Fractures, Bone Clinical Trial
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
NCT number | NCT04299022 |
Other study ID # | CR-20-002 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 1, 2021 |
Est. completion date | July 31, 2026 |
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.
Status | Recruiting |
Enrollment | 250 |
Est. completion date | July 31, 2026 |
Est. primary completion date | July 31, 2024 |
Accepts healthy volunteers | |
Gender | All |
Age group | N/A and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Duke University Medical Center | Durham | North Carolina |
United States | RWJBarnabas Health | Jersey City | New Jersey |
United States | Sentara Hospitals | Norfolk | Virginia |
United States | OrlandoHealth | Orlando | Florida |
Lead Sponsor | Collaborator |
---|---|
LifeNet Health |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reintervention Rate | the proportion of patients requiring secondary intervention (return to the operating room) within twelve months after definitive wound closure | 24 months | |
Secondary | Fusion Rate | Acute fracture, delayed union or nonunion rate as assessed with radiographs at 6 weeks, 3 months, 6 months, 12 months and 24 months | 24 months | |
Secondary | Patient Reported Outcome Measurement Information System (PROMIS) Scores | Patient reported outcome measures will be measured via PROMIS scoring tool (mental and physical). The PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. For PROMIS measures, higher scores equals more of the concept being measured (e.g., more Fatigue, more Physical Function). Thus a score of 60 is one standard deviation above the average referenced population. | 24 months |
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