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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04299022
• Other study ID #: CR-20-002
• Status: Recruiting
• Start date: June 1, 2021
• Est. completion date: July 31, 2026

Study information

• Verified date: March 2023
• Source: LifeNet Health
• Contact: Barry Saxton, P.A.-C.
• Phone: 404 314 4903
• Email: barry_saxton[@]lifenethealth.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: July 31, 2026
• Est. primary completion date: July 31, 2024
• 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.

Related Conditions & MeSH terms

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

Intervention

Other:
• Vivigen Cellular Bone Matrix
Allograft bone matrix

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
LifeNet Health

Country where clinical trial is conducted

United States, 

Outcome

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