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

Last updated: March 28, 2025
Sponsor: LifeNet Health
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Vivigen Cellular Bone Matrix

Clinical Study ID

NCT04299022
CR-20-002
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Prospective Cohort Inclusion Criteria:

  • Any skeletally mature patient treated with Vivigen bone graft in the setting of anacute 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 anacute fracture, delayed, non-union or fusion setting will eligible for inclusion.

Exclusion

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/psychiatricdiagnoses will be excluded.

Study Design

Total Participants: 250
Treatment Group(s): 1
Primary Treatment: Vivigen Cellular Bone Matrix
Phase:
Study Start date:
June 01, 2021
Estimated Completion Date:
July 31, 2026

Study Description

The prospective registry study and retrospective data collection study is planned 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.

Patients will be assessed at hospital discharge, 6 weeks, 3 months, 6 months, 12 months and 24 months after treatment of a traumatic fracture with a bone graft.

Connect with a study center

  • OrlandoHealth

    Orlando, Florida 32806
    United States

    Active - Recruiting

  • RWJBarnabas Health

    Jersey City, New Jersey 07302
    United States

    Site Not Available

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Active - Recruiting

  • Sentara Hospitals

    Norfolk, Virginia 23507
    United States

    Active - Recruiting

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