RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2021-06-01
Study Completion:2026-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04299022

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Not specified
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  1. 1. Patients unable to understand either an English or Spanish consent will be excluded.
  2. 2. Patients unable to consent secondary to dementia and/or other mental/psychiatric diagnoses will be excluded.

Contacts and Locations

Study Contact

Barry Saxton, P.A.-C.
CONTACT
404 314 4903
barry_saxton@lifenethealth.org
Alyce Jones, Ph.D.
CONTACT
alyce_jones@lifenethealth.org

Principal Investigator

Alyce Jones, Ph.D
STUDY_DIRECTOR
LifeNet Health

Study Locations (Sites)

OrlandoHealth
Orlando, Florida, 32806
United States
RWJBarnabas Health
Jersey City, New Jersey, 07302
United States
Duke University Medical Center
Durham, North Carolina, 27710
United States
Sentara Hospitals
Norfolk, Virginia, 23507
United States

Collaborators and Investigators

Sponsor: LifeNet Health

  • Alyce Jones, Ph.D, STUDY_DIRECTOR, LifeNet Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-06-01
Study Completion Date2026-07-31

Study Record Updates

Study Start Date2021-06-01
Study Completion Date2026-07-31

Terms related to this study

Keywords Provided by Researchers

  • fracture
  • nonunion
  • allograft

Additional Relevant MeSH Terms

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