Trials / Completed
CompletedNCT01282294
Clinical Follow-up to Evaluate the Clinical Usefulness of Gentamicin-coated Titanium Nails in Tibia Fractures
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
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 100 (actual)
- Sponsor
- Synthes GmbH · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ETN PROtect | Expert Tibial Nail PROtect with Gentamicin coating |
Timeline
- Start date
- 2011-02-01
- Primary completion
- 2013-10-01
- Completion
- 2013-12-01
- First posted
- 2011-01-24
- Last updated
- 2015-03-17
- Results posted
- 2015-02-11
Locations
4 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT01282294. Inclusion in this directory is not an endorsement.