Health Trials

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

ConditionsFractures, BoneNonunion of FractureFractures, OpenFractures, UnunitedFracture, TibialFracture of FemurFracture Arm
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorLifeNet Health

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Vivigen Cellular Bone Matrix

Treatment groups

250 Participants
are divided into 2 treatment groups

Sponsors and collaborators

LifeNet Health

Lead sponsor

Source ClinicalTrials.gov