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Clinical trial Recruiting at 2 sites Observational

Using ViviGen Cellular Bone Matrix for treating fractures

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

Run by LifeNet Health · NCT04299022 · Data updated 2026-11-12

This study is testing if ViviGen Cellular Bone Matrix can help people with different types of fractures heal better and faster.

Quick facts

Study typeObservational
SexAll
Enrollment250 (estimated)
SponsorLifeNet Health
Industry-sponsored
Locations4 sites (Orlando, Florida and 3 other locations)
StatusRecruiting
StartedJune 1, 2021
Main results expectedJuly 31, 2028
Study endsJuly 31, 2028
Registry record updatedSeptember 15, 2026
Trial IDNCT04299022 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are skeletally mature patients undergoing treatment for acute fractures, delayed non-unions, or fusion procedures.

Probably not a fit

Patients who are unable to consent due to mental health issues or language barriers may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study assesses the safety and efficacy of ViviGen Cellular Bone Matrix in patients with various types of fractures, including acute, delayed, and non-union fractures. It involves both a prospective registry and retrospective data collection, evaluating patients at multiple time points post-treatment. The goal is to determine how well ViviGen aids in bone healing and recovery in orthopedic trauma cases.

Why it matters

Potential benefit: If successful, this could improve healing outcomes for patients with challenging fractures requiring bone grafting.

How similar studies have gone: Other studies have explored the use of cellular bone matrices, showing promising results, but this specific application of ViviGen is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • OrlandoHealth
    Orlando, Florida, United States     Recruiting
  • RWJBarnabas Health
    Jersey City, New Jersey, United States     Recruiting
  • Duke University Medical Center
    Durham, North Carolina, United States     Active not recruiting
  • Sentara Hospitals
    Norfolk, Virginia, United States     Completed

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov ↗ Find more trials like this →
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.