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Completed

NCT Number: NCT01441817

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

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.

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Key information

Conditions

Ankle Malleolus Fracture Bimalleolar Ankle Fractures Ankle Injuries Fracture of Ankle Fracture of Medial Malleolus Fractures, Bone Leg Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University Hospital

Oslo, 0424, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Internal fixation

Procedure

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2008
Study completion
2008
First posted
Sep 28, 2011
Registry last updated
Sep 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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