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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05094258
Other study ID # 61813471876
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 1, 2020
Est. completion date November 1, 2022

Study information

Verified date November 2021
Source Bezmialem Vakif University
Contact Volkan Ezici
Phone 00905331508025
Email volkanezicimd@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Comparison of the early clinical and radiological results and patient satisfaction of the mobile and fixed insert unicondylar knee prostheses routinely used in the clinic.


Description:

Unicondylar knee prosthesis operation will be performed on patients with unicompartmental knee arthrosis who apply to our clinic. Patients will be randomized to use mobile or fixed inserts. After 1 year of follow-up, SF-36, KOOS and HSS scores will be taken to examine the clinical satisfaction of the patients. In addition, radiological evaluation will be made for the presence of osteolysis at the tibial implant interface between both groups.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date November 1, 2022
Est. primary completion date December 1, 2021
Accepts healthy volunteers No
Gender All
Age group 45 Years to 75 Years
Eligibility Inclusion Criteria: - Patients with degenerative knee arthritis with only one compartment affected Exclusion Criteria: - Inflammatory Arthritis - Tricompartmental arthritis - Patients with fixed varus deformity greater than -10 degrees - Patients with fixed valgus deformity greater than -5 degrees - Patients with knee range of motion less than 90 degrees - Patients with more than 10 degrees of flexion contracture"

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
unicondylar knee prosthesis with mobile insert
Patients with unicondylar knee replacement using the mobile insert option
unicondylar knee prosthesis with fixed insert
Patients with unicondylar knee replacement using the fixed insert option

Locations

Country Name City State
Turkey Volkan Ezici Istanbul Fatih

Sponsors (1)

Lead Sponsor Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Short Form Health Survey (SF-36) SF-36 Score (0-100) to assess patient satisfaction at postoperative 1st year 0-1 year
Primary Knee injury and osteoarthritis outcome score (KOOS) Knee injury and osteoarthritis outcome score (0-100) 0-1 year
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