Back to resultsNon--operative Treatment of the Medial Malleolus in bi- and Trimalleolar Ankle Fractures
Primary Purpose
Ankle Malleolus Fracture Bimalleolar, Fracture of Medial Malleolus, Fracture of Ankle
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Internal fixation
Sponsored by
About this trial
This is an interventional treatment trial for Ankle Malleolus Fracture Bimalleolar
Eligibility Criteria
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.
Sites / Locations
- Oslo University Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Surgery
Arm Description
Outcomes
Primary Outcome Measures
American Orthopaedic Foot and Ankle Society ankle hind foot score (AOFAS)
The Olerud Molander Ankle score (OMAS)
Secondary Outcome Measures
Posttraumatic osteoarthritis (OA) according to the criteria of Magnusson (stage I-IV)
VAS score
Pain evaluated at rest, in the morning, in the evening and during the night.
Full Information
NCT ID
NCT01441817
First Posted
September 15, 2011
Last Updated
September 27, 2011
Sponsor
Oslo University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01441817
Brief Title
Non--operative Treatment of the Medial Malleolus in bi- and Trimalleolar Ankle Fractures
Official Title
Non--operative Treatment of the Medial Malleolus in bi- and Trimalleolar Ankle Fractures. A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oslo University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Malleolus Fracture Bimalleolar, Fracture of Medial Malleolus, Fracture of Ankle
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Surgery
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Internal fixation
Intervention Description
Internal fixation of the medial malleolus following open reduction and internal fixation of the lateral and, if required, posterior malleolus.
Primary Outcome Measure Information:
Title
American Orthopaedic Foot and Ankle Society ankle hind foot score (AOFAS)
Time Frame
Average of 42 months
Title
The Olerud Molander Ankle score (OMAS)
Time Frame
Average of 42 months
Secondary Outcome Measure Information:
Title
Posttraumatic osteoarthritis (OA) according to the criteria of Magnusson (stage I-IV)
Time Frame
Average of 42 months
Title
VAS score
Description
Pain evaluated at rest, in the morning, in the evening and during the night.
Time Frame
Average of 42 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
ZIP/Postal Code
0424
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
Non--operative Treatment of the Medial Malleolus in bi- and Trimalleolar Ankle Fractures
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