Comparison of Early Results of Mobile and Fixed Insert Unicondylar Knee Prosthesis.

Knee Osteoarthritis Clinical Trial

Official title:

Comparison of Early Clinical and Radiological Results and Patient Satisfaction of Mobile and Fixed Insert Unicondylar Knee Prosthesis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05094258
• Other study ID #: 61813471876
• Status: Recruiting
• Phase: N/A
• 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
• 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"

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

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