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

Trimalleolar Fracture Clinical Trial

— 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02596529
• Other study ID #: NL45763.098.13
• Status: Recruiting
• Phase: N/A
• First received: November 3, 2015
• Last updated: September 12, 2016
• Start date: January 2014

Study information

• Verified date: September 2016
• Source: Medical Center Haaglanden
• Contact: Sander Verhage, Drs.
• Phone: +31644847448
• Email: sanverhage[@]hotmail.com
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankle Fractures
• Fractures, Bone
• Open Reduction and Internal Fixation
• Posterior Malleolus
• Trimalleolar Fracture

Intervention

Device:
• Fixation
Fixation of the posterior malleolus with lag-screws or platefixation (usually by Drittelrohr plate).

Other:
• NO Fixation
NO Fixation of the posterior malleolus.

Locations

Country	Name	City	State
Netherlands	Bronovo Ziekenhuis	The Hague	Zuid-Holland
Netherlands	Haga ziekenhuis	The Hague	Zuid-Holland
Netherlands	MCHaaglanden	The Hague	Zuid-Holland

Sponsors (2)

Lead Sponsor	Collaborator
Medical Center Haaglanden	Leiden University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional outcome 1 year after surgery measured by the AAOS-questionnaire (functional outcome of ankle/hindfoot in 27 questions)		1 year	No
Secondary	Post-traumatic osteoarthritis 1 year after surgery measured by the Kellgren-Lawrence (1-4) score.		1 year	No

External Links

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