Evaluating treatment outcomes for vertebral compression fractures

PROTECT - Prospective Evaluation of Therapeutic Combination in Treating Vertebral Compression Fractures

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
• Enrollment: 130 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hirslanden Clinique Bois-Cerf Lausanne (other)
• Locations: 1 site (Lausanne)
• Trial ID: NCT06670404 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with symptomatic vertebral compression fractures due to osteoporosis or tumors requiring vertebroplasty.

Not a fit: Patients with severe vertebral body collapse, spinal infections, or unstable spine conditions may not benefit from this study.

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 performed: Other studies have shown promising results with vertebroplasty for similar conditions, indicating a potential for success in this approach.

Eligibility 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 this trial is running

Lausanne

• Clinique Bois Cerf — Lausanne, Switzerland (RECRUITING)

Study contacts

• Study coordinator: Nicolas Prof Theumann, Medical Doctor

Conditions: Vertebral Compression Fractures, Pathological Fracture, Facet Joint Arthropathy, vertebroplasty, CONFIDENCE High Viscosity Spinal Cement, observational post-market study