Treatment Outcome After Ankle Joint Surgeries

Study Overview
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Brief Summary
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Osteochondral lesion of talus (OLT), osteoarthrosis and impingement/instability syndrome are most common ankle joint pathologies. This study analyses outcome after various different operative treatment of aforementioned pathologies. Investigators hypothesis is that patient characteristics, type of lesion and surgical technique affect the result of treatment. The investigators will compare subjective (questionnaire) and objective (clinical examination) status of patient before and after operation.

Official Title
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Treatment Outcome After Ankle Joint Surgeries

Conditions
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Osteochondral Lesion of Talus, Ankle Arthritis, Instability; Ankle (Ligaments) (Old Injury), Impingement Syndrome of Ankle

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with OLT treated operatively in Department of Orthopaedic Surgery, UMC Ljubljana. Patients with ankle joint osteoarthritis treated operatively in Department of Orthopaedic Surgery, UMC Ljubljana. Patients with ankle instability syndrome treated operatively in Department of Orthopaedic Surgery, UMC Ljubljana. Patients with ankle impingement syndrome treated operatively in Department of Orthopaedic Surgery, UMC Ljubljana. Exclusion Criteria: patient refuse to participate in study no respond of patient after invitation to answer a standardized questionnaire (EQ-5D, FAOS, Tegner activity score) no respond of patient after invitation to control examination after operation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A: Osteochondral lesion of talus (OLT)<br>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<br>Patients with ankle joint osteoarthrosis treated operatively in Department of Orthopaedic Surgery, UMC Ljubljana. | |
| Group C: Ankle Impingement syndrome<br>Patients with ankle impingement syndrome treated operatively in Department of Orthopaedic Surgery, UMC Ljubljana. | |
| Group D: Ankle instability syndrome<br>Patients with ankle instability syndrome treated operatively in Department of Orthopaedic Surgery, UMC Ljubljana. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FAOS questionnaire | 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. | 36 months after operation | 
| EQ-5D questionnaire | 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). | 36 months after operation | 
| Tegner activity score | 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. | 36 months after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kellgren and Lawrence score | 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 | 36 months after operation |