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Treatment Outcome After Ankle Joint Surgeries

Treatment Outcome After Ankle Joint Surgeries

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04132076
Enrollment
200
Registered
2019-10-18
Start date
2019-04-17
Completion date
2021-01-31
Last updated
2019-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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.

Interventions

None listed

Sponsors

University Medical Centre Ljubljana
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
FAOS questionnaire36 months after operationFoot 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 questionnaire36 months after operationEQ-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 score36 months after operationTegner 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.

Secondary

MeasureTime frameDescription
Kellgren and Lawrence score36 months after operationKellgren 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

Countries

Slovenia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026