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Clinical Trials/NCT04370561
NCT04370561
Completed
Not Applicable

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

Technical University of Munich0 sites45 target enrollmentJanuary 1, 2016
ConditionsAnkle Fractures

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2016
End Date
January 1, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Technical University of Munich
Responsible Party
Principal Investigator
Principal Investigator

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)

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