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

Recruiting

• Conditions: Fracture of Femur; Fractures, Ununited; Nonunion of Fracture; Fractures, Open; Fracture Arm; Fractures, Bone; Fracture, Tibial
• Interventions: Other: Vivigen Cellular Bone Matrix

• Registration Number: NCT04299022
• Lead Sponsor: LifeNet Health

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-03-04
• Study First Submitted QC: 2020-03-04
• Study First Posted: 2020-03-06
• Study Start: 2021-06-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-04-02
• Primary Completion: 2026-07-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prospective Registry	Vivigen Cellular Bone Matrix	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

Primary Outcome Measures

Name	Time	Method
Reintervention Rate	24 months	the proportion of patients requiring secondary intervention (return to the operating room) within twelve months after definitive wound closure

Secondary Outcome Measures

Name	Time	Method
Patient Reported Outcome Measurement Information System (PROMIS) Scores	24 months	Patient reported outcome measures will be measured via PROMIS scoring tool (mental and physical). The PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. For PROMIS measures, higher scores equals more of the concept being measured (e.g., more Fatigue, more Physical Function). Thus a score of 60 is one standard deviation above the average referenced population.
Fusion Rate	24 months	Acute fracture, delayed union or nonunion rate as assessed with radiographs at 6 weeks, 3 months, 6 months, 12 months and 24 months

Trial Locations

Locations (4)

RWJBarnabas Health; 🇺🇸 Jersey City, New Jersey, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Sentara Hospitals; 🇺🇸 Norfolk, Virginia, United States

OrlandoHealth; 🇺🇸 Orlando, Florida, United States