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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Fractures, Bone; Nonunion of Fracture; Fractures, Ununited; Fractures, Open; Fracture of Femur; Fracture, Tibial; Fracture Arm
• Intervention / Treatment: Other: Vivigen Cellular Bone Matrix

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.

• Study Type: Observational
• Enrollment (Anticipated): 250

Contacts and Locations

• Study Contact: Name: Barry Saxton, P.A.-C.; Phone Number: 404 314 4903; Email: barry_saxton@lifenethealth.org

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32806
      • Recruiting
      • OrlandoHealth
  • New Jersey
    • Jersey City, New Jersey, United States, 07302
      • Not yet recruiting
      • RWJBarnabas Health
      • Contact: Ian Hong, MD candidate; Phone Number: 914-671-7325; Email: ian.hong@rwjbh.org
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke University Medical Center
      • Principal Investigator: Malcolm DeBaun, MD
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Recruiting
      • Sentara Hospitals
      • Contact: Susan Steele, RN, CCRC; Phone Number: 757-803-3280; Email: srsteel1@Sentara.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Prospective Registry; Treatment for diagnoses of long bone non-union involving the tibia or femur and other nonunion diagnosis (i.e. clavicle, humerus, and femur) with Vivigen Cellular Bone Matrix	Other: Vivigen Cellular Bone Matrix; Allograft bone matrix
Retrospective Data Collection; Treatment of diagnoses of long bone non-union involving the tibia or femur and other nonunion diagnosis (i.e. clavicle, humerus, and femur) with adjunct bone graft utilized in the acute, delayed, non-union and fusion settings.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reintervention Rate	the proportion of patients requiring secondary intervention (return to the operating room) within twelve months after definitive wound closure	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: LifeNet Health
• Investigators: Study Director: Alyce Jones, Ph.D, LifeNet Health

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Anticipated): July 31, 2024
• Study Completion (Anticipated): July 31, 2026

Study Registration Dates

• First Submitted: March 4, 2020
• First Submitted That Met QC Criteria: March 4, 2020
• First Posted (Actual): March 6, 2020

Study Record Updates

• Last Update Posted (Estimate): March 3, 2023
• Last Update Submitted That Met QC Criteria: March 1, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: allograft; fracture; nonunion
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Fractures, Bone; Tibial Fractures; Fractures, Ununited; Fractures, Open
• Other Study ID Numbers: CR-20-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No