Clinical trial NCT04299022: Safety, Efficacy, & Use of ViviGen Cellular Bone Matrix Allograft in Orthopaedic Fracture Care
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Fractures, Bone
Nonunion of Fracture
Fractures, Open
Fractures, Ununited
Fracture, Tibial
Fracture of Femur
Fracture Arm
Keywords: fracture
nonunion
allograft
Lead sponsor: LifeNet Health
Sponsor class: INDUSTRY
First posted: 2020-03-06
Enrollment: 250
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prospective data will be collected for up to 250 subjects across up to 7 academic medical centers that will receive Vivigen Cellular Bone Matrix for treatment of a fracture. Retrospective data will be collected for up to an additional 250 subjects that received a bone graft adjunct for treatment of a fracture.

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.

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.

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.

Primary outcomes:
measure: Reintervention Rate
timeFrame: 24 months
Secondary outcomes:
measure: Fusion Rate
timeFrame: 24 months
measure: Patient Reported Outcome Measurement Information System (PROMIS) Scores
timeFrame: 24 months
Other outcomes:
Locations:
city: Orlando
country: United States
facility: OrlandoHealth
state: Florida
city: Jersey City
country: United States
facility: RWJBarnabas Health
state: New Jersey
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Norfolk
country: United States
facility: Sentara Hospitals
state: Virginia
Study officials:
affiliation: LifeNet Health
name: Alyce Jones, Ph.D
role: STUDY_DIRECTOR
References: