Menu
Recruiting NCT04299022

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

— Observational Fractures, Bone Nonunion of Fracture Fractures, Open Fractures, Ununited

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Vivigen Cellular Bone Matrix.
Who it may be relevant to
Registry conditions: Fractures, Bone, Nonunion of Fracture, Fractures, Open, Fractures, Ununited. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed 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.

Interventions

  • Other Vivigen Cellular Bone Matrix
    Allograft bone matrix

Primary outcome measures

  • Reintervention Rate [Time frame: 24 months]
Secondary outcome measures (2)
  • Fusion Rate [Time frame: 24 months]
  • Patient Reported Outcome Measurement Information System (PROMIS) Scores [Time frame: 24 months]

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 adjunct bone graft in the setting of an acute fracture, delayed, non-union or fusion setting will eligible for inclusion.

Prospective Cohort 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 4 centers
  • OrlandoHealth — Orlando
  • RWJBarnabas Health — Jersey City
  • Duke University Medical Center — Durham
  • Sentara Hospitals — Norfolk

Identifiers

NCT: NCT04299022 · CR-20-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗