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NCT Number: NCT04299022

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

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.

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Key information

Conditions

Fractures, Bone Femoral Fractures Fracture Arm Fracture of Femur Fracture, Tibial Fractures, Open Fractures, Ununited Leg Injuries Nonunion of Fracture Tibial Fractures Wounds and Injuries

Sex eligibility

All sexes

Study type

Observational

Primary location

OrlandoHealth, Orlando, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vivigen Cellular Bone Matrix

Other

Allograft bone matrix

Primary outcomes

  1. Reintervention Rate

    Time frame: 24 months

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

Secondary outcomes

  1. Fusion Rate

    Time frame: 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

  2. Patient Reported Outcome Measurement Information System (PROMIS) Scores

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alyce Jones, Ph.D.

CONTACT

[email protected]

Barry Saxton, P.A.-C.

CONTACT

[email protected]

404 314 4903

Sponsors and collaborators

Lead sponsor

LifeNet Health

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Mar 6, 2020
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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