NCT04299022 Safety, Efficacy, & Use of ViviGen Cellular Bone Matrix Allograft in Orthopaedic Fracture Care
| NCT ID | NCT04299022 |
| Status | Recruiting |
| Phase | — |
| Sponsor | LifeNet Health |
| Condition | Fractures, Bone |
| Study Type | OBSERVATIONAL |
| Enrollment | 250 participants |
| Start Date | 2021-06-01 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 250 participants in total. It began in 2021-06-01 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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: 1. Patients unable to understand either an English or Spanish consent will be excluded. 2. Patients unable to consent secondary to dementia and/or other mental/psychiatric diagnoses will be excluded.
Contact & Investigator
Alyce Jones, Ph.D
STUDY DIRECTOR
LifeNet Health
Frequently Asked Questions
Who can join the NCT04299022 clinical trial?
This trial is open to participants of all sexes, studying Fractures, Bone. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04299022 currently recruiting?
Yes, NCT04299022 is actively recruiting participants. Contact the research team at barry_saxton@lifenethealth.org for enrollment information.
Where is the NCT04299022 trial being conducted?
This trial is being conducted at Orlando, United States, Jersey City, United States, Durham, United States, Norfolk, United States.
Who is sponsoring the NCT04299022 clinical trial?
NCT04299022 is sponsored by LifeNet Health. The principal investigator is Alyce Jones, Ph.D at LifeNet Health. The trial plans to enroll 250 participants.