Total Knee Arthroplasty With Vitamin E Polyethylene

Knee Osteoarthritis Clinical Trial

Official title:

Total Knee Arthroplasty With Vitamin E Polyethylene

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05810285
• Other study ID #: VITALECOQ2020
• Status: Completed
• Start date: June 12, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2024
• Source: Permedica spa
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• GKS Prime Flex Mobile knee
Total knee arthroplasty with a cemented mobile bearing bicompartmental knee prosthesis

Locations

Country	Name	City	State
Italy	Ospedale Centro Ortopedico di Quadrante	Omegna	Verbania

Sponsors (1)

Lead Sponsor	Collaborator
Permedica spa

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Periprosthetic radiolucent line	Radiographic sign of bone remodelling around the implant	Minimum follow-up of 5 years
Secondary	Periprosthetic osteolysis	Radiographic sign of focal bone resorption around the implant	Minimum follow-up of 5 years