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

NCT ID: NCT01441817

Last Updated: 2011-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-05-31

Study Completion Date

2008-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Ankle Malleolus Fracture Bimalleolar Fracture of Medial Malleolus Fracture of Ankle

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Surgery

Group Type OTHER

Internal fixation

Intervention Type PROCEDURE

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

Interventions

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Internal fixation

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Oslo University Hospital

Oslo, , Norway

Site Status

Countries

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Norway

Other Identifiers

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REK

Identifier Type: OTHER

Identifier Source: secondary_id

224-01077(REK)

Identifier Type: -

Identifier Source: org_study_id