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Pilon Fracture of Tibia | Pilon Fracture Reduction and Functional Outcome

Pilon Fracture of Tibia research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Pilon Fracture of Tibia

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Study Status

Completed

Start Date: November 2011

Completed Date: March 2017

Phase:

Type: Observational

Design:

Primary Outcome: 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.

Secondary Outcome: Surgical details

Study sponsors, principal investigator, and references

Principal Investigator: Christoph Sommer, MD

Lead Sponsor: AO Clinical Investigation and Documentation

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01316289

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