a Prospective Randomized Study on the Outcome Following Osteosynthesis of Distal Fibula Fracture Using Semitubular Plate in AO Technique vs. Polyaxial Locking Plates
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ankle Fractures
- Sponsor
- Technical University of Munich
- Enrollment
- 45
- Primary Endpoint
- Ankle function
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Investigators
Dr. Chlodwig Kirchhoff
Clinical Professor
Technical University of Munich
Eligibility Criteria
Inclusion Criteria
- •age between 18 and 65 years
- •Fracture of the distal fibula (AO 44 B1.1, B1.2, B1.3)
- •Written informed consent
Exclusion Criteria
- •Pregnancy
- •mental disorders
- •comprehensive legal support.
- •pathological and/or osteoporotic fracture
- •open fracture
Outcomes
Primary Outcomes
Ankle function
Time Frame: 12 month
Clinical objective ankle function assessed by Olerud and Molander ankle score (OMAS)
Secondary Outcomes
- Ankle function(12 month)