Observational Study of ViviGen Cellular Bone Matrix for Fractures

This study is looking at how well ViviGen Cellular Bone Matrix, a type of bone graft (material used to help bones heal), works and if it's safe for people with fractures (broken bones). This includes acute fractures (recent breaks), delayed or ununited fractures (breaks that aren't healing well), and when used in fusion procedures (joining bones together). The study will follow patients who receive ViviGen to see if they need further surgery or treatment related to their fracture over 24 months. Anyone who is skeletally mature (done growing) and receives ViviGen for a fracture or fusion can be included in this study. The current recruitment status is unclear.

Study design
This is an observational study, meaning researchers will collect information from patients who are already receiving ViviGen. It aims to include 250 participants.
What's involved
You would be assessed at hospital discharge, then at 6 weeks, 3 months, 6 months, 12 months, and 24 months after your fracture treatment with a bone graft.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 24 months after their treatment to see if they need further surgery.

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NCT04299022

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

Recruiting
Not specifiedAll AgesObservational
LifeNet Health
~250 participants
Updated 2025-04-02 on ClinicalTrials.gov
What's tested:Vivigen Cellular Bone Matrix

At a glance

Recruiting sites
3 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Reintervention Rate
Measured over 24 months
Fractures, Bone
Nonunion of Fracture
Fractures, Open
Fractures, Ununited
Fracture, Tibial
Fracture of Femur
Fracture Arm
4 sites across 4 states
Florida1
New Jersey1
North Carolina1
Virginia1
  • Alyce Jones, Ph.D · STUDY_DIRECTOR · LifeNet Health

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Eligibility criteria

Inclusion

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.
  • Reintervention Rate24 months

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