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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

Who can join

All ages · All sexes

Prospective Cohort 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:

1. Patients unable to understand either an English or Spanish consent will be excluded.
2. Patients unable to consent secondary to dementia and/or other mental/psychiatric diagnoses will be excluded.

About the study

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.

What is being tested

• Vivigen Cellular Bone Matrix (other)

Sponsor: LifeNet Health · Participants: 250 · Started: Jun 1, 2021

Contact the study team

• Monique Alston-Epps · Phone: 757-609-4378
• Kimberly Dorsch · Phone: 757-609-4378

Official record on ClinicalTrials.gov — NCT04299022

Locations in the U.S.

Conditions

• Fractures
• Open Fractures
• Leg Injuries and Disorders

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.