Pilon Fracture Reduction and Functional Outcome

AO Clinical Investigation and Publishing Documentation

Status: Completed

Conditions: Pilon Fracture of Tibia

Study type: Observational

Funder types: Other

Identifiers

NCT01316289

Pilon

Details and patient eligibility

About

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.

Full 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.

Enrollment: 117 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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