Comparing vertebroplasty to a sham procedure for treating painful osteoporotic fractures
Percutaneous Vertebroplasty Vs. Sham for Osteoporotic Vertebral Compression Fractures Focusing on Pain and Economy: a Single-center, Double-blind Randomized Controlled Clinical Trial
This study is testing whether a procedure called vertebroplasty can help relieve severe pain in people with painful osteoporotic fractures compared to a fake treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Spine Centre of Southern Denmark Academic / other |
| Locations | 1 site (Middelfart, Fyn) |
| Trial ID | NCT06141187 on ClinicalTrials.gov |
What this trial studies
This randomized double-blind clinical trial aims to evaluate the effectiveness of percutaneous vertebroplasty (PVP) in alleviating severe pain in patients with MRI-confirmed acute or sub-acute osteoporotic vertebral compression fractures. Participants will be randomly assigned to receive either the vertebroplasty procedure or a sham operation, with their pain intensity measured on a Visual Analog Scale (VAS) 12 weeks post-treatment. The study will also assess secondary outcomes such as back-related disability, quality of life, and the socio-economic implications of the procedure. Patients will be recruited from the Region of Southern Denmark and will undergo imaging and treatment at the Center for Spine Surgery and Research at Lillebaelt Hospital.
Who should consider this trial
Good fit: Ideal candidates are patients aged 50 and older with symptomatic osteoporotic spinal compression fractures verified by MRI.
Not a fit: Patients with contraindications for spine surgery or those with complete vertebral body collapse may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide significant pain relief and improved quality of life for patients suffering from osteoporotic vertebral compression fractures.
How similar studies have performed: Previous studies have shown mixed results regarding the efficacy of vertebroplasty, making this trial a valuable contribution to the ongoing debate about its effectiveness.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Middelfart, Fyn
- Rygcenter Syddanmark — Middelfart, Fyn, Denmark (Recruiting)
Study contacts
- Principal investigator: Mikkel Ø Andersen, MD — Sygehus Lillebælt
- Study coordinator: Mikkel Ø Andersen, MD
- Email: mikkel.andersen2@rsyd.dk
- Phone: +45 2320 9173
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.