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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Procedure: unicondylar knee prosthesis with mobile insert
* Procedure: unicondylar knee prosthesis with fixed insert


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients with medial knee arthrosis will be randomized to receive unicompartmental knee prosthesis using mobile inserts in 30 patients and fixed inserts in 30 patients. Patients will be evaluated after at least 1 year of follow-up
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: mobile insert<br>Unicondylar knee arthroplasty with mobile insert was applied to 30 patients determined by randomization. The patients were followed for 1 year. | Procedure: unicondylar knee prosthesis with mobile insert<br>* Patients with unicondylar knee replacement using the mobile insert option<br>|
| Active Comparator: fixed insert<br>Unicondylar knee arthroplasty with fixed insert was applied to 30 patients determined by randomization. The patients were followed for 1 year. | Procedure: unicondylar knee prosthesis with fixed insert<br>* Patients with unicondylar knee replacement using the fixed insert option<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Unicompartmental Knee osteoarthritis, Unicompartmental Knee prosthesis, Mobile insert, Fixed İnsert