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

Description

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.

Conditions

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

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Study Overview

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Study Details

Study overview

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.

Safety, Efficacy, & Use of ViviGen Cellular Bone Matrix Allograft in Orthopaedic Fracture Care: A Multi-Center Prospective Registry and Retrospective Data Collection Study

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

Condition
Fractures, Bone
Intervention / Treatment

-

Contacts and Locations

Orlando

OrlandoHealth, Orlando, Florida, United States, 32806

Jersey City

RWJBarnabas Health, Jersey City, New Jersey, United States, 07302

Durham

Duke University Medical Center, Durham, North Carolina, United States, 27710

Norfolk

Sentara Hospitals, Norfolk, Virginia, United States, 23507

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

LifeNet Health,

Alyce Jones, Ph.D, STUDY_DIRECTOR, LifeNet Health

Study Record Dates

2026-07-31