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.

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.

Study Overview

• Status: Unknown
• Conditions: Trimalleolar Fracture; Open Reduction and Internal Fixation; Posterior Malleolus
• Intervention / Treatment: Device: Fixation; Other: NO Fixation

• Study Type: Interventional
• Enrollment (Anticipated): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Zuid-Holland
    • The Hague, Zuid-Holland, Netherlands, 2512VA
      • Recruiting
      • MCHaaglanden
      • Contact: Sander Verhage, Drs.; Phone Number: +31644847448; Email: sanverhage@hotmail.com
    • The Hague, Zuid-Holland, Netherlands
      • Recruiting
      • Bronovo Ziekenhuis
      • Contact: Sander Verhage; Phone Number: 0644847448; Email: sanverhage@hotmail.com
    • The Hague, Zuid-Holland, Netherlands
      • Recruiting
      • Haga ziekenhuis
      • Contact: Sander Verhage; Phone Number: +31644847448; Email: sanverhage@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Functional outcome 1 year after surgery measured by the AAOS-questionnaire (functional outcome of ankle/hindfoot in 27 questions)	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Post-traumatic osteoarthritis 1 year after surgery measured by the Kellgren-Lawrence (1-4) score.	1 year

Collaborators and Investigators

• Sponsor: Medical Center Haaglanden
• Collaborators: Leiden University Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: November 3, 2015
• First Submitted That Met QC Criteria: November 3, 2015
• First Posted (Estimate): November 4, 2015

Study Record Updates

• Last Update Posted (Estimate): September 13, 2016
• Last Update Submitted That Met QC Criteria: September 12, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Ankle Fractures
• Other Study ID Numbers: NL45763.098.13