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

Part of paid clinical trials in Orlando, Florida.

Sponsor
LifeNet Health
Study ID
NCT04299022
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vivigen Cellular Bone Matrix — OTHER
    Allograft bone matrix

Study Details

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.

Key Dates

Start date
Jun 1, 2021
Status verified
Mar 2025
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
250 participants (estimated)

Arms

  • Arm: Prospective Registry
    Treatment for diagnoses of long bone non-union involving the tibia or femur and other nonunion diagnosis (i.e. clavicle, humerus, and femur) with Vivigen Cellular Bone Matrix
  • Arm: Retrospective Data Collection
    Treatment of diagnoses of long bone non-union involving the tibia or femur and other nonunion diagnosis (i.e. clavicle, humerus, and femur) with adjunct bone graft utilized in the acute, delayed, non-union and fusion settings.

Primary Outcome Measure

Reintervention Rate [ Time Frame: 24 months ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
OrlandoHealthOrlandoFlorida32806
M. Kareem Shaath, MD (PRINCIPAL_INVESTIGATOR)
RWJBarnabas HealthJersey CityNew Jersey07302
Ian Hong, MD candidate
[email protected]
914 671 7325
Richard Yoon, MD (PRINCIPAL_INVESTIGATOR)
Duke University Medical CenterDurhamNorth Carolina27710
Carrigan Creech, BS
[email protected]
Malcolm DeBaun, MD (PRINCIPAL_INVESTIGATOR)
Sentara HospitalsNorfolkVirginia23507
Susan Steele, RN, CCRC
[email protected]
757 803 3280
Richard Myers, MD (PRINCIPAL_INVESTIGATOR)

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