Comparing vertebroplasty to a sham procedure for treating painful osteoporotic fractures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.