At a glance
ClinicalIndex Comparison RecordN/ACompleted· 100 enrolled
Drug / intervention
ETN PROtectdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
An observational study evaluating ETN PROtect for Tibia Fractures. Completed, enrolled 100 participants across 4 sites.
Detailed 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.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsTibia Fractures
CountriesGermany
Collaborators--
Timeline
N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 2011
Enrollment StartFeb 2011
Primary CompletionOct 2013
Study CompletionDec 2013
TodayJul 2026
First PostedJan 24, 2011
Enrollment StartFeb 1, 2011
Primary CompletionOct 1, 2013
Study CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 15.4 years ago
Interventions
ETN PROtectdevice
Expert Tibial Nail PROtect with Gentamicin coating