Percutaneous Vertebroplasty Vs. Sham for Osteoporotic Vertebral Compression Fractures Focusing on Pain and Economy.
Percutaneous Vertebroplasty Vs. Sham for Osteoporotic Vertebral Compression Fractures Focusing on Pain and Economy: a Single-center, Double-blind Randomized Controlled Clinical Trial
Spine Centre of Southern Denmark
240 participants
Jan 1, 2024
INTERVENTIONAL
Conditions
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 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.
Eligibility
Inclusion Criteria10
- 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 Criteria11
- \- 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.
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Interventions
PVP
Sham PVP
Locations(1)
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NCT06141187