Clinical trial NCT01316289: Pilon Fracture Reduction and Functional Outcome
Official title: Quality of Fracture Reduction and Its Influence on Functional Outcome in Patients With Pilon Fractures - a Prospective Multicenter Case Series
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pilon Fracture of Tibia
Keywords: tibial fractures
pilon
pilon fractures
tibial plafond
reduction quality
anatomical reduction
functional outcome
ankle joint
Lead sponsor: AO Innovation Translation Center
Sponsor class: OTHER
First posted: 2011-03-16
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with pilon fractures that fulfill the following inclusion and exclusion criteria

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 2 years
Secondary outcomes:
measure: Surgical details
timeFrame: 1 year
measure: Pre- and postoperative treatment
timeFrame: 1 year
measure: To assess whether patient and surgeon expectations are met with regard to the trauma outcome
timeFrame: 1 year
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana Orthopaedic Hospital
state: Indiana
city: Saint Paul
country: United States
facility: University of Minnesota
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
city: Innsbruck
country: Austria
facility: Medical University Innsbruck
city: São Paulo
country: Brazil
facility: Universidade de São Paulo - Faculdade de Medicina
state: CEP
city: Chur
country: Switzerland
facility: Cantonal Hospital Graubuenden
city: Luzern
country: Switzerland
facility: Cantonal Hospital Luzern
city: Winterthur
country: Switzerland
facility: Cantonal Hospital Winterthur
Study officials:
affiliation: Cantonal Hospital Graubuenden
name: Christoph Sommer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AO Clinical Investigation and Documentation, Davos, Switzerland
name: Martin Schuler, PhD
role: STUDY_DIRECTOR
References: