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

Safety, Efficacy, & Use of ViviGen Cellular Bone Matrix Allograft in Orthopaedic Fracture Care: A Multi-Center Prospective Registry and Retrospective Data Collection Study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04299022

Enrollment

250

Registered

2020-03-06

Start date

2021-06-01

Completion date

2028-07-31

Last updated

2026-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fracture Arm, Fracture of Femur, Fractures, Bone, Fractures, Open, Fractures, Ununited, Fracture, Tibial, Nonunion of Fracture

Keywords

fracture, nonunion, allograft

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.

Interventions

OTHERVivigen Cellular Bone Matrix

Allograft bone matrix

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Inclusion criteria

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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
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.

Countries

United States

Contacts

CONTACTMonique Alston-Epps

monique_alstonepps@lifenethealth.org757-609-4378

CONTACTKimberly Dorsch

kimberly_dorsch@lifenethealth.org757-609-4378

STUDY_DIRECTORKimberly Dorsch

LifeNet Health

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 16, 2026