Quality of Fracture Reduction and Its Influence on Functional Outcome in Patients With Pilon Fractures - a Prospective Multicenter Case Series
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 117
- Locations
- 9
- Primary Endpoint
- 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.
Study Overview
Brief 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.
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 Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
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.
Secondary Outcomes
- Surgical details(1 year)
- Pre- and postoperative treatment(1 year)
- To assess whether patient and surgeon expectations are met with regard to the trauma outcome(1 year)