Clinical and radiological outcome after treatment of a foot complex trauma by means of external fixator
- Conditions
- Complex foot trauma describes high-energy injuries to the foot that include various fractures from the ankle to the forefoot. In most cases, these fractures are associated with severe soft tissue damage up to open fractures due to the high energy of the trauma. Correspondingly, there is often costly treatment and sometimes considerable complications resulting in the need for flap plastic surgery or even amputation.
- Registration Number
- DRKS00031848
- Lead Sponsor
- BGKlinik für Unfall- und Wiederherstellungschirurgie der Eberhard-Karls-Universität Tübingen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 150
Patients who have been surgically treated by an external fixator since 2015 following complex trauma to the foot after receiving a positive vote from the ethics committee at BG Unfallklinik Tübingen and who consent to study participation and the associated data collection.
-Patient or legal guardian refuses study participation
-Patients with advanced dementia
-Patients with systemic or tumor diseases that could affect bone remodeling
-Positive history of past abuse of alcohol and/or drugs
-Existing pregnancy or planned pregnancy during the study period
-Incarcerated individuals
-Participation in another medical study that could affect the results of the present study
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Quality of Life after Complex Foot Trauma measured by PROMIS 29 Score
- Secondary Outcome Measures
Name Time Method -registration of the clinical and radiological outcome after treatment with foot fixators <br>-registration of the return to working life after therapy with fixator systems<br>-registration of complication rates and quality of life<br>-registration of the gait pattern of the foot after a complex trauma and surgical treatment with an external fixator in comparison with the undamaged foot and in comparison with the normal collective