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

Fracture of Ankle Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01441817
• Other study ID #: 224-01077(REK)
• Secondary ID: REK
• Status: Completed
• Phase: N/A
• First received: September 15, 2011
• Last updated: September 27, 2011
• Start date: May 2002
• Est. completion date: August 2008

Study information

• Verified date: September 2011
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: The Regional Ethics Committee for Medical Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankle Fractures
• Ankle Malleolus Fracture Bimalleolar
• Fracture of Ankle
• Fracture of Medial Malleolus
• Fractures, Bone

Intervention

Procedure:
• Internal fixation
Internal fixation of the medial malleolus following open reduction and internal fixation of the lateral and, if required, posterior malleolus.

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	American Orthopaedic Foot and Ankle Society ankle hind foot score (AOFAS)		Average of 42 months	No
Primary	The Olerud Molander Ankle score (OMAS)		Average of 42 months	No
Secondary	Posttraumatic osteoarthritis (OA) according to the criteria of Magnusson (stage I-IV)		Average of 42 months	No
Secondary	VAS score	Pain evaluated at rest, in the morning, in the evening and during the night.	Average of 42 months	No