Unimalleolar Versus Bimalleolar Fixation in Bi- or Trimalleolar Ankle Fracture

NCT ID: NCT01757951

Last Updated: 2022-11-02

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2026-12-31

Brief Summary

A one third of all ankle fractures are bi- or trimalleolar. Traditionally these fractures are treated by both medial and lateral osteosynthesis, sometimes accompanied by osteosynthesis of the posterior malleolus. There is significant evidence that fractures of the lateral malleolus can be treated conservatively if the medial side is stable. However, there isn't a single study comparing standard bi- or trimalleolar fixation with only medial side osteosynthesis and postoperative immobilization with a cast.

Conditions

Trauma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Unimalleolar Fixation

Medial malleolus is fixed first and after that ankle mortise stability is assessed using external-rotation stress test. If talocrural joint is stable after fixation of medial malleolus, the patient is randomized to unimalleolar fixation group and no fixation of the lateral side is performed.

Group Type: EXPERIMENTAL

Unimalleolar fixation

Intervention Type: PROCEDURE

Medial malleolus is fixed first and after that ankle mortise stability is assessed using external-rotation stress test. If talocrural joint is stable after fixation of medial malleolus, the patient is randomized to unimalleolar fixation group and no fixation of the lateral side is performed.

Bimalleolar Fixation

Medial malleolus is fixed first and after that ankle mortise stability is assessed using external-rotation stress test. If talocrural joint is stable after fixation of medial malleolus, the patient is randomized to bimalleolar fixation group i.e. additional fixation of the lateral malleolus fracture is performed.

Group Type: ACTIVE_COMPARATOR

Bimalleolar fixation

Intervention Type: PROCEDURE

Medial malleolus is fixed first and after that ankle mortise stability is assessed using external-rotation stress test. If talocrural joint is stable after fixation of medial malleolus, the patient is randomized to bimalleolar fixation group i.e. additional fixation of the lateral malleolus fracture is performed.

Interventions

Unimalleolar fixation

Medial malleolus is fixed first and after that ankle mortise stability is assessed using external-rotation stress test. If talocrural joint is stable after fixation of medial malleolus, the patient is randomized to unimalleolar fixation group and no fixation of the lateral side is performed.

Intervention Type: PROCEDURE

Bimalleolar fixation

Medial malleolus is fixed first and after that ankle mortise stability is assessed using external-rotation stress test. If talocrural joint is stable after fixation of medial malleolus, the patient is randomized to bimalleolar fixation group i.e. additional fixation of the lateral malleolus fracture is performed.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Weber B bi- or trimalleolar ankle fracture (fracture of the lateral and medial malleolus +/- posterior malleolus sized under 30% of the distal tibia joint line measured from the lateral projection of the standard ankle radiographs)
• Age: 16 years or older
• Voluntary
• Operated within 7 days of the trauma
• Able to walk unaided before the current trauma

Exclusion Criteria

• Peripheral neuropathy
• Pilon fracture
• Bilateral ankle fracture
• Concomitant tibial fracture
• Pathological fracture
• Active infection around the ankle
• A previous ankle fracture on either side
• In trimalleolar fractures, posterior malleolus fracture sized over 30% of the distal tibia joint line measured from the lateral projection of the standard ankle radiographs
• Inadequate co-operation
• Permanent residence outside the catchment area of the study hospital

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oulu

OTHER

Sponsor Role: lead

Responsible Party

Harri Pakarinen

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Harri J Pakarinen, MD, PhD, AP

Role: STUDY_DIRECTOR

Pohjois-Pohjanmaan sairaanhoitopiiri

Locations

Oulu University Hospital

Oulu, , Finland

Countries

Finland

Other Identifiers

OYSnilkka-RCT4

Identifier Type: -

Identifier Source: org_study_id