmark, 5500