Pilon Fracture Reduction and Functional Outcome
This trial is active, not recruiting.
|Condition||pilon fracture of tibia|
|Sponsor||AO Clinical Investigation and Documentation|
|Start date||November 2011|
|End date||June 2016|
|Trial size||117 participants|
|Trial identifier||NCT01316289, Pilon|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Indianapolis, IN||Indiana Orthopaedic Hospital||no longer recruiting|
|St. Paul, MN||University of Minnesota||no longer recruiting|
|Jackson, MS||University of Mississippi Medical Center||no longer recruiting|
|Seattle, WA||Harborview Medical Center||no longer recruiting|
|Innsbruck, Austria||Medical University Innsbruck||no longer recruiting|
|Cerqueira Cesar - Sao Paulo, Brazil||Universidade de São Paulo - Faculdade de Medicina||no longer recruiting|
|Chur, Switzerland||Cantonal Hospital Graubuenden||no longer recruiting|
|Luzern, Switzerland||Cantonal Hospital Luzern||no longer recruiting|
|Winterthur, Switzerland||Cantonal Hospital Winterthur||no longer recruiting|
|Observational model||case control|
Examine the influence of reduction quality on the primary functional outcome (as assessed using the Foot and Ankle Ability Measure (FAAM)) of patients with pilon fractures treated with plate fixation.
time frame: 2 years
time frame: 1 year
Pre- and postoperative treatment
time frame: 1 year
To assess whether patient and surgeon expectations are met with regard to the trauma outcome
time frame: 1 year
Male or female participants at least 18 years old.
Inclusion Criteria: - 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 Exclusion Criteria: - 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
|Official title||Quality of Fracture Reduction and Its Influence on Functional Outcome in Patients With Pilon Fractures - a Prospective Multicenter Case Series|
|Principal investigator||Christoph Sommer, MD|
|Description||A prospective case series to 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. Radiological parameters including single/combined alignment and various articular measurements will also be validated according to their reliability. The sensitivity of the effects of reduction quality on functional outcome, and an extended evaluation of patient-rated functional and social outcomes as well as their outcome expectations will also be assessed as part of the secondary study aims.|
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