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

Information source: Synthes GmbH
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Tibia Fractures

Intervention: ETN PROtect (Device)

Phase: N/A

Status: Completed

Sponsored by: Synthes GmbH

Official(s) and/or principal investigator(s):
Michael J. Raschke, MD, Principal Investigator, Affiliation: University Hospital of Münster, Germany

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.

Clinical Details

Official title: Prospective Open Label Post Market Clinical Follow-up to Evaluate the Clinical Usefulness of the Operative Stabilization of Closed and Open Fractures of the Tibia Using Gentamicin - Coated Titanium Nails

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome:

Quality of Life: SF-12 Physical Component Summary (PCS)

Quality of Life: SF-12 Mental Component Summary (MCS)

Quality of Life: EQ-5D

Functional Outcome: IOWA Ankle Score

Functional Outcome: WOMAC

Infection Adverse Events

Secondary outcome:

Evidence of Anatomic Bone Union According to Johnson Classification

Evidence of Economic Bone Union According to Johnson Classification

Evidence of Functional Bone Union According to Johnson Classification

Surgeon's Perceived Satisfaction

Likelihood to Develop Wound Infection Assessed by Surgeon

Likelihood to Develop a Non-union Assessed by Surgeon

Pain by Visual Analog Scale (VAS)

Patient's Perceived Satisfaction

Time to Full Weight Bearing

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Charité - Universitätsmedizin Berlin, Berlin 10117, Germany

Universitätsklinikum Freiburg, Freiburg 79106, Germany

Universitätsklinikum Heidelberg, Heidelberg 69120, Germany

University Hospital of Münster, Münster 48149, Germany

Additional Information

Starting date: February 2011
Last updated: February 25, 2015

Page last updated: August 23, 2015

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