Safety, Efficacy, & Use of ViviGen Cellular Bone Matrix Allograft in Orthopaedic Fracture Care: A Multi-Center Prospective Registry and Retrospective Data Collection Study
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- LifeNet Health
- Enrollment
- 250
- Locations
- 4
- Primary Endpoint
- Reintervention Rate
Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Any skeletally mature patient treated with Vivigen bone graft in the setting of an acute fracture, delayed, non-union or fusion setting will be eligible for inclusion.
- •Retrospective Cohort Inclusion Criteria:
- •Any skeletally mature patient treated with adjunct bone graft in the setting of an acute fracture, delayed, non-union or fusion setting will eligible for inclusion.
- •Prospective Cohort
Exclusion Criteria
- •Patients unable to understand either an English or Spanish consent will be excluded.
- •Patients unable to consent secondary to dementia and/or other mental/psychiatric diagnoses will be excluded.
Outcomes
Primary Outcomes
Reintervention Rate
Time Frame: 24 months
the proportion of patients requiring secondary intervention (return to the operating room) within twelve months after definitive wound closure
Secondary Outcomes
- Patient Reported Outcome Measurement Information System (PROMIS) Scores(24 months)
- Fusion Rate(24 months)