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Clinical Follow-up to Evaluate the Clinical Usefulness of Gentamicin-coated Titanium Nails in Tibia Fractures

NCT01282294 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2015-03-17

Study results available
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Summary

This post market clinical follow-up is to confirm the clinical usefulness of the Expert Tibial Nail (ETN) PROtect device for operative stabilization in patients with a tibia fracture as measured by the quality of life (EQ5D, SF-12) instruments, disease-specific questionnaires (Iowa Ankle Score, WOMAC) and assessment of (Non-)Device Related Adverse Events or complications.

Conditions

  • Tibia Fractures

Interventions

DEVICE

ETN PROtect

Expert Tibial Nail PROtect with Gentamicin coating

Sponsors & Collaborators

  • Synthes GmbH

    lead INDUSTRY

Principal Investigators

  • Michael J. Raschke, MD · University Hospital of Münster, Germany

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2013-10-31
Completion
2013-12-31

Countries

  • Germany

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 NCT01282294 on ClinicalTrials.gov