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Fixation of the Posterior Malleolus in Medium-sized Trimalleolar AO Weber-B Fractures. (POSTFIX)

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ClinicalTrials.gov Identifier: NCT02596529
Recruitment Status : Unknown
Verified September 2016 by Jochem Hoogendoorn, Medical Center Haaglanden.
Recruitment status was:  Recruiting
First Posted : November 4, 2015
Last Update Posted : September 13, 2016
Sponsor:
Collaborator:
Leiden University Medical Center
Information provided by (Responsible Party):
Jochem Hoogendoorn, Medical Center Haaglanden

Brief Summary:
The optimal treatment of ankle fractures with involvement of the posterior malleolus remains a subject of debate. Despite a large amount of literature on the role of the posterior malleolus in a so-called trimalleolar fracture, there are no clear guidelines for its treatment. Its size is the leading indication whether fixation of the fragment is necessary or not. Most orthopedic surgeons consider a posterior malleolar fracture fragment larger than 25% to 33% an indication for fixation. Interestingly, after careful evaluation of the available literature, there does not seem to be hard evidence for these numbers. It is generally accepted that restoration of a normal anatomic mortise and normal tibiotalar contact area are key elements for a good functional outcome. Inadequate reduction of the posterior fragment may alter the tibiotalar contact area and the joint biomechanics with altered stresses in parts of the joint, leading to the development of osteoarthritis and worse functional outcome. Traditionally, reduction of these larger fragments is indirectly, followed by percutaneous screw fixation in anterior-posterior direction. Disadvantages are that it is hard to achieve an anatomical reduction, and that fixation of smaller fragments is very difficult. Recently, a direct exposure of the posterior tibia via a posterolateral approach in prone position, followed by open reduction and fixation with screws in posterior-anterior direction or antiglide plate is advocated by several authors. This approach allows perfect visualization of the fracture, articular anatomical reduction, and strong fixation. Another advantage is that even small posterior fragments can be addressed. Several case series are published, which describe minimal major wound complications, good functional outcomes, and minimal need for reoperation. Since 2 years, in our institution we perform an open, anatomical reduction and fixation of all medium-sized posterior fragments via this approach. Although not thoroughly investigated yet, it seems to lead to better clinical outcomes than described in the literature and our retrospective cohort study.

Condition or disease Intervention/treatment Phase
Trimalleolar Fracture Posterior Malleolus Open Reduction and Internal Fixation Device: Fixation Other: NO Fixation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Medium-sized Posterior Fragments in AO-Weber B Fractures, Does Open Reduction and Internal Fixation Improve Outcome? A Multicenter Randomized Controlled Trial. The POSTFIX-trial.
Study Start Date : January 2014
Estimated Primary Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arm Intervention/treatment
Experimental: Fixation
Patients with a medium-sized posterior fragment which will be treated by open reduction and internal fixation of all fractured malleoli.
Device: Fixation
Fixation of the posterior malleolus with lag-screws or platefixation (usually by Drittelrohr plate).

Active Comparator: No fixation
Patients with a medium-sized posterior fragment which will be treated bij open reduction and internal fixation of lateral and medial malleolus alone. No fixation of the posterior malleolus take place.
Other: NO Fixation
NO Fixation of the posterior malleolus.




Primary Outcome Measures :
  1. Functional outcome 1 year after surgery measured by the AAOS-questionnaire (functional outcome of ankle/hindfoot in 27 questions) [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Post-traumatic osteoarthritis 1 year after surgery measured by the Kellgren-Lawrence (1-4) score. [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 18 and 70 years old
  • First ankle fracture of the affected side.
  • Trimalleolar AO-Weber B fracture with additional medium-sized posterior fragment (5-25% of involved articular surface, AO type 44-B3)

Exclusion Criteria:

  • severe traumatized patients
  • Multiple fractures during visit emergency department
  • Ankle fracture of the same ankle in the history
  • Patients with pre-existent mobility problems
  • Pre-existent disability
  • Patients living in another region and follow-up will take place in another hospital.
  • Inability to speak the dutch language.

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): NCT02596529


Contacts
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Contact: Sander Verhage, Drs. +31644847448 sanverhage@hotmail.com

Locations
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Netherlands
MCHaaglanden Recruiting
The Hague, Zuid-Holland, Netherlands, 2512VA
Contact: Sander Verhage, Drs.    +31644847448    sanverhage@hotmail.com   
Bronovo Ziekenhuis Recruiting
The Hague, Zuid-Holland, Netherlands
Contact: Sander Verhage    0644847448    sanverhage@hotmail.com   
Haga ziekenhuis Recruiting
The Hague, Zuid-Holland, Netherlands
Contact: Sander Verhage    +31644847448    sanverhage@hotmail.com   
Sponsors and Collaborators
Medical Center Haaglanden
Leiden University Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jochem Hoogendoorn, Dr., Medical Center Haaglanden
ClinicalTrials.gov Identifier: NCT02596529    
Other Study ID Numbers: NL45763.098.13
First Posted: November 4, 2015    Key Record Dates
Last Update Posted: September 13, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Fractures, Bone
Ankle Fractures
Wounds and Injuries