Prospective Evaluation of Therapeutic Combination in Treating Vertebral Compression Fractures

Recruiting

• Conditions: Vertebral Compression Fractures; Pathological Fracture; Facet Joint Arthropathy

• Registration Number: NCT06670404
• Lead Sponsor: Prof Nicolas Theumann

Brief Summary

The purpose of this study is to collect clinical and radiographic outcomes in patients undergoing vertebroplasty procedures for the treatment of osteoporotic or pathological fractures of the vertebral body to understand the role of sagittal balance in patient outcomes. To support this objective, the sagittal balance measurement of sagittal vertical axis (SVA), NRS back pain, Quebec Back Pain Disability Scale (Quebec) score, and complications will be collected. The secondary purpose of the study is to review the role of sagittal balance and adjacent facet joint arthropathy treatment in patients with vertebral body fractures due to osteoporosis or tumor.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-31
• Study First Submitted QC: 2024-10-31
• Study First Posted: 2024-11-01
• Study Start: 2024-11-06
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-17
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement of sagittal balance	Up to 12 months post index surgery	measurement of sagittal vertical axis (SVA)

Secondary Outcome Measures

Name	Time	Method
Improvement in Back Pain	Up to 12 months post index surgery	Measured as NRS scale for back pain
Quebec Score	6-12 months post index surgery	Measured as the standard Quebec Score
Complications	Up to 12 months post-index surgery

Trial Locations

Locations (1)

Clinique Bois Cerf; 🇨🇭 Lausanne, Switzerland