RecruitingNCT04299022

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

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

Sponsor

LifeNet Health

Enrollment

250 participants

Start Date

Jun 1, 2021

Study Type

OBSERVATIONAL

Conditions

Fractures, Bone Fractures, Open Nonunion of Fracture Fractures, Ununited Fracture, Tibial Fracture of Femur Fracture Arm

Summary

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.

Eligibility

Inclusion Criteria2

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.
\- 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.

Exclusion Criteria2

Patients unable to understand either an English or Spanish consent will be excluded.
Patients unable to consent secondary to dementia and/or other mental/psychiatric diagnoses will be excluded.

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