ClinicalTrials.Veeva

Menu

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

DePuy Synthes logo

DePuy Synthes

Status

Completed

Conditions

Tibia Fractures

Treatments

Device: ETN PROtect

Study type

Observational

Funder types

Industry

Identifiers

NCT01282294
STU-BIO-T-XX-190-02

Details and patient eligibility

About

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.

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Adult patients aged 18 years or more
  • Open or closed tibia fracture according to the surgical technique

Exclusion criteria

  • Women who are pregnant or breast-feeding or are planning to become pregnant during the study
  • Patients with consumptive/ malignant primary disease and a life expectancy of < 3 months
  • Patients with a known allergy to aminoglycosides
  • Physical or mental incapacity, which makes it impossible to obtain informed consent
  • History of drug and alcohol abuse
  • Patient unlikely to cooperate
  • Legal incompetence

Trial design

100 participants in 1 patient group

ETN PROtect
Description:
There is only 1 cohort in this case series
Treatment:
Device: ETN PROtect

Trial contacts and locations

4

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems