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BioFiber Scaffold Post-Market Observational Study

NCT01849458 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2017-06-22

Study results available
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Summary

The aim of this study is to collect and report data from a consecutive series of patients implanted with these products as part of a post-market surveillance plan for CE Mark approval in the European Union.

Conditions

  • Full Thickness Rotator Cuff Tear

Interventions

DEVICE

BioFiber

Subjects implanted with BioFiber or BioFiber-CM Scaffold

Sponsors & Collaborators

  • Stryker Trauma and Extremities

    lead INDUSTRY

Principal Investigators

  • Stephen Brockmeier, MD · University of Virginia

  • Timothy Reish, MD · Insall Scott Kelly Institute

  • Philippe Collin, MD · St. Gregoire, France

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • United States
  • France

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 NCT01849458 on ClinicalTrials.gov