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

NCT04299022 | Recruiting DMC

• 1 other identifier: CR-20-002
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 4

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; Fracture of Femur; Fracture Arm

Keywords

fracture; nonunion; allograft

Outcome Measures

Primary Outcomes (1)

• Reintervention Rate

  the proportion of patients requiring secondary intervention (return to the operating room) within twelve months after definitive wound closure

  24 months

Secondary Outcomes (2)

• Fusion Rate

  24 months

• Patient Reported Outcome Measurement Information System (PROMIS) Scores

  24 months

Study Arms (2)

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

Other: 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 OTHER

Allograft bone matrix

Prospective Registry

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Prospective data will be collected for up to 250 subjects across up to 7 academic medical centers that will receive Vivigen Cellular Bone Matrix for treatment of a fracture. Retrospective data will be collected for up to an additional 250 subjects that received a bone graft adjunct for treatment of a fracture.

You may not qualify if:

• 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.

Sponsors & Collaborators

• LifeNet Health: lead

Study Sites (4)

OrlandoHealth

Orlando, Florida, 32806, United States

RECRUITING

RWJBarnabas Health

Jersey City, New Jersey, 07302, United States

NOT YET RECRUITING

Duke University Medical Center

Durham, North Carolina, 27710, United States

RECRUITING

Sentara Hospitals

Norfolk, Virginia, 23507, United States

RECRUITING

MeSH Terms

Conditions

Fractures, Bone; Fractures, Ununited; Fractures, Open; Tibial Fractures; Femoral Fractures

Condition Hierarchy (Ancestors)

Wounds and Injuries; Leg Injuries

Study Officials

• Alyce Jones, Ph.D

  LifeNet Health

  STUDY DIRECTOR

Central Study Contacts

Barry Saxton, P.A.-C.

CONTACT

404 314 4903; barry_saxton@lifenethealth.org

Alyce Jones, Ph.D.

CONTACT

alyce_jones@lifenethealth.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2020
• First Posted: March 6, 2020
• Study Start: June 1, 2021
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)