Status:
RECRUITING
Safety, Efficacy, & Use of ViviGen Cellular Bone Matrix Allograft in Orthopaedic Fracture Care
Lead Sponsor:
LifeNet Health
Conditions:
Fractures, Bone
Nonunion of Fracture
Eligibility:
All Genders
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...
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...
Eligibility Criteria
Inclusion
- Prospective Cohort
- 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
- \- 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
- 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.
Key Trial Info
Start Date :
June 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 31 2026
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT04299022
Start Date
June 1 2021
End Date
July 31 2026
Last Update
April 2 2025
Active Locations (4)
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1
OrlandoHealth
Orlando, Florida, United States, 32806
2
RWJBarnabas Health
Jersey City, New Jersey, United States, 07302
3
Duke University Medical Center
Durham, North Carolina, United States, 27710
4
Sentara Hospitals
Norfolk, Virginia, United States, 23507