Clinical trial NCT01282294: Clinical Follow-up to Evaluate the Clinical Usefulness of Gentamicin-coated Titanium Nails in Tibia Fractures
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tibia Fractures
Lead sponsor: Synthes GmbH
Sponsor class: INDUSTRY
First posted: 2011-01-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting to the ER with a tibia fracture

Brief 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.


Eligibility 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

Primary outcomes:
measure: Quality of Life: SF-12 Physical Component Summary (PCS)
timeFrame: 3, 6, 12 and 18 months post-operatively
measure: Quality of Life: SF-12 Mental Component Summary (MCS)
timeFrame: 3, 6, 12 and 18 months post-operatively
measure: Quality of Life: EQ-5D
timeFrame: 3, 6, 12 and 18 months post-operatively
measure: Functional Outcome: IOWA Ankle Score
timeFrame: Baseline, 3, 6, 12 and 18 months post-operatively
measure: Functional Outcome: WOMAC
timeFrame: 3, 6, 12 and 18 months post-operatively
measure: Infection Adverse Events
timeFrame: 0 - 18 months
Secondary outcomes:
measure: Evidence of Anatomic Bone Union According to Johnson Classification
timeFrame: 12 months
measure: Evidence of Economic Bone Union According to Johnson Classification
timeFrame: 12 months
measure: Evidence of Functional Bone Union According to Johnson Classification
timeFrame: 12 months
measure: Surgeon's Perceived Satisfaction
timeFrame: 6 weeks, 3 and 6 months post-operatively
measure: Likelihood to Develop Wound Infection Assessed by Surgeon
timeFrame: 6 weeks, 3 and 6 months post-operatively
measure: Likelihood to Develop a Non-union Assessed by Surgeon
timeFrame: 6 weeks, 3 and 6 months post-operatively
measure: Pain by Visual Analog Scale (VAS)
timeFrame: 6 weeks, 3, 6, 12 and 18 months post-operatively
measure: Patient's Perceived Satisfaction
timeFrame: 6 months
measure: Time to Full Weight Bearing
timeFrame: 0 - 18 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Münster
country: Germany
facility: University Hospital of Münster
Study officials:
affiliation: University Hospital of Münster, Germany
name: Michael J. Raschke, MD
role: PRINCIPAL_INVESTIGATOR
References: