Treatment Outcome After Ankle Joint Surgeries
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|ClinicalTrials.gov Identifier: NCT04132076|
Recruitment Status : Enrolling by invitation
First Posted : October 18, 2019
Last Update Posted : October 18, 2019
|Condition or disease|
|Osteochondral Lesion of Talus Ankle Arthritis Instability; Ankle (Ligaments) (Old Injury) Impingement Syndrome of Ankle|
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Treatment Outcome After Ankle Joint Surgeries|
|Actual Study Start Date :||April 17, 2019|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||January 2021|
Group A: Osteochondral lesion of talus (OLT)
Patients with OLT treated operatively (debridement, microfracture, allograft, mesenchymal stem cells implantation) in Department of Orthopaedic Surgery, University Medical Centre Ljubljana (UMC).
Group B: Ankle joint osteoarthrosis
Patients with ankle joint osteoarthrosis treated operatively in Department of Orthopaedic Surgery, UMC Ljubljana.
Group C: Ankle Impingement syndrome
Patients with ankle impingement syndrome treated operatively in Department of Orthopaedic Surgery, UMC Ljubljana.
Group D: Ankle instability syndrome
Patients with ankle instability syndrome treated operatively in Department of Orthopaedic Surgery, UMC Ljubljana.
- FAOS questionnaire [ Time Frame: 36 months after operation ]Foot and Ankle Outcome Score (FAOS) is a patient reported instrument that may be useful for assessing changes in foot/ankle pathology over time, with or without treatment. It assesses patient pain (9 items), other symptoms (7 items), function in daily living (17 items), function in sport and recreation (5 items), and foot/ankle related quality of life (4 items). Scores range from 0 to 100 with a score of 0 indicating the worst possible foot/ankle symptoms and 100 indicating no foot/ankle symptoms.
- EQ-5D questionnaire [ Time Frame: 36 months after operation ]EQ-5D is a standardized instrument for measuring generic health status. Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scale used in the health state description part has three-level; having no problems, having some or moderate problems, being unable to do/having extreme problems. Rated level can be coded as a number 1, 2, or 3, which indicates having no problems for 1, having some problems for 2, and having extreme problems for 3. As a result, a person's health status can be defined by a 5-digit number, ranging from 11111 (having no problems in all dimensions) to 33333 (having extreme problems in all dimensions).
- Tegner activity score [ Time Frame: 36 months after operation ]Tegner activity score is a graduated list of activities of daily living, recreation, and competitive sports. The patient is asked to select the level of participation that best describes their current level of activity. The score varies from 0-10. A score of 0 represents sick leave or disability pension, whereas a score of 10 corresponds to participation in national and international elite competitive sports.
- Kellgren and Lawrence score [ Time Frame: 36 months after operation ]
Kellgren and Lawrence score is a common method of classifying the severity of osteoarthritis (OA) using five grades.
grade 0: no radiographic features of OA are present grade 1: doubtful joint space narrowing (JSN) and possible osteophytic lipping grade 2: definite osteophytes and possible JSN on anteroposterior weight-bearing radiograph grade 3: multiple osteophytes, definite JSN, sclerosis, possible bony deformity grade 4: large osteophytes, marked JSN, severe sclerosis and definite bony deformity
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04132076
|Department of orthopaedic surgery, University medical centre Ljubljana|
|Ljubljana, Slovenia, 1000|