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Evaluation of Trinity Evolution in Patients Undergoing Foot and Ankle Fusion

NCT00988338 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 106

Last updated 2021-10-28

No results posted yet for this study

Summary

The purpose of this study is to utilize Trinity Evolution as a graft source in foot/ankle fusions and to follow the subjects to measure the clinical outcomes and fusion rate. The hypothesis of the study is that Trinity Evolution will result in fusion rates and clinical outcomes similar to those obtained from autograft and other routinely used allograft materials; these include: fusion, improvement in pain, improvement in function, and absence of adverse events related to the use of the graft source.

Conditions

  • Tibiotalar Arthrodesis
  • Subtalar Arthrodesis
  • Calcaneocuboid Arthrodesis
  • Talonavicular Arthrodesis
  • Double Arthrodesis (i.e. Calcaneocuboid and Talonavicular)
  • Triple Arthrodesis (i.e. Subtalar, Calcaneocuboid, and Talonavicular)

Interventions

BIOLOGICAL

Trinity Evolution

Novel Allogeneic, Cancellous, Bone Matrix Containing Viable Stem and Osteoprogenitor Cells

Sponsors & Collaborators

  • Orthofix Inc.

    lead INDUSTRY

Principal Investigators

  • Raymond J Linovitz, MD · Orthofix Inc.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00988338 on ClinicalTrials.gov