Total Knee Arthroplasty With Vitamin E Polyethylene

Permedica spa1 site in 1 country186 target enrollmentApril 12, 2022

ConditionsKnee Osteoarthritis

Overview

Phase: N/A
Intervention: Not specified
Conditions: Knee Osteoarthritis
Sponsor: Permedica spa
Enrollment: 186
Locations: 1
Primary Endpoint: Implant Survival for Aseptic Loosening
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

April 12, 2022

End Date

June 27, 2023

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Permedica spa

Responsible Party

Sponsor

Eligibility Criteria

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 7-year follow-up;
•Age ≥ 18 and \< 85 years;
•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.

Outcomes

Primary Outcomes

Implant Survival for Aseptic Loosening

Time Frame: 10-year follow-up

Kaplan-Meier cumulative survival with revision due to aseptic loosening as the end-point

Secondary Outcomes

Implant Survival for Any Reason(10-year follow-up)
Forgotten Joint Score (FJS-12)(At mean follow-up of 8.5 years and 8.3 years for Vitamin E and Polyethylene, respectively)
American Knee Society Score (KSS)(At mean follow-up of 8.5 years and 8.3 years for Vitamin E and Polyethylene, respectively)
Periprosthetic Radiolucent Line(At mean follow-up of 8.5 years and 8.3 years for Vitamin E and Polyethylene, respectively)
Periprosthetic Osteolysis(At mean follow-up of 8.5 years and 8.3 years for Vitamin E and Polyethylene, respectively)