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OpenTrials
Completed

NCT Number: NCT04370561

Outcome Following Semitubular Plate vs. Polyaxial Locking Plates

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ORIF non-locking

Procedure

Open reduction and internal fixation using 1/3 tubular plate

ORIF locking

Procedure

Open reduction and internal fixation using active ankle polyaxial locking plate

Primary outcomes

  1. Ankle function

    Time frame: 12 month

    Clinical objective ankle function assessed by Olerud and Molander ankle score (OMAS)

Secondary outcomes

  1. Ankle function

    Time frame: 12 month

    Clinical objective ankle function assessed by Foot and Ankle outcome score (FAOS)

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
May 1, 2020
Registry last updated
May 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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