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

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