Overview

This trial is active, not recruiting.

Condition pilon fracture of tibia
Sponsor AO Clinical Investigation and Documentation
Start date November 2011
End date June 2016
Trial size 117 participants
Trial identifier NCT01316289, Pilon

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective

Primary Outcomes

Measure
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.
time frame: 2 years

Secondary Outcomes

Measure
Surgical details
time frame: 1 year
Pre- and postoperative treatment
time frame: 1 year
To assess whether patient and surgeon expectations are met with regard to the trauma outcome
time frame: 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Quality of Fracture Reduction and Its Influence on Functional Outcome in Patients With Pilon Fractures - a Prospective Multicenter Case Series
Principal investigator Christoph Sommer, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by AO Clinical Investigation and Documentation.