Total Knee Arthroplasty With Vitamin E Polyethylene

Permedica spa186 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

186

Conditions

Knee Osteoarthritis

Interventions

GKS Prime Flex Mobile kneeDEVICE

Total knee arthroplasty with a cemented mobile bearing bicompartmental knee prosthesis

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (1)

Ospedale Centro Ortopedico di Quadrante

Omegna, Verbania, Italy

Outcomes

Primary Outcomes

Implant Survival for Aseptic Loosening

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

Time frame: 10-year follow-up

Secondary Outcomes

Implant Survival for Any Reason

Kaplan-Meier cumulative survival with revision due to any reason as the end-point

Time frame: 10-year follow-up

Forgotten Joint Score (FJS-12)

Patient related outcome measurement scored from 0 to 100 (higher scores mean better outcomes)

Time frame: At mean follow-up of 8.5 years and 8.3 years for Vitamin E and Polyethylene, respectively

American Knee Society Score (KSS)

Clinical and Functional scores of the knee. Both scores are scored from 0 to 100 (higher scores mean better outcomes)

Time frame: At mean follow-up of 8.5 years and 8.3 years for Vitamin E and Polyethylene, respectively

Periprosthetic Radiolucent Line

Radiographic sign of bone remodelling around the implant

Time frame: At mean follow-up of 8.5 years and 8.3 years for Vitamin E and Polyethylene, respectively

Periprosthetic Osteolysis

Radiographic sign of focal bone resorption around the implant

Time frame: At mean follow-up of 8.5 years and 8.3 years for Vitamin E and Polyethylene, respectively

Data from ClinicalTrials.gov

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