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Long-term Coated and Non-coated Tibia Nails

NCT04576052 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 397

Last updated 2026-05-15

No results posted yet for this study

Summary

For this retrospective cohort study, medical records of patients treated between 2005 to 2019 with the UTN PROtect and/or ETN PROtect for tibia fractures or tibia revision cases will be examined. In comparison to this cohort, patients who received an uncoated tibia nail are examined as well. Demographics, pre-surgical health status, details on fracture type or on revision, treatment decision and surgery details, postoperative reoperation and revision, surgical site infections, time to union, and adverse events will be registered. In a subgroup, additional information including clinical outcomes and patient satisfaction will be assessed by clinical exam. Patients who still carry a nail and feel discomfort at the surgical site or present with a medical condition which demands an imaging will receive an x-ray of the tibia. The xray is not part of the standard study protocol.

Conditions

  • Implant Infection

Sponsors & Collaborators

  • Synthes GmbH

    collaborator INDUSTRY

  • University Hospital Muenster

    lead OTHER

Principal Investigators

  • Michael J. Raschke, Prof. Dr. · University Hospital Muenster

  • Steffen Roßlenbroich, Dr. · University Hospital Muenster

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-18
Primary Completion
2025-06-30
Completion
2025-12-31

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 NCT04576052 on ClinicalTrials.gov