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Unimalleolar Versus Bimalleolar Fixation in Bi- or Trimalleolar Ankle Fracture

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ClinicalTrials.gov Identifier: NCT01757951
Recruitment Status : Unknown
Verified December 2012 by Harri Pakarinen, University of Oulu.
Recruitment status was:  Recruiting
First Posted : December 31, 2012
Last Update Posted : December 31, 2012
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Trauma Procedure: Talocrural joint is stable after fixation of medial malleolus. Patient is then randomized

Study Design

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 2014
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Unimalleolar Fixation
Talocrural joint is stable after fixation of medial malleolus. Patient is randomized to unimalleolar fixation group.
Procedure: Talocrural joint is stable after fixation of medial malleolus. Patient is then randomized
Active Comparator: Bimalleolar Fixation
Talocrural joint is stable after fixation of medial malleolus. Patient is randomized to bimalleolar fixation group.
Procedure: Talocrural joint is stable after fixation of medial malleolus. Patient is then randomized


Outcome Measures

Primary Outcome Measures :
  1. Rand-36 [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Olerud-Molander Score [ Time Frame: 2 years ]

Other Outcome Measures:
  1. Talocrural joint congruence [ Time Frame: 2 years ]
  2. Fracture healing [ Time Frame: 2 years ]
  3. VAS [ Time Frame: 2 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Weber B bi- or trimalleolar ankle fracture
  • Age: 16 years or older
  • Voluntary
  • Operated within 7 days of the trauma

Exclusion Criteria:

  • Peripheral neuropathy
  • Pilon fracture
  • Bilateral ankle fracture
  • Simultaneous crural fracture
  • Pathological fracture
  • Active infection around the ankle
  • A previous ankle fracture on either side
  • In trimalleolar fractures over 30% of the joint line is included in the posterior malleolus fragment
  • Lives outside our hospital district or a foreigner
  • Co-operation is insufficient
Contacts and Locations

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


Contacts
Contact: Simo S Nortunen, MD +35883152011 simo.nortunen@ppshp.fi
Contact: Harri J Pakarinen, MD, PhD +35883152011 harri.pakarinen@ppshp.fi

Locations
Finland
Oulu University Hospital Recruiting
Oulu, Finland, 90029
Contact: Simo S Nortunen, MD    +35883152011    simo.nortunen@ppshp.fi   
Contact: Harri J Pakarinen, MD, PhD    +35883152011    harri.pakarinen@ppshp.fi   
Sponsors and Collaborators
University of Oulu
Investigators
Study Director: Harri J Pakarinen, MD, PhD Pohjois-Pohjanmaan sairaanhoitopiiri
More Information

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: December 31, 2012
Last Verified: December 2012

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

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