Safety, Efficacy, & Use of ViviGen Cellular Bone Matrix Allograft in Orthopaedic Fracture Care
Recruiting
Observational Study
Fractures, Bone
Nonunion of Fracture
Fractures, Open
Fractures, Ununited
Fracture, Tibial
Fracture of Femur
Fracture Arm
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Sex
- Any
- Study type
- Observational
- Participants needed
- 250 (estimated)
- Sponsor
- LifeNet Health · Industry
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About This Trial
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.
Trial Locations
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Eligibility 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 a…
Contacts