Treatment Outcome After Ankle Joint Surgeries

Ankle Arthritis Clinical Trial

Official title:

Treatment Outcome After Ankle Joint Surgeries

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04132076
• Other study ID #: 0120-99/2019/4
• Status: Enrolling by invitation
• Start date: April 17, 2019
• Est. completion date: January 2021

Study information

• Verified date: October 2019
• Source: University Medical Centre Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: January 2021
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Slovenia	Department of orthopaedic surgery, University medical centre Ljubljana	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Kellgren and Lawrence score	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