Outcome Following Semitubular Plate vs. Polyaxial Locking Plates

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Ankle Fractures

Clinical Trial Details

NCT number	NCT04370561
Study type	Interventional
Source	Technische Universität München
Contact
Status	Completed
Phase	N/A
Start date	January 1, 2016
Completion date	January 1, 2019

View Details

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