Using ViviGen Cellular Bone Matrix for treating fractures
Safety, Efficacy, & Use of ViviGen Cellular Bone Matrix Allograft in Orthopaedic Fracture Care: A Multi-Center Prospective Registry and Retrospective Data Collection Study
This study is testing if ViviGen Cellular Bone Matrix can help people with different types of fractures heal better and faster.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Sex | All |
| Sponsor | LifeNet Health Industry-sponsored |
| Locations | 4 sites (Orlando, Florida and 3 other locations) |
| Trial ID | NCT04299022 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are skeletally mature patients undergoing treatment for acute fractures, delayed non-unions, or fusion procedures.
Not a fit: Patients who are unable to consent due to mental health issues or language barriers may not benefit from this study.
Why it matters
Potential benefit: If successful, this could improve healing outcomes for patients with challenging fractures requiring bone grafting.
How similar studies have performed: Other studies have explored the use of cellular bone matrices, showing promising results, but this specific application of ViviGen is relatively novel.
Eligibility criteria
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 this trial is running
Orlando, Florida and 3 other locations
- OrlandoHealth — Orlando, Florida, United States (Recruiting)
- RWJBarnabas Health — Jersey City, New Jersey, United States (Not_yet_recruiting)
- Duke University Medical Center — Durham, North Carolina, United States (Recruiting)
- Sentara Hospitals — Norfolk, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Barry Saxton, P.A.-C.
- Email: barry_saxton@lifenethealth.org
- Phone: 404 314 4903
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.