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

  • STATUS
    Recruiting
  • End date
    Jul 31, 2025
  • participants needed
    250
  • sponsor
    LifeNet Health
Updated on 23 September 2021
fracture care

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.

Description

The prospective registry study and retrospective data collection study is planned 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.

Patients will be assessed at hospital discharge, 6 weeks, 3 months, 6 months, 12 months and 24 months after treatment of a traumatic fracture with a bone graft.

Details
Condition Fracture, femoral fractures, Fractures of the Upper Limb, Bone Fractures, Open Fracture, fracture nonunion, Fracture of femur, femur fracture, Nonunion of fracture, Fracture of tibia
Treatment ViviGen Cellular Bone Matrix
Clinical Study IdentifierNCT04299022
SponsorLifeNet Health
Last Modified on23 September 2021

Eligibility

Yes No Not Sure

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

Exclusion Criteria

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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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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