Pilon Fracture Reduction and Functional Outcome

Pilon Fracture of Tibia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01316289
• Other study ID #: Pilon
• Status: Completed
• Start date: November 2011
• Est. completion date: March 2017

Study information

• Verified date: January 2018
• Source: AO Innovation Translation Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: March 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Pilon Fracture of Tibia
• Tibial Fractures

Locations

Country	Name	City	State
Austria	Medical University Innsbruck	Innsbruck
Brazil	Universidade de São Paulo - Faculdade de Medicina	São Paulo	CEP
Switzerland	Cantonal Hospital Graubuenden	Chur
Switzerland	Cantonal Hospital Luzern	Luzern
Switzerland	Cantonal Hospital Winterthur	Winterthur
United States	Indiana Orthopaedic Hospital	Indianapolis	Indiana
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	University of Minnesota	Saint Paul	Minnesota
United States	Harborview Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
AO Clinical Investigation and Publishing Documentation

Countries where clinical trial is conducted

United States,  Austria,  Brazil,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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

External Links

•   Link to the final publication