Unimalleolar Versus Bimalleolar Fixation in Bi- or Trimalleolar Ankle Fracture

• ClinicalTrials.gov Identifier: NCT01757951
• Recruitment Status: Suspended
• First Posted: December 31, 2012
• Last Update Posted: November 2, 2022
• Sponsor: University of Oulu
• Information provided by (Responsible Party): Harri Pakarinen, University of Oulu

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Trauma	Procedure: Unimalleolar fixation; Procedure: Bimalleolar fixation	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 126 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Unimalleolar Versus Bimalleolar Fixation in Bi- or Trimalleolar Ankle Fracture - A Randomized Clinical Trial
• Study Start Date: February 2012
• Estimated Primary Completion Date: December 2024
• Estimated Study Completion Date: December 2026

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Procedure: 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.
Active Comparator: 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.	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.

Outcome Measures

Primary Outcome Measures :

1. Olerud-Molander Ankle Score [ Time Frame: 2 years ]
   A validated, condition-specific, patient-reported measure of ankle fracture symptoms. Range from 0 to 100 points, with higher scores indicating better function

Secondary Outcome Measures :

1. The Foot and Ankle Outcome Score (FAOS) [ Time Frame: 2 years ]
   FAOS, 5 subscales from 0-100, with higher scores indicating better function
2. A 100 mm Visual Analogue Scale for function and pain (VAS) [ Time Frame: 2 years ]
   Range from 0 to 100, with higher scores indicating more severe pain
3. The RAND 36-Item Health Survey for health-related quality-of-life (RAND-36) [ Time Frame: 2 years ]
   8 subscales from 0-100, with higher scores indicating better health-related quality of life
4. Talocrural joint congruence [ Time Frame: At two, four and 12 weeks, and at 2 years ]
   Medial clear space < 4 mm and ≤ 1 mm wider than the superior clear space as measured between the lateral border of the medial malleolus and the medial border of the talus at the level of the talar dome.
5. Fracture healing [ Time Frame: 2 years ]
   Fracture union is considered complete when the fracture line disappeared and conversely, those fractures with a visible fracture line are deemed non-unions.

Other Outcome Measures:

1. Complications and Harms [ Time Frame: At two, four and 12 weeks, and at 2 years ]
   Treatment related complications and harms (i.e. wound infection, re-operations, deep vein trombhosis, plaster sore, wound healing problems)

Eligibility Criteria

• Ages Eligible for Study: 16 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Finland

Oulu University Hospital

Oulu, Finland, 90029

Sponsors and Collaborators

University of Oulu

Investigators

• Study Director: Harri J Pakarinen, MD, PhD, AP; Pohjois-Pohjanmaan sairaanhoitopiiri

More Information

• Responsible Party: Harri Pakarinen, MD, PhD, University of Oulu
• ClinicalTrials.gov Identifier: NCT01757951
• Other Study ID Numbers: OYSnilkka-RCT4
• First Posted: December 31, 2012
• Last Update Posted: November 2, 2022
• Last Verified: November 2022

Keywords provided by Harri Pakarinen, University of Oulu:

Ankle; Fracture; medial malleolus; Osteosynthesis

Additional relevant MeSH terms:

Ankle Fractures; Fractures, Bone; Wounds and Injuries