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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01441817
First received: September 15, 2011
Last updated: September 27, 2011
Last verified: September 2011
  Purpose

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 Intervention
Ankle Malleolus Fracture Bimalleolar
Fracture of Medial Malleolus
Fracture of Ankle
Procedure: Internal fixation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Non--operative Treatment of the Medial Malleolus in bi- and Trimalleolar Ankle Fractures. A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • American Orthopaedic Foot and Ankle Society ankle hind foot score (AOFAS) [ Time Frame: Average of 42 months ] [ Designated as safety issue: No ]
  • The Olerud Molander Ankle score (OMAS) [ Time Frame: Average of 42 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Posttraumatic osteoarthritis (OA) according to the criteria of Magnusson (stage I-IV) [ Time Frame: Average of 42 months ] [ Designated as safety issue: No ]
  • VAS score [ Time Frame: Average of 42 months ] [ Designated as safety issue: No ]
    Pain evaluated at rest, in the morning, in the evening and during the night.


Enrollment: 100
Study Start Date: May 2002
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Surgery Procedure: Internal fixation
Internal fixation of the medial malleolus following open reduction and internal fixation of the lateral and, if required, posterior malleolus.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01441817

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

No publications provided

Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01441817     History of Changes
Other Study ID Numbers: 224-01077(REK), REK
Study First Received: September 15, 2011
Last Updated: September 27, 2011
Health Authority: Norway: The Regional Ethics Committee for Medical Research

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on July 23, 2014