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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT01757951
Other study ID # OYSnilkka-RCT4
Secondary ID
Status Suspended
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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