Pilon Fracture Reduction and Functional Outcome

AO Clinical Investigation and Publishing Documentation117 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

117

Conditions

Pilon Fracture of Tibia

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (9)

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

Outcomes

Primary Outcomes

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.

The most important predictors of functional outcome after pilon fracture will be identified by evaluating the influence of radiologically assessed parameters of reduction quality and other factors (age, high/low energy trauma, AO fracture type, open/closed fracture, delay between trauma and definitive fracture fixation) on the FAAM. In parallel, the radiological parameters will also be validated with respect to their reliability.

Time frame: 2 years

Secondary Outcomes

Surgical details

* Length of surgery (skin-to-skin time) * Type of implant used * Use of bone graft * Soft tissue or wound-related procedures (eg, debridement, free flap, local flap, split skin graft)

Time frame: 1 year

Pre- and postoperative treatment

Perioperative management data will include documentation of the use of thromboprophylaxis or prophylactic antibiotics, therapeutic antibiotics and pain medication including nonsteroidal antiinflammatory drugs (NSAID).

Time frame: 1 year

To assess whether patient and surgeon expectations are met with regard to the trauma outcome

Trauma expectations factor (TEF) to assess the patient and surgeon expectations about the outcome of the treatment

Time frame: 1 year

Data from ClinicalTrials.gov

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