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Unimalleolar Versus Bimalleolar Fixation in Bi- or Trimalleolar Ankle Fracture

NCT01757951 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2022-11-02

No results posted yet for this study

Summary

A one third of all ankle fractures are bi- or trimalleolar. Traditionally these fractures are treated by both medial and lateral osteosynthesis, sometimes accompanied by osteosynthesis of the posterior malleolus. There is significant evidence that fractures of the lateral malleolus can be treated conservatively if the medial side is stable. However, there isn't a single study comparing standard bi- or trimalleolar fixation with only medial side osteosynthesis and postoperative immobilization with a cast.

Conditions

Interventions

PROCEDURE

Unimalleolar fixation

Medial malleolus is fixed first and after that ankle mortise stability is assessed using external-rotation stress test. If talocrural joint is stable after fixation of medial malleolus, the patient is randomized to unimalleolar fixation group and no fixation of the lateral side is performed.

PROCEDURE

Bimalleolar fixation

Medial malleolus is fixed first and after that ankle mortise stability is assessed using external-rotation stress test. If talocrural joint is stable after fixation of medial malleolus, the patient is randomized to bimalleolar fixation group i.e. additional fixation of the lateral malleolus fracture is performed.

Sponsors & Collaborators

  • University of Oulu

    lead OTHER

Principal Investigators

  • Harri J Pakarinen, MD, PhD, AP · Pohjois-Pohjanmaan sairaanhoitopiiri

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2024-12-31
Completion
2026-12-31

Countries

  • Finland

Study Locations

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Entities

Diseases

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 NCT01757951 on ClinicalTrials.gov