Treatment Outcome After Ankle Joint Surgeries

NCT04132076 | Unknown

• 1 other identifier: 0120-99/2019/4
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• FAOS questionnaire

  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

  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

  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 Outcomes (1)

• Kellgren and Lawrence score

  36 months after operation

Study Arms (4)

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.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

Department of orthopaedic surgery, University medical centre Ljubljana

Ljubljana, 1000, Slovenia

Location

Related Publications (1)

• Kolar M, Brulc U, Strazar K, Drobnic M. Patient-reported joint status and quality of life in sports-related ankle disorders and osteoarthritis. Int Orthop. 2021 Apr;45(4):1049-1055. doi: 10.1007/s00264-020-04747-y. Epub 2020 Sep 17.

  PMID: 32944803 DERIVED

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor, resident of orthopaedic surgery

Study Record Dates

• First Submitted: October 13, 2019
• First Posted: October 18, 2019
• Study Start: April 17, 2019
• Primary Completion: March 1, 2020
• Study Completion: January 1, 2021
• Last Updated: October 18, 2019

Record last verified: 2019-10

Locations

SL (1)