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Unimalleolar Versus Bimalleolar Fixation in Bi- or Trimalleolar Ankle Fracture

This study is currently recruiting participants.
Verified December 2012 by University of Oulu
Sponsor:
Information provided by (Responsible Party):
Harri Pakarinen, University of Oulu
ClinicalTrials.gov Identifier:
NCT01757951
First received: December 21, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  Purpose

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 Intervention
Trauma
 Procedure: Talocrural joint is stable after fixation of medial malleolus. Patient is then randomized

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Unimalleolar Versus Bimalleolar Fixation in Bi- or Trimalleolar Ankle Fracture - A Randomized Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Oulu:

Primary Outcome Measures:
  • Rand-36 [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Olerud-Molander Score [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Talocrural joint congruence [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Fracture healing [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • VAS [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 126
Study Start Date: February 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Harri Pakarinen, MD, PhD, University of Oulu
ClinicalTrials.gov Identifier: NCT01757951     History of Changes
Other Study ID Numbers: OYSnilkka-RCT4
Study First Received: December 21, 2012
Last Updated: December 21, 2012
Health Authority: Finland: Ethics Committee

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

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on May 23, 2013