Trials / Recruiting
RecruitingNCT04299022
Safety, Efficacy, & Use of ViviGen Cellular Bone Matrix Allograft in Orthopaedic Fracture Care
Safety, Efficacy, & Use of ViviGen Cellular Bone Matrix Allograft in Orthopaedic Fracture Care: A Multi-Center Prospective Registry and Retrospective Data Collection Study
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 250 (estimated)
- Sponsor
- LifeNet Health · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
Prospective registry and retrospective data collection study to assess the efficacy and safety of Vivigen Cellular Bone Matrix (Vivigen) in orthopaedic trauma patients who require bone grafting in the acute, delayed, non-union fracture as well as use in fusion procedure settings.
Detailed description
The prospective registry study and retrospective data collection study is planned to assess the efficacy and safety of Vivigen Cellular Bone Matrix (Vivigen) in orthopaedic trauma patients who require bone grafting in the acute, delayed, non-union fracture as well as use in fusion procedure settings. Patients will be assessed at hospital discharge, 6 weeks, 3 months, 6 months, 12 months and 24 months after treatment of a traumatic fracture with a bone graft.
Conditions
- Fractures, Bone
- Nonunion of Fracture
- Fractures, Open
- Fractures, Ununited
- Fracture, Tibial
- Fracture of Femur
- Fracture Arm
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Vivigen Cellular Bone Matrix | Allograft bone matrix |
Timeline
- Start date
- 2021-06-01
- Primary completion
- 2026-07-31
- Completion
- 2026-07-31
- First posted
- 2020-03-06
- Last updated
- 2025-04-02
Locations
4 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT04299022. Inclusion in this directory is not an endorsement.