Fixation of the Posterior Malleolus in Medium-sized Trimalleolar AO Weber-B Fractures. (POSTFIX)
Primary Purpose
Trimalleolar Fracture, Posterior Malleolus, Open Reduction and Internal Fixation
Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Fixation
NO Fixation
Sponsored by
About this trial
This is an interventional treatment trial for Trimalleolar Fracture
Eligibility 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.
Sites / Locations
- MCHaaglandenRecruiting
- Bronovo ZiekenhuisRecruiting
- Haga ziekenhuisRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Fixation
No fixation
Arm Description
Patients with a medium-sized posterior fragment which will be treated by open reduction and internal fixation of all fractured malleoli.
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.
Outcomes
Primary Outcome Measures
Functional outcome 1 year after surgery measured by the AAOS-questionnaire (functional outcome of ankle/hindfoot in 27 questions)
Secondary Outcome Measures
Post-traumatic osteoarthritis 1 year after surgery measured by the Kellgren-Lawrence (1-4) score.
Full Information
NCT ID
NCT02596529
First Posted
November 3, 2015
Last Updated
September 12, 2016
Sponsor
Medical Center Haaglanden
Collaborators
Leiden University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02596529
Brief Title
Fixation of the Posterior Malleolus in Medium-sized Trimalleolar AO Weber-B Fractures.
Acronym
POSTFIX
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 Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical Center Haaglanden
Collaborators
Leiden University Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trimalleolar Fracture, Posterior Malleolus, Open Reduction and Internal Fixation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fixation
Arm Type
Experimental
Arm Description
Patients with a medium-sized posterior fragment which will be treated by open reduction and internal fixation of all fractured malleoli.
Arm Title
No fixation
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Fixation
Intervention Description
Fixation of the posterior malleolus with lag-screws or platefixation (usually by Drittelrohr plate).
Intervention Type
Other
Intervention Name(s)
NO Fixation
Intervention Description
NO Fixation of the posterior malleolus.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Post-traumatic osteoarthritis 1 year after surgery measured by the Kellgren-Lawrence (1-4) score.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sander Verhage, Drs.
Phone
+31644847448
Email
sanverhage@hotmail.com
Facility Information:
Facility Name
MCHaaglanden
City
The Hague
State/Province
Zuid-Holland
ZIP/Postal Code
2512VA
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sander Verhage, Drs.
Phone
+31644847448
Email
sanverhage@hotmail.com
Facility Name
Bronovo Ziekenhuis
City
The Hague
State/Province
Zuid-Holland
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sander Verhage
Phone
0644847448
Email
sanverhage@hotmail.com
Facility Name
Haga ziekenhuis
City
The Hague
State/Province
Zuid-Holland
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sander Verhage
Phone
+31644847448
Email
sanverhage@hotmail.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
28231779
Citation
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.
Results Reference
derived
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Fixation of the Posterior Malleolus in Medium-sized Trimalleolar AO Weber-B Fractures.
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