In this prospective study, all patients with distal fibula fractures (AO 44 B1.1, B1.2, B1.3), with indication for surgery were included. Patients were randomized to either the DePuy Synthes® one-third semitubular plate (Group I) or NEWCLIP TECHNICS, Active Ankle® polyaxial locking plate (Group II). In Group II early weight bearing was allowed after two weeks postoperatively. Primary outcome parameter was function of the ankle joint, assessed by the Olerud and Molander ankle score (OMAS), Foot and Ankle outcome score (FAOS) and Karlsson and Peterson Scoring System for Ankle function (KPSS). Secondary outcome parameter were postoperative complications. Superficial wound infection, delayed wound healing, mechanically prominent implant, skin irritations were considered as minor and deep wound infection, material loosening, loss of reduction were regarded as major complications requiring revision surgery. Clinical and radiological follow-up were performed 6 and 12 weeks, 6 months and 1 year postoperatively.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Open reduction and internal fixation using 1/3 tubular plate
Open reduction and internal fixation using active ankle polyaxial locking plate
Ankle function
Clinical objective ankle function assessed by Olerud and Molander ankle score (OMAS)
Time frame: 12 month
Ankle function
Clinical objective ankle function assessed by Foot and Ankle outcome score (FAOS)
Time frame: 12 month
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