Total Knee Arthroplasty With Vitamin E Polyethylene

Study Overview
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Brief Summary
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The aim of this observational study is to investigate if there is any difference in survival rate, clinical and radiological results after total knee replacement with vitamin E-blended polyethylene in comparison to conventional polyethylene at minimum 7-year follow-up

Official Title
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Total Knee Arthroplasty With Vitamin E Polyethylene

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Device: GKS Prime Flex Mobile knee


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient who received primary cemented total knee arthroplasty with GKS Prime Flex Mobile knee by Permedica Orthopaedics with vitamin E polyethylene bearing or with conventional polyethylene bearing. Minimum 5-year follow-up; Patient who signed informed consent Exclusion Criteria: Patient who received primary cemented total knee arthroplasty with a different knee prosthetic design; Patient already enrolled in other clinical studies.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| VITAMIN E<br>Patients who received cemented total knee arthroplasty with vitamin E blended polyethylene mobile bearing | Device: GKS Prime Flex Mobile knee<br>* Total knee arthroplasty with a cemented mobile bearing bicompartmental knee prosthesis<br>|
| POLYETHYLENE<br>Patients who received cemented total knee arthroplasty with conventional polyethylene mobile bearing | Device: GKS Prime Flex Mobile knee<br>* Total knee arthroplasty with a cemented mobile bearing bicompartmental knee prosthesis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant survival for any reason | Kaplan-Meier cumulative survival with revision due to any reason as the end-point | Minimum follow-up of 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant survival for aseptic loosening | Kaplan-Meier cumulative survival with revision due to aseptic loosening as the end-point | Minimum follow-up of 5 years | 
| Forgotten Joint Score (FJS-12) | Patient related outcome measurement scored from 0 to 100 (higher scores mean better outcomes) | Minimum follow-up of 5 years | 
| American Knee Society Score (KSS) | Clinical and Functional knee score. Both sections are scored from 0 to 100 (higher scores mean better outcomes) | Minimum follow-up of 5 years | 
| Periprosthetic radiolucent line | Radiographic sign of bone remodelling around the implant | Minimum follow-up of 5 years | 
| Periprosthetic osteolysis | Radiographic sign of focal bone resorption around the implant | Minimum follow-up of 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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total knee arthroplasty, vitamin E, polyethylene, aseptic loosening, osteolysis