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Clinical Trials/NCT04132076
NCT04132076
Unknown
Not Applicable

Treatment Outcome After Ankle Joint Surgeries

University Medical Centre Ljubljana1 site in 1 country200 target enrollmentApril 17, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteochondral Lesion of Talus
Sponsor
University Medical Centre Ljubljana
Enrollment
200
Locations
1
Primary Endpoint
Tegner activity score
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 17, 2019
End Date
January 2021
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Urban Brulc

Medical doctor, resident of orthopaedic surgery

University Medical Centre Ljubljana

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

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).

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.

Secondary Outcomes

  • Kellgren and Lawrence score(36 months after operation)

Study Sites (1)

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