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.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Safety, Efficacy, & Use of ViviGen Cellular Bone Matrix Allograft in Orthopaedic Fracture Care
At a glance
Conditions
Where it's being run
4 sites across 4 statesStudy leadership
- Alyce Jones, Ph.D · STUDY_DIRECTOR · LifeNet Health
Who to contact
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Do you actually qualify for this trial?
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Inclusion
What this trial measures
- Reintervention Rate24 months
the proportion of patients requiring secondary intervention (return to the operating room) within twelve months after definitive wound closure