Pilon Fracture Reduction and Functional Outcome

Completed

Conditions studied: Pilon Fracture of Tibia

In brief

This prospective case series will essentially examine the influence of reduction quality on the primary functional outcome (as assessed using the FAAM) of patients with pilon fractures treated with plate fixation. The plates used in this trial can be chosen according to the preferences of the surgeon.

Key facts

Study ID

NCT01316289

Run by

AO Clinical Investigation and Publishing Documentation

People needed

117

Starts

2011-11-01

Expected to finish

2017-03-01

Last updated by the study team

2020-08-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 years and older
• Patients with a unilateral intraarticular pilon fracture of the distal tibia classified according to AO: AO 43 - B1, B2 and B3 (partial intraarticular) AO 43 - C1, C2 and C3 (total intraarticular)
• Definitive fracture fixation with a plate within 4 weeks after accident (Temporary fixation with an external fixator, cast or traction is allowed)
• Signed written informed consent (by the patients) and agreement to attend the planned FU evaluations

You may not qualify if…

• Contralateral fracture of the distal half of the tibia/fibula/talus
• Pathologic fracture
• Severe Polytrauma: Injury Severity Score (ISS) > 28
• Preexisting severe vascular disease (chronic venous insufficiency, chronic arterial occlusive disease)
• Drug or alcohol abuse
• American Society of Anesthesiologists (ASA) class V and VI
• Inability to walk independently prior to injury event
• Neurological and psychiatric disorders that would preclude reliable assessment

Where it is running

• Indiana Orthopaedic Hospital — Indianapolis, Indiana, United States
• University of Minnesota — Saint Paul, Minnesota, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• Harborview Medical Center — Seattle, Washington, United States
• Medical University Innsbruck — Innsbruck, Austria
• Universidade de São Paulo - Faculdade de Medicina — São Paulo, CEP, Brazil
• Cantonal Hospital Graubuenden — Chur, Switzerland
• Cantonal Hospital Luzern — Lucerne, Switzerland
• Cantonal Hospital Winterthur — Winterthur, Switzerland

Full record on ClinicalTrials.gov

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