Outcome Following Semitubular Plate vs. Polyaxial Locking Plates

Study Overview
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Brief Summary
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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.

Official Title
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a Prospective Randomized Study on the Outcome Following Osteosynthesis of Distal Fibula Fracture Using Semitubular Plate in AO Technique vs. Polyaxial Locking Plates

Conditions
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Ankle Fractures

Intervention / Treatment
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* Procedure: ORIF non-locking
* Procedure: ORIF locking


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1/3 tubular plate<br>Standard care according to AO guidelines using the Implant 1/3 tubular plate | Procedure: ORIF non-locking<br>* Open reduction and internal fixation using 1/3 tubular plate<br>|
| Active Comparator: Active ankle plate<br>Actual care using the new implant using the Implant Active ankle plate | Procedure: ORIF locking<br>* Open reduction and internal fixation using active ankle polyaxial locking plate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ankle function | Clinical objective ankle function assessed by Olerud and Molander ankle score (OMAS) | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ankle function | Clinical objective ankle function assessed by Foot and Ankle outcome score (FAOS) | 12 month |