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

Not Applicable

• Conditions: Knee Osteoarthritis
• Interventions: Procedure: unicondylar knee prosthesis with mobile insert; Procedure: unicondylar knee prosthesis with fixed insert

• Registration Number: NCT05094258
• Lead Sponsor: Bezmialem Vakif University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2020-06-01
• Study First Submitted: 2021-10-13
• Study First Submitted QC: 2021-10-13
• Study First Posted: 2021-10-26
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-24
• Last Update Posted: 2021-11-30
• Primary Completion: 2021-12-01
• Study Completion: 2022-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mobile insert	unicondylar knee prosthesis with mobile insert	Unicondylar knee arthroplasty with mobile insert was applied to 30 patients determined by randomization. The patients were followed for 1 year.
fixed insert	unicondylar knee prosthesis with fixed insert	Unicondylar knee arthroplasty with fixed insert was applied to 30 patients determined by randomization. The patients were followed for 1 year.

Primary Outcome Measures

Name	Time	Method
Knee injury and osteoarthritis outcome score (KOOS)	0-1 year	Knee injury and osteoarthritis outcome score (0-100)
Short Form Health Survey (SF-36)	0-1 year	SF-36 Score (0-100) to assess patient satisfaction at postoperative 1st year

Trial Locations

Locations (1)

Volkan Ezici; 🇹🇷 Istanbul, Fatih, Turkey