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Unimalleolar Versus Bimalleolar Fixation in Bi- or Trimalleolar Ankle Fracture

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ClinicalTrials.gov Identifier: NCT01757951
Recruitment Status : Active, not recruiting
First Posted : December 31, 2012
Last Update Posted : October 18, 2018
Sponsor:
Information provided by (Responsible Party):
Harri Pakarinen, University of Oulu

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 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 2020
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Olerud-Molander Ankle Score [ Time Frame: 2 years ]
    A validated, condition-specific, patient-reported measure of ankle fracture symptoms.


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

  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)



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01757951


Locations
Finland
Oulu University Hospital
Oulu, Finland, 90029
Sponsors and Collaborators
University of Oulu
Investigators
Study Director: Harri J Pakarinen, MD, PhD Pohjois-Pohjanmaan sairaanhoitopiiri

Responsible Party: Harri Pakarinen, MD, PhD, University of Oulu
ClinicalTrials.gov Identifier: NCT01757951     History of Changes
Other Study ID Numbers: OYSnilkka-RCT4
First Posted: December 31, 2012    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018

Keywords provided by Harri Pakarinen, University of Oulu:
Ankle
Fracture
medial malleolus
Osteosynthesis

Additional relevant MeSH terms:
Ankle Fractures
Fractures, Bone
Wounds and Injuries