DRKS00025496CompletedPhase 4
Functional outcome of distal fibula fractures comparing conventional AO-semitubular plating to minimally invasive intramedullary Photodynamic Bone Stabilization.
TUM, Klinikum rechts der Isar, Klinik und Poliklinik für Unfallchirurgie0 sites45 target enrollmentStarted: July 5, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 45
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized controlled study
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- 65 Years to 100 Years (—)
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •- 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
Investigators
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