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

ConditionsFractures, Bone Nonunion of Fracture Fractures, Open Fractures, Ununited Fracture, Tibial Fracture of Femur Fracture 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

Locations

OrlandoHealth32806, OrlandoFlorida, United States

RWJBarnabas Health07302, Jersey CityNew Jersey, United States

Duke University Medical Center27710, DurhamNorth Carolina, United States

Sentara Hospitals23507, NorfolkVirginia, United States

Sponsors and collaborators

LifeNet Health

Lead sponsor

Source ClinicalTrials.gov