Trials / Active Not Recruiting
Active Not RecruitingNCT06270173
Post-Market Study of The Tripod-Fix Vertebral Body Augmentation System in Osteoporotic Vertebral Compression Fractures
A Prospective, Multicenter, Open-Label, Post-Market Study to Evaluate The Effectiveness and Safety of The Tripod-Fix Vertebral Body Augmentation System in Osteoporotic Vertebral Compression Fractures Treatment
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 53 (actual)
- Sponsor
- Wiltrom Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this Post-Market Clinical Follow-Up Study is to evaluate the safety and performance of the Tripod-Fix in the treatment of vertebral compression fractures (VCF) resulting from osteoporosis.
Detailed description
This study is a prospective, multicenter, open-label, single-arm, PMCF study. The sample size for this study will be 50 patients. Eligible patients will be treated with Tripod-Fix on Day 0 and will be followed for a total of 12 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Tripod-Fix Vertebral Body Augmentation System (Tripod-Fix) | The Tripod-Fix is a permanent implant used for vertebral augmentation in patients with osteoporotic vertebral compression fractures. |
Timeline
- Start date
- 2024-02-16
- Primary completion
- 2025-12-31
- Completion
- 2026-02-28
- First posted
- 2024-02-21
- Last updated
- 2025-01-22
Locations
4 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT06270173. Inclusion in this directory is not an endorsement.