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Safety, Efficacy, & Use of ViviGen Cellular Bone Matrix Allograft in Orthopaedic Fracture Care

Recruiting
3 recruiting sites
Start: Mar 4, 2020
NCTNCT04299022

This trial is currently recruiting participants

3 locations available for registration

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.

Eligibility

Age Range

N/A - N/A

Gender

All

Healthy Volunteers

Not Accepted

Detailed Criteria

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.

Conditions

Fractures, BoneNonunion of FractureFractures, OpenFractures, UnunitedFracture, TibialFracture of FemurFracture Arm

Interventions

Vivigen Cellular Bone Matrix

Allograft bone matrix

OTHER

Trial Locations

3 locations currently accepting registrations. Choose a recruiting location below to register your interest.

OrlandoHealth

Orlando, Florida, United States

Recruiting

RWJBarnabas Health

Jersey City, New Jersey, United States

Not Yet Recruiting

Duke University Medical Center

Durham, North Carolina, United States

Recruiting

Sentara Hospitals

Norfolk, Virginia, United States

Recruiting

Sponsor Information

Lead Sponsor

LifeNet Health

Type: INDUSTRY