Total Knee Arthroplasty With Vitamin E Polyethylene

Permedica

Status: Completed

Conditions: Knee Osteoarthritis

Treatments: Device: GKS Prime Flex Mobile knee

Study type: Observational

Funder types: Industry

Identifiers

NCT05810285

VITALECOQ2020

Details and patient eligibility

About

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

Enrollment: 186 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

186 participants in 2 patient groups

VITAMIN E

Description:

Patients who received cemented total knee arthroplasty with vitamin E blended polyethylene mobile bearing

Treatment:

Device: GKS Prime Flex Mobile knee

POLYETHYLENE

Description:

Patients who received cemented total knee arthroplasty with conventional polyethylene mobile bearing

Treatment:

Device: GKS Prime Flex Mobile knee