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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 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04299022
Study type Observational [Patient Registry]
Source LifeNet Health
Contact Barry Saxton, P.A.-C.
Phone 404 314 4903
Email barry_saxton@lifenethealth.org
Status Recruiting
Phase
Start date June 1, 2021
Completion date July 31, 2026
View Details
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