Ankle Fractures
Conditions
Keywords
Arthroscopy, Ankle Fracture, Patient rated outcome
Brief summary
The aim of this study is to evaluate the intraarticular lesions, to identify fractures specifically at risk for these, and to assess the results following arthroscopically assisted open reduction and internal fixation of complex ankle fractures prospectively.
Detailed description
Starting 05/01/13 patients with complex ankle fractures, older than 17 years, who sustained the injury less than 14 days before surgery and giving informed consent are consecutively enrolled. A complex fracture is defined as either an isolated malleolar fracture in combination with ligamentous instability, or a bi- or trimalleolar fracture. An unstable ligamentous injury is defined as either a disruption of the deltoid ligament leading to increased medial talar tilt, or an unstable syndesmotic injury assessed by the external rotation test both after osteosynthesis of all fractures. Exclusion criteria are isolated unimalleolar fractures, pilon fractures, open fractures, multiple injuries, mental illness, incompliance or pregnancy. Data assessed are: * Demographics * Medical history * Classification (AO, Haraguchi, ICRS, location and size defect) * Surgery details * Complications * PROMs (FAAM, AOFAS, OMAS, FAOS, TAS, SF-12, EQ-5d, MoxFQ)
Interventions
PROCEDUREArthroscopic assisted ankle fracture treatment
Any complex ankle fracture, as discriped above, will be treated arthroscopically and will be prospectively followed-up using well validated PROMs
Sponsors
Ludwig-Maximilians - University of Munich
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Unimalleolar fracture + ligamentous injury * Bi- or trimalleolar fracture ± ligamentous injury * \> 17 years * Date of injury less than 15 days * Written informed consent
Exclusion criteria
* Isolated unimalleolar fracture * Pilon fracture * Open fracture * Mental illness, incompliance, pregnancy * Multiple injuries
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| OMAS | Through study completion, an average of 1 year | Olerud and Molander Ankle Score; Validated PROM; Range 0-100 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| FAAM | Through study completion, an average of 1 year | Foot and Ankle Ability Measure, Validated PROM; Range 0-100 |
| AOFAS | Through study completion, an average of 1 year | American Orthopaedic Foot and Ankle Society, Validated PROM; Range 0-100 |
| FAOS | Through study completion, an average of 1 year | Foot and Ankle Outcome Score, Validated PROM; Range 0-100 |
| ICRS: Clinical Cartilage Injury Evaluation System | IntraOP | Intraarticular cartilage lesions and treatment |
| SF-12 | Through study completion, an average of 1 year | Quality of life score, Validated PROM; Range 0-100 |
| EQ-5d | Through study completion, an average of 1 year | Quality of life score, Validated PROM; Range 0-100 |
| MoxFQ | Through study completion, an average of 1 year | The Manchester-Oxford Foot Questionnaire, Validated PROM; Range 0-100 |
| TAS | Through study completion, an average of 1 year | Tegener Activity Scale, Validated PROM; Range 0-10 |
Countries
Germany
Contacts
Primary ContactSebastian F Baumbach, MD
Backup ContactHans Polzer, MD
Outcome results
None listed