Unimalleolar Versus Bimalleolar Fixation in Bi- or Trimalleolar Ankle Fracture

Unimalleolar Versus Bimalleolar Fixation in Bi- or Trimalleolar Ankle Fracture - A Randomized Clinical Trial

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.

Study Overview

• Status: Suspended
• Conditions: Trauma
• Intervention / Treatment: Procedure: Unimalleolar fixation; Procedure: Bimalleolar fixation

• Study Type: Interventional
• Enrollment (Anticipated): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Oulu, Finland, 90029
    • Oulu University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Foot and Ankle Outcome Score (FAOS)	FAOS, 5 subscales from 0-100, with higher scores indicating better function	2 years
A 100 mm Visual Analogue Scale for function and pain (VAS)	Range from 0 to 100, with higher scores indicating more severe pain	2 years
The RAND 36-Item Health Survey for health-related quality-of-life (RAND-36)	8 subscales from 0-100, with higher scores indicating better health-related quality of life	2 years
Talocrural joint congruence	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.	At two, four and 12 weeks, and at 2 years
Fracture healing	Fracture union is considered complete when the fracture line disappeared and conversely, those fractures with a visible fracture line are deemed non-unions.	2 years

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Oulu
• Investigators: Study Director: Harri J Pakarinen, MD, PhD, AP, Pohjois-Pohjanmaan sairaanhoitopiiri

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2026

Study Registration Dates

• First Submitted: December 21, 2012
• First Submitted That Met QC Criteria: December 21, 2012
• First Posted (Estimate): December 31, 2012

Study Record Updates

• Last Update Posted (Actual): November 2, 2022
• Last Update Submitted That Met QC Criteria: November 1, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Fracture; Ankle; Osteosynthesis; medial malleolus
• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Ankle Fractures
• Other Study ID Numbers: OYSnilkka-RCT4