Functional outcome of distal fibula fractures comparing conventional AO-semitubular plating to minimally invasive intramedullary Photodynamic Bone Stabilization.
- Conditions
- S82.6Fracture of lateral malleolus
- Registration Number
- DRKS00025496
- Lead Sponsor
- TUM, Klinikum rechts der Isar, Klinik und Poliklinik für Unfallchirurgie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 45
Presence of a distal fibula fracture (according to AO 44 B1.1, B1.2, B1.3).
- Fulfilment of the criteria for surgical treatment:
- Corticalis disruption
- Shaft displacement >5mm
- Grade 0: No or insignificant soft tissue injury, indirect force, simple fracture form
- Grade I: Superficial skin abrasion or contusion due to fragment pressure from inside, simple to moderate fracture form
- Age: > 65 years
- Charlson score = 1
- Open fractures
- Lesions of the vessels or nerves
- Presence of a pathological fracture
- Polytrauma patients
- Prisoners, pregnant women and patients with known care needs
- Inflammatory underlying disease such as: sepsis, meningitis, HIV, hepatitis, etc.
- Neurological-psychiatric underlying disease
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary target parameters:<br>Radiological-morphological:<br>Position of the fracture fragments<br><br>Clinical-functional:<br>Weight-bearing and range of motion according to the neutral zero method<br>Consolidation of the tissue<br>
- Secondary Outcome Measures
Name Time Method Secondary target parameters:<br>Radiological-morphological: <br>Development of the fracture<br>Axial position (in the upper ankle joint)<br><br>Clinical data: <br>Medical history (risk factors, secondary diagnoses, family history).<br>Patient satisfaction (SF-36 II)<br>Complications<br>Pain (analgesic requirement)<br>Range of motion (n. neutral zero)