Status:
UNKNOWN
Full-Weightbearing Following Ankle Fractures Surgically Treated - The FAST-Mobility Trial
Lead Sponsor:
Ludwig-Maximilians - University of Munich
Collaborating Sponsors:
Universitätsklinikum Hamburg-Eppendorf
University Medical Center Rostock
Conditions:
Rehabilitation of Surgically Treated Ankle Fractures
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
The aim of this study is to investigate complication rates and clinical outcome following mobilization and pain-dependent full weight-bearing in a large cohort of patients with surgically treated ankl...
Detailed Description
Background Ankle fractures are among the most common fractures in adulthood. Various novel surgical treatment strategies have been developed but nothing has changed regarding the postoperative treatme...
Eligibility Criteria
Inclusion
- Patients aged above 18 years Independently living and mobile
- Preoperative imaging:
- Unimalleolar fracture: Radiographs in two planes or unilateral CT
- Bi-/Trimalleolar fracture: Unilateral CT Isolated ankle fracture (uni-/ bi-/ trimalleolar fracture)
- Surgical treatment:
- Posterior malleolus: Undisplaced fracture: Treatment according to the surgeon's preference; Displaced (≥2mm) fragment of sufficient size (approximately ≥10% of the lateral distal tibia): Open reduction and internal fixation using screw(s) and / or plate(s); Displaced (≥2mm), small fragment (approximately \<10% of the lateral distal tibia): Treatment according to the surgeon's preference.
- Lateral malleolus: Open reduction and internal fixation by plate ± compression screw(s).
- Medial malleolus: Closed or open reduction and internal fixation by screw(s) and / or plate(s) osteosynthesis.
- Bony avulsions of the AiTFL (Wagstaffe-Fragment / Tubercule des Chaput): Treatment according to the surgeon's preference.
- Lesions to the Deltoid ligament: Treatment according to the surgeon's preference.
- Arthroscopic assisted fracture treatment: Decision up to the individual surgeon
- Postoperative imaging:
- Unimalleolar fracture: Radiographs in two planes or unilateral CT
- Bi-/Trimalleolar fracture: Uni- or bilateral CT Capable of reading and completing the study consent
Exclusion
- Age under 18 Surgical stabilization of the distal tibio-fibular joint by syndesmotic screw or dynamic stabilization Concomitant injuries, Charcot neuroarthropathy, pre-existing arthritis, deformity
- Tibial pilon fractures, Non-operative treatment
- Inability to provide consent, or declining participation
Key Trial Info
Start Date :
May 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2024
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT05419154
Start Date
May 30 2022
End Date
May 1 2024
Last Update
July 6 2022
Active Locations (1)
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1
Department of Trauma Surgery, Medical University of Munich
Munich, Germany, 80336