MedTrace Logo

Fixation of the Posterior Malleolus in Trimalleolar AO Weber C Fractures.

NCT02599285 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 54

Last updated 2016-09-13

No results posted yet for this study

Summary

In AO Weber type C fractures, there is a combination of a proximal fibular fracture, a medial fracture or ruptured deltoid ligament, and a syndesmotic injury. Anatomical repair and reduction of the syndesmosis is essential to prevent diastasis in the ankle-joint. Widening and chronical instability of the syndesmosis is related to worse functional outcome and development of posttraumatic osteoarthritis in the ankle. There is limited biomechanical and clinical evidence that syndesmotic stability in AO Weber type C fractures with an additional posterior malleolar fracture can also be reached by fixation of the posterior malleolar fragment. Maybe, this is even superior to the usual treatment with syndesmotic positioning screws. Some authors concluded that stability of the syndesmosis in these fractures can be much more achieved by fixation of the posterior malleolar fragment than by placement of syndesmotic positioning screws alone. Another additional benefit of open reduction and fixation of the posterior malleolar fragment is that this will lead to an anatomical reconstruction of the syndesmosis. Although there is no current evidence, it is likely that a malreduction of the fibula in the tibial incisura will lead to a worse functional outcome on the long-term. No clear consensus in the literature is found as to which fragment size of the posterior malleolus should be internally fixed. The general opinion is that displaced fragments that involve more than 25% of the distal articular tibia should be fixed. 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 percutaneous 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.

Conditions

  • Trimalleolar Fracture
  • AO Weber C Fractures
  • Syndesmotic Stability
  • Open Reduction and Internal Fixation

Interventions

DEVICE

Fixation

Fixation of the posterior malleolus with lag-screws or plate-fixation. If syndesmosis is intra-operatively stable, no syndesmotic positioning screws will be placed.

DEVICE

NO Fixation

Posterior malleolus will not be fixated. Syndesmotic positioning screws will be placed.

Sponsors & Collaborators

  • Leiden University Medical Center

    collaborator OTHER

  • Medical Center Haaglanden

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2022-12-31

Countries

  • Netherlands

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02599285 on ClinicalTrials.gov