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

Not Applicable

Completed

• Conditions: Ankle Malleolus Fracture Bimalleolar; Fracture of Medial Malleolus; Fracture of Ankle

• Registration Number: NCT01441817
• Lead Sponsor: Oslo University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-05
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Status Verified: 2011-09
• Study First Submitted: 2011-09-15
• Study First Submitted QC: 2011-09-27
• Last Update Submitted: 2011-09-27
• Study First Posted: 2011-09-28
• Last Update Posted: 2011-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Oslo University Hospital; 🇳🇴 Oslo, Norway