Pilon Fracture Reduction and Functional Outcome

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.

Study Overview

• Status: Completed
• Conditions: Pilon Fracture of Tibia

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.

• Study Type: Observational
• Enrollment (Actual): 117

Contacts and Locations

Study Locations

• Austria
  • Innsbruck, Austria, 6020
    • Medical University Innsbruck
• Brazil
  • CEP
    • São Paulo, CEP, Brazil, 05403-010
      • Universidade de São Paulo - Faculdade de Medicina
• Switzerland
  • Chur, Switzerland, 7000
    • Cantonal Hospital Graubuenden
  • Luzern, Switzerland, 6000
    • Cantonal Hospital Luzern
  • Winterthur, Switzerland, 8401
    • Cantonal Hospital Winterthur
• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana Orthopaedic Hospital
  • Minnesota
    • Saint Paul, Minnesota, United States, 55101
      • University of Minnesota
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Medical Center
  • Washington
    • Seattle, Washington, United States, 98104
      • Harborview Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with pilon fractures that fulfill the following inclusion and exclusion criteria

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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).	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	1 year

Collaborators and Investigators

• Sponsor: AO Clinical Investigation and Publishing Documentation
• Investigators: Principal Investigator: Christoph Sommer, MD, Cantonal Hospital Graubuenden; Study Director: Martin Schuler, PhD, AO Clinical Investigation and Documentation, Davos, Switzerland

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2011
• Primary Completion (ACTUAL): January 1, 2017
• Study Completion (ACTUAL): March 1, 2017

Study Registration Dates

• First Submitted: March 14, 2011
• First Submitted That Met QC Criteria: March 15, 2011
• First Posted (ESTIMATE): March 16, 2011

Study Record Updates

• Last Update Posted (ACTUAL): August 13, 2020
• Last Update Submitted That Met QC Criteria: August 11, 2020
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: functional outcome; tibial fractures; ankle joint; pilon; pilon fractures; tibial plafond; reduction quality; anatomical reduction
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Tibial Fractures
• Other Study ID Numbers: Pilon