Evaluating treatment outcomes for vertebral compression fractures
Official title: PROTECT - Prospective Evaluation of Therapeutic Combination in Treating Vertebral Compression Fractures
Run by Hirslanden Clinique Bois-Cerf Lausanne · NCT06670404 · Data updated 2026-11-12
This study is testing how well a procedure called vertebroplasty helps adults with osteoporosis-related spine fractures feel better and improve their quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 130 (estimated) |
| Sponsor | Hirslanden Clinique Bois-Cerf Lausanne Academic / other |
| Locations | 1 site (Lausanne) |
| Status | Recruiting |
| Started | November 6, 2024 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | October 21, 2026 |
| Trial ID | NCT06670404 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 with symptomatic vertebral compression fractures due to osteoporosis or tumors requiring vertebroplasty.
✕Probably not a fit
Patients with severe vertebral body collapse, spinal infections, or unstable spine conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to collect clinical and radiographic outcomes from patients undergoing vertebroplasty for osteoporotic or pathological vertebral fractures. It focuses on understanding the role of sagittal balance in patient outcomes by measuring factors such as sagittal vertical axis, back pain levels, and disability scores. The study also seeks to explore the impact of adjacent facet joint arthropathy treatment in these patients. Data will be gathered from patients over 18 years old who meet specific inclusion criteria related to their fractures and osteoporosis diagnosis.
Why it matters
Potential benefit: If successful, this study could improve treatment strategies for patients with vertebral compression fractures, leading to better pain management and functional outcomes.
How similar studies have gone: Other studies have shown promising results with vertebroplasty for similar conditions, indicating a potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients \>18 years. * Patients requiring vertebroplasty for the fixation of symptomatic pathological fractures of the thoracic or lumbar vertebral body resulting from osteoporosis or tumor. * Symptomatic vertebral compression fracture(s) confirmed by MRI with bone marrow oedema on T2/STIR sequences. * Diagnosis of osteoporosis (clinically and confirmed on DXA with quantifiable BMD) or pathological fracture due to tumor * Patients with 1 or more vertebral compression fractures of the thoracic or lumbar spine Note: Patients with a current vertebral compression fracture who also have a previous history of vertebral compression fractures of the thoracic or lumbar spine may be included. Study Specific Inclusion Criterion • Signed informed consent Exclusion Criteria: * Infection * Vertebral body collapse to less than 1/3 (33%) of original height * Vertebral plana (\>90% vertebral body collapse) * Spinal stenosis (retro pulsed fragments). * Unstable spine warranting surgical stabilization * Prophylactic treatment of any vertebrae with vertebroplasty * Irreversible life threating bleeding disorders * End stage kidney disease * Drug dependence (IVDU) * Pregnancy Study Specific Exclusion Criterion: • Unable or unwilling to follow the standard of care prescribed follow-up visits
Where it's running
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Clinique Bois Cerf
Lausanne, Switzerland Recruiting
Study contacts
- Study coordinator: Nicolas Prof Theumann, Medical Doctor
- Email: nicolas.theumann@hirslanden.ch
- Phone: 0041795251859
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Trans-arterial embolization to treat lumbar facet joint pain
This single-site effort will try trans-arterial embolization with Embozene microparticles to see if it reduces lumbar facet (facetogenic) pain in adults with osteoarthritis who have not improved with standard treatments.
-
Registry for the IlluminOss Bone Stabilization Device
This study is collecting information on how well the IlluminOss Bone Stabilization Device works and keeps patients safe after surgery for broken bones.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.