Clinical Trial

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

Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated April 2, 2025 (before its estimated July 31, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2020-03-04; most recent amendment 2025-03-28.
Status change: Not Yet Recruiting → Recruiting 2021-09-09
Trial Details
NCT Number NCT04299022
Lead Sponsor LifeNet Health
Conditions Fractures, Bone, Nonunion of Fracture, Fractures, Open, Fractures, Ununited, Fracture, Tibial, Fracture of Femur, Fracture Arm
Enrollment 250 participants
Start Date 2021-06-01
Primary Completion 2026-07-31 (estimated)
Study Completion 2026-07-31 (estimated)
Updated on ClinicalTrials.gov 2025-04-02