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

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: Ankle Malleolus Fracture Bimalleolar; Fracture of Medial Malleolus; Fracture of Ankle
• Intervention / Treatment: Procedure: Internal fixation

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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)	Average of 42 months
The Olerud Molander Ankle score (OMAS)	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)		Average of 42 months
VAS score	Pain evaluated at rest, in the morning, in the evening and during the night.	Average of 42 months

Collaborators and Investigators

• Sponsor: Oslo University Hospital

Study record dates

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: Wounds and Injuries; Fractures, Bone; Ankle Fractures
• Other Study ID Numbers: 224-01077(REK); REK (Registry Identifier: S-08546)