Fixation of the Posterior Malleolus in Medium-sized Trimalleolar AO Weber-B Fractures.
POSTFIX
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.
1 other identifier
interventional
84
1 country
3
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.
Trial Health
Trial Health Score
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participants targeted
Target at P50-P75 for not_applicable
3 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 3, 2015
CompletedFirst Posted
Study publicly available on registry
November 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedSeptember 13, 2016
September 1, 2016
4.9 years
November 3, 2015
September 12, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Functional outcome 1 year after surgery measured by the AAOS-questionnaire (functional outcome of ankle/hindfoot in 27 questions)
1 year
Secondary Outcomes (1)
Post-traumatic osteoarthritis 1 year after surgery measured by the Kellgren-Lawrence (1-4) score.
1 year
Study Arms (2)
Fixation
EXPERIMENTALPatients with a medium-sized posterior fragment which will be treated by open reduction and internal fixation of all fractured malleoli.
No fixation
ACTIVE COMPARATORPatients 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.
Interventions
Fixation of the posterior malleolus with lag-screws or platefixation (usually by Drittelrohr plate).
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medical Center Haaglandenlead
- Leiden University Medical Centercollaborator
Study Sites (3)
MCHaaglanden
The Hague, South Holland, 2512VA, Netherlands
Bronovo Ziekenhuis
The Hague, South Holland, Netherlands
Haga ziekenhuis
The Hague, South Holland, Netherlands
Related Publications (1)
Verhage S, van der Zwaal P, Bronkhorst M, van der Meulen H, Kleinveld S, Meylaerts S, Rhemrev S, Krijnen P, Schipper I, Hoogendoorn J. Medium-sized posterior fragments in AO Weber-B fractures, does open reduction and fixation improve outcome? the POSTFIX-trial protocol, a multicenter randomized clinical trial. BMC Musculoskelet Disord. 2017 Feb 23;18(1):94. doi: 10.1186/s12891-017-1445-0.
PMID: 28231779DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
November 3, 2015
First Posted
November 4, 2015
Study Start
January 1, 2014
Primary Completion
December 1, 2018
Last Updated
September 13, 2016
Record last verified: 2016-09