Non--operative Treatment of the Medial Malleolus in bi- and Trimalleolar Ankle Fractures

September 27, 2011 updated by: Oslo University Hospital

Non--operative Treatment of the Medial Malleolus in bi- and Trimalleolar Ankle Fractures. A Randomized Controlled Trial

The purpose of this study was to determine if internal fixation of the medial malleolus is necessary following open reduction and internal fixation of the lateral and, if required, the posterior malleolus treating displaced bi-or trimalleolar ankle fractures.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0424
        • Oslo University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with Orthopaedic Trauma Association (OTA) type 44 fractures (B2-3 and C2-3).

Exclusion Criteria:

  • Patients with OTA type 43 distal tibia fractures.
  • Patients with soft tissue injuries involving the medial malleolus.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Surgery
Procedure: Internal fixation
Internal fixation of the medial malleolus following open reduction and internal fixation of the lateral and, if required, posterior malleolus.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
American Orthopaedic Foot and Ankle Society ankle hind foot score (AOFAS)
Time Frame: Average of 42 months
Average of 42 months
The Olerud Molander Ankle score (OMAS)
Time Frame: Average of 42 months
Average of 42 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Posttraumatic osteoarthritis (OA) according to the criteria of Magnusson (stage I-IV)
Time Frame: Average of 42 months
Average of 42 months
VAS score
Time Frame: Average of 42 months
Pain evaluated at rest, in the morning, in the evening and during the night.
Average of 42 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2002

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

September 15, 2011

First Submitted That Met QC Criteria

September 27, 2011

First Posted (Estimate)

September 28, 2011

Study Record Updates

Last Update Posted (Estimate)

September 28, 2011

Last Update Submitted That Met QC Criteria

September 27, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 224-01077(REK)
  • REK (Other Identifier: Regional Etisk Komite)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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