Treatment Outcome After Ankle Joint Surgeries

Sponsor
University Medical Centre Ljubljana (Other)
Overall Status
Unknown status
CT.gov ID
NCT04132076
Collaborator
(none)
200
1
20.5
9.7

Study Details

Study Description

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Treatment Outcome After Ankle Joint Surgeries
Actual Study Start Date :
Apr 17, 2019
Anticipated Primary Completion Date :
Mar 1, 2020
Anticipated Study Completion Date :
Jan 1, 2021

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. FAOS questionnaire [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 [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 [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of orthopaedic surgery, University medical centre Ljubljana Ljubljana Slovenia 1000

Sponsors and Collaborators

  • University Medical Centre Ljubljana

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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:
Oct 18, 2019
Last Update Posted:
Oct 18, 2019
Last Verified:
Oct 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 18, 2019