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| Name | Class |
|---|---|
| Leiden University Medical Center | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fixation | Experimental | Patients with a medium-sized posterior fragment which will be treated by open reduction and internal fixation of all fractured malleoli. |
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| No fixation | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fixation | Device | Fixation of the posterior malleolus with lag-screws or platefixation (usually by Drittelrohr plate). |
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| Measure | Description | Time Frame |
|---|---|---|
| Functional outcome 1 year after surgery measured by the AAOS-questionnaire (functional outcome of ankle/hindfoot in 27 questions) | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Post-traumatic osteoarthritis 1 year after surgery measured by the Kellgren-Lawrence (1-4) score. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sander Verhage, Drs. | Contact | +31644847448 | sanverhage@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MCHaaglanden | Recruiting | The Hague | South Holland | 2512VA | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28231779 | Derived | 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. |
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| ID | Term |
|---|---|
| D064386 | Ankle Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D016512 | Ankle Injuries |
| D007869 | Leg Injuries |
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| NO Fixation | Other | NO Fixation of the posterior malleolus. |
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| Bronovo Ziekenhuis | Recruiting | The Hague | South Holland | Netherlands |
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| Haga ziekenhuis | Recruiting | The Hague | South Holland | Netherlands |
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