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

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ClinicalTrials.gov Identifier: NCT01441817
Recruitment Status : Completed
First Posted : September 28, 2011
Last Update Posted : September 28, 2011
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Ankle Malleolus Fracture Bimalleolar Fracture of Medial Malleolus Fracture of Ankle Procedure: Internal fixation Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Non--operative Treatment of the Medial Malleolus in bi- and Trimalleolar Ankle Fractures. A Randomized Controlled Trial
Study Start Date : May 2002
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. American Orthopaedic Foot and Ankle Society ankle hind foot score (AOFAS) [ Time Frame: Average of 42 months ]
  2. The Olerud Molander Ankle score (OMAS) [ Time Frame: Average of 42 months ]

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



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01441817


Locations
Norway
Oslo University Hospital
Oslo, Norway, 0424
Sponsors and Collaborators
Oslo University Hospital

Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01441817     History of Changes
Other Study ID Numbers: 224-01077(REK)
REK ( Other Identifier: 224-01077 )
First Posted: September 28, 2011    Key Record Dates
Last Update Posted: September 28, 2011
Last Verified: September 2011

Additional relevant MeSH terms:
Fractures, Bone
Ankle Fractures
Wounds and Injuries