Total Knee Arthroplasty With Vitamin E Polyethylene

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Device: GKS Prime Flex Mobile knee

• Registration Number: NCT05810285
• Lead Sponsor: Permedica spa

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-12
• Study First Submitted: 2023-03-28
• Study First Submitted QC: 2023-04-11
• Study First Posted: 2023-04-12
• Primary Completion: 2023-06-27
• Study Completion: 2023-06-27
• Results First Submitted: 2024-07-25
• Status Verified: 2024-10
• Results First Submitted QC: 2024-10-18
• Results First Posted: 2024-12-06
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2025-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 186

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
VITAMIN E	GKS Prime Flex Mobile knee	Patients who received cemented total knee arthroplasty with vitamin E blended polyethylene mobile bearing
POLYETHYLENE	GKS Prime Flex Mobile knee	Patients who received cemented total knee arthroplasty with conventional polyethylene mobile bearing

Primary Outcome Measures

Name	Time	Method
Implant Survival for Aseptic Loosening	10-year follow-up	Kaplan-Meier cumulative survival with revision due to aseptic loosening as the end-point

Secondary Outcome Measures

Name	Time	Method
Implant Survival for Any Reason	10-year follow-up	Kaplan-Meier cumulative survival with revision due to any reason as the end-point
Forgotten Joint Score (FJS-12)	At mean follow-up of 8.5 years and 8.3 years for Vitamin E and Polyethylene, respectively	Patient related outcome measurement scored from 0 to 100 (higher scores mean better outcomes)
American Knee Society Score (KSS)	At mean follow-up of 8.5 years and 8.3 years for Vitamin E and Polyethylene, respectively	Clinical and Functional scores of the knee. Both scores are scored from 0 to 100 (higher scores mean better outcomes)
Periprosthetic Radiolucent Line	At mean follow-up of 8.5 years and 8.3 years for Vitamin E and Polyethylene, respectively	Radiographic sign of bone remodelling around the implant
Periprosthetic Osteolysis	At mean follow-up of 8.5 years and 8.3 years for Vitamin E and Polyethylene, respectively	Radiographic sign of focal bone resorption around the implant

Trial Locations

Locations (1)

Ospedale Centro Ortopedico di Quadrante; 🇮🇹 Omegna, Verbania, Italy