Unimalleolar Versus Bimalleolar Fixation in Bi- or Trimalleolar Ankle Fracture

Trauma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01757951
• Other study ID #: OYSnilkka-RCT4
• Status: Suspended
• Phase: N/A
• Start date: February 2012
• Est. completion date: December 2026

Study information

• Verified date: November 2022
• Source: University of Oulu
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 126
• Est. completion date: December 2026
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ankle Fractures
• Trauma

Intervention

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.
• 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.

Locations

Country	Name	City	State
Finland	Oulu University Hospital	Oulu

Sponsors (1)

Lead Sponsor	Collaborator
University of Oulu

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	The Foot and Ankle Outcome Score (FAOS)	FAOS, 5 subscales from 0-100, with higher scores indicating better function	2 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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