Pilon Fracture Reduction and Functional Outcome



Status:Completed
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:1/19/2018
Start Date:November 2011
End Date:March 2017

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Quality of Fracture Reduction and Its Influence on Functional Outcome in Patients With Pilon Fractures - a Prospective Multicenter Case Series

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.

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.

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
We found this trial at
5
sites
325 9th Ave
Seattle, Washington 98104
(206) 744-3300
Harborview Medical Center Harborview Medical Center is the only designated Level 1 adult and pediatric...
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Seattle, WA
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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Jackson, MS
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Indianapolis, Indiana 46202
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Indianapolis, IN
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Innsbruck,
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30 East 7th Street
Saint Paul, Minnesota 55101
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Saint Paul, MN
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