Treatment Outcome After Ankle Joint Surgeries

October 17, 2019 updated by: Urban Brulc, University Medical Centre Ljubljana
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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Department of Orthopaedic surgery, University Medical Centre Ljubljana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
36 months after operation
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).
36 months after operation
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.
36 months after operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
36 months after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Centre Ljubljana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2019

Primary Completion (Anticipated)

March 1, 2020

Study Completion (Anticipated)

January 1, 2021

Study Registration Dates

First Submitted

October 13, 2019

First Submitted That Met QC Criteria

October 17, 2019

First Posted (Actual)

October 18, 2019

Study Record Updates

Last Update Posted (Actual)

October 18, 2019

Last Update Submitted That Met QC Criteria

October 17, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0120-99/2019/4

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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