Unimalleolar Versus Bimalleolar Fixation in Bi- or Trimalleolar Ankle Fracture

NCT01757951 | Suspended DMC

• 1 other identifier: OYSnilkka-RCT4
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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

Keywords

Ankle; Fracture; medial malleolus; Osteosynthesis

Outcome Measures

Primary Outcomes (1)

• Olerud-Molander Ankle Score

  A validated, condition-specific, patient-reported measure of ankle fracture symptoms. Range from 0 to 100 points, with higher scores indicating better function

  2 years

Secondary Outcomes (5)

• The Foot and Ankle Outcome Score (FAOS)

  2 years

• A 100 mm Visual Analogue Scale for function and pain (VAS)

  2 years

• The RAND 36-Item Health Survey for health-related quality-of-life (RAND-36)

  2 years

• Talocrural joint congruence

  At two, four and 12 weeks, and at 2 years

• Fracture healing

  2 years

Other Outcomes (1)

• Complications and Harms

  At two, four and 12 weeks, and at 2 years

Study Arms (2)

Unimalleolar Fixation

EXPERIMENTAL

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.

Procedure: Unimalleolar fixation

Bimalleolar Fixation

ACTIVE COMPARATOR

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.

Procedure: Bimalleolar fixation

Interventions

Unimalleolar fixation 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.

Unimalleolar Fixation

Bimalleolar fixation 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.

Bimalleolar Fixation

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oulu: lead

Study Sites (1)

Oulu University Hospital

Oulu, 90029, Finland

Location

MeSH Terms

Conditions

Wounds and Injuries; Fractures, Bone

Study Officials

• Harri J Pakarinen, MD, PhD, AP

  Pohjois-Pohjanmaan sairaanhoitopiiri

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: December 21, 2012
• First Posted: December 31, 2012
• Study Start: February 1, 2012
• Primary Completion: December 1, 2024
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 2, 2022

Record last verified: 2022-11

Locations

FI (1)