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Outcome Following Semitubular Plate vs. Polyaxial Locking Plates

NCT04370561 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2020-05-05

No results posted yet for this study

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.

Conditions

  • Ankle Fractures

Interventions

PROCEDURE

ORIF non-locking

Open reduction and internal fixation using 1/3 tubular plate

PROCEDURE

ORIF locking

Open reduction and internal fixation using active ankle polyaxial locking plate

Sponsors & Collaborators

  • Technical University of Munich

    lead OTHER

Principal Investigators

  • Chlodwig Kirchhoff, MD · Klinik für Unfallchirurgie, Klinikum rechts der Isar, TU München

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-01
Primary Completion
2018-01-01
Completion
2019-01-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04370561 on ClinicalTrials.gov