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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-02-28

Study Completion Date

2013-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Tibia Fractures

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ETN PROtect

There is only 1 cohort in this case series

ETN PROtect

Intervention Type DEVICE

Expert Tibial Nail PROtect with Gentamicin coating

Interventions

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ETN PROtect

Expert Tibial Nail PROtect with Gentamicin coating

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No