Trials / Recruiting
RecruitingNCT06670404
Prospective Evaluation of Therapeutic Combination in Treating Vertebral Compression Fractures
PROTECT - Prospective Evaluation of Therapeutic Combination in Treating Vertebral Compression Fractures
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 130 (estimated)
- Sponsor
- Prof Nicolas Theumann · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Vertebroplasty | Vertebral compression fractures treated with CONFIDENCE High Viscosity Cement |
Timeline
- Start date
- 2024-11-06
- Primary completion
- 2026-12-31
- Completion
- 2026-12-31
- First posted
- 2024-11-01
- Last updated
- 2025-02-17
Locations
1 site across 1 country: Switzerland
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06670404. Inclusion in this directory is not an endorsement.