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

Sponsor

LifeNet Health (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04299022

Collaborator

(none)

250

Enrollment

Locations

Anticipated Duration (Months)

62.5

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fractures, Bone Nonunion of Fracture Fractures, Open Fractures, Ununited Fracture, Tibial Fracture of Femur Fracture Arm	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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

250 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Jun 1, 2021

Anticipated Primary Completion Date :

Jul 31, 2023

Anticipated Study Completion Date :

Jul 31, 2025

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Reintervention Rate [24 months]
the proportion of patients requiring secondary intervention (return to the operating room) within twelve months after definitive wound closure

Secondary Outcome Measures

Fusion Rate [24 months]
Acute fracture, delayed union or nonunion rate as assessed with radiographs at 6 weeks, 3 months, 6 months, 12 months and 24 months
Patient Reported Outcome Measurement Information System (PROMIS) Scores [24 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

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:

Patients unable to understand either an English or Spanish consent will be excluded.
Patients unable to consent secondary to dementia and/or other mental/psychiatric diagnoses will be excluded.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	OrlandoHealth	Orlando	Florida	United States	32806
2	RWJBarnabas Health	Jersey City	New Jersey	United States	07302
3	Duke University Medical Center	Durham	North Carolina	United States	27710
4	Sentara Hospitals	Norfolk	Virginia	United States	23507