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Clinical Trial Details — Status: Recruiting

Administrative data

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

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
Health authority
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
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.

Study Design


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
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