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Clinical Trials/NCT05094258
NCT05094258
Unknown
Not Applicable

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

Bezmialem Vakif University1 site in 1 country60 target enrollmentJune 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Knee Osteoarthritis
Sponsor
Bezmialem Vakif University
Enrollment
60
Locations
1
Primary Endpoint
Knee injury and osteoarthritis outcome score (KOOS)
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2020
End Date
November 1, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Murat Sarikas

orthopaedic surgeon

Bezmialem Vakif University

Eligibility Criteria

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"

Outcomes

Primary Outcomes

Knee injury and osteoarthritis outcome score (KOOS)

Time Frame: 0-1 year

Knee injury and osteoarthritis outcome score (0-100)

Short Form Health Survey (SF-36)

Time Frame: 0-1 year

SF-36 Score (0-100) to assess patient satisfaction at postoperative 1st year

Study Sites (1)

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