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Unimalleolar Versus Bimalleolar Fixation in Bi- or Trimalleolar Ankle Fracture

Primary Purpose

Trauma

Status
Suspended
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Unimalleolar fixation
Bimalleolar fixation
Sponsored by
University of Oulu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trauma focused on measuring Ankle, Fracture, medial malleolus, Osteosynthesis

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Oulu University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Unimalleolar Fixation

Bimalleolar Fixation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The Foot and Ankle Outcome Score (FAOS)
FAOS, 5 subscales from 0-100, with higher scores indicating better function
A 100 mm Visual Analogue Scale for function and pain (VAS)
Range from 0 to 100, with higher scores indicating more severe pain
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
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.
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.

Full Information

First Posted
December 21, 2012
Last Updated
November 1, 2022
Sponsor
University of Oulu
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1. Study Identification

Unique Protocol Identification Number
NCT01757951
Brief Title
Unimalleolar Versus Bimalleolar Fixation in Bi- or Trimalleolar Ankle Fracture
Official Title
Unimalleolar Versus Bimalleolar Fixation in Bi- or Trimalleolar Ankle Fracture - A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Suspended
Why Stopped
Partly due to financial issues and changes in study staff work placements
Study Start Date
February 2012 (undefined)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oulu

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma
Keywords
Ankle, Fracture, medial malleolus, Osteosynthesis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
126 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Unimalleolar Fixation
Arm Type
Experimental
Arm Description
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.
Arm Title
Bimalleolar Fixation
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Unimalleolar fixation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Bimalleolar fixation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Olerud-Molander Ankle Score
Description
A validated, condition-specific, patient-reported measure of ankle fracture symptoms. Range from 0 to 100 points, with higher scores indicating better function
Time Frame
2 years
Secondary Outcome Measure Information:
Title
The Foot and Ankle Outcome Score (FAOS)
Description
FAOS, 5 subscales from 0-100, with higher scores indicating better function
Time Frame
2 years
Title
A 100 mm Visual Analogue Scale for function and pain (VAS)
Description
Range from 0 to 100, with higher scores indicating more severe pain
Time Frame
2 years
Title
The RAND 36-Item Health Survey for health-related quality-of-life (RAND-36)
Description
8 subscales from 0-100, with higher scores indicating better health-related quality of life
Time Frame
2 years
Title
Talocrural joint congruence
Description
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.
Time Frame
At two, four and 12 weeks, and at 2 years
Title
Fracture healing
Description
Fracture union is considered complete when the fracture line disappeared and conversely, those fractures with a visible fracture line are deemed non-unions.
Time Frame
2 years
Other Pre-specified Outcome Measures:
Title
Complications and Harms
Description
Treatment related complications and harms (i.e. wound infection, re-operations, deep vein trombhosis, plaster sore, wound healing problems)
Time Frame
At two, four and 12 weeks, and at 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harri J Pakarinen, MD, PhD, AP
Organizational Affiliation
Pohjois-Pohjanmaan sairaanhoitopiiri
Official's Role
Study Director
Facility Information:
Facility Name
Oulu University Hospital
City
Oulu
ZIP/Postal Code
90029
Country
Finland

12. IPD Sharing Statement

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Unimalleolar Versus Bimalleolar Fixation in Bi- or Trimalleolar Ankle Fracture

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