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Treatment Outcome After Ankle Joint Surgeries

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04132076
Recruitment Status : Enrolling by invitation
First Posted : October 18, 2019
Last Update Posted : October 18, 2019
Sponsor:
Information provided by (Responsible Party):
Urban Brulc, University Medical Centre Ljubljana

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.

Condition or disease
Osteochondral Lesion of Talus Ankle Arthritis Instability; Ankle (Ligaments) (Old Injury) Impingement Syndrome of Ankle

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Retrospective
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/Cohort
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.



Primary Outcome Measures :
  1. 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.

  2. 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).

  3. 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.


Secondary Outcome Measures :
  1. 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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The invetigators will analyse cohort of patient after ankle joint surgery in the Department of Orthopaedic Surgery, UMC Ljubljana between 2008 and 2018.
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

Information from the National Library of Medicine

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


Locations
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Slovenia
Department of orthopaedic surgery, University medical centre Ljubljana
Ljubljana, Slovenia, 1000
Sponsors and Collaborators
University Medical Centre Ljubljana

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Responsible Party: Urban Brulc, Medical doctor, resident of orthopaedic surgery, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT04132076    
Other Study ID Numbers: 0120-99/2019/4
First Posted: October 18, 2019    Key Record Dates
Last Update Posted: October 18, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Joint Diseases
Musculoskeletal Diseases