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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical details |
| 1 year |
| Pre- and postoperative treatment |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with pilon fractures that fulfill the following inclusion and exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Christoph Sommer, MD | Cantonal Hospital Graubuenden | Principal Investigator |
| Martin Schuler, PhD | AO Clinical Investigation and Documentation, Davos, Switzerland | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana Orthopaedic Hospital | Indianapolis | Indiana | 46202 | United States | ||
| University of Minnesota |
| ID | Term |
|---|---|
| D013978 | Tibial Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |
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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 |
| 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 |
| Saint Paul |
| Minnesota |
| 55101 |
| United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| Harborview Medical Center | Seattle | Washington | 98104 | United States |
| Medical University Innsbruck | Innsbruck | 6020 | Austria |
| Universidade de São Paulo - Faculdade de Medicina | São Paulo | CEP | 05403-010 | Brazil |
| Cantonal Hospital Graubuenden | Chur | 7000 | Switzerland |
| Cantonal Hospital Luzern | Lucerne | 6000 | Switzerland |
| Cantonal Hospital Winterthur | Winterthur | 8401 | Switzerland |