Recruiting

ViviGen

Sponsor:

LifeNet Health

Code:

NCT04299022

Conditions

Fractures, Bone

Nonunion of Fracture

Fractures, Open

Fractures, Ununited

Fracture, Tibial

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Vivigen Cellular Bone Matrix

Study Details

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.

Conditions

Fractures, Bone

Nonunion of Fracture

Fractures, Open

Fractures, Ununited

Fracture, Tibial

Study ID

NCT04299022

Start date

Jun 1, 2021

Status verified date

Mar, 2025

Completion date

Jul 31, 2026

Anticipated

Primary completion date

Jul 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

250 participants

Anticipated

Interventions and Outcome Measures

Arms

Prospective Registry

Treatment for diagnoses of long bone non-union involving the tibia or femur and other nonunion diagnosis (i.e. clavicle, humerus, and femur) with Vivigen Cellular Bone Matrix

Retrospective Data Collection

Treatment of diagnoses of long bone non-union involving the tibia or femur and other nonunion diagnosis (i.e. clavicle, humerus, and femur) with adjunct bone graft utilized in the acute, delayed, non-union and fusion settings.

Interventions

Vivigen Cellular Bone Matrix

Allograft bone matrix

Primary outcome measure

  • Reintervention Rate [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Barry Saxton, P.A.-C.

404 314 4903barry_saxton@lifenethealth.org

Alyce Jones, Ph.D.

alyce_jones@lifenethealth.org

Locations

OrlandoHealth

Recruiting

Orlando, Florida, United States, 32806

Contacts

David Krol

david.krol@orlandohealth.com

Principal Investigator:

M. Kareem Shaath, MD

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Carrigan Creech, BS

carrigan.creech@duke.edu

Principal Investigator:

Malcolm DeBaun, MD

Sentara Hospitals

Recruiting

Norfolk, Virginia, United States, 23507

Contacts

Susan Steele, RN, CCRC

757 803 3280srsteel1@Sentara.com

Principal Investigator:

Richard Myers, MD

More Information

Sponsor

LifeNet Health

Last update posted

Apr 2, 2025

Last verified

Mar, 2025

Keywords

  • fracture
  • nonunion
  • allograft

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by LifeNet Health on 2025-04-02.