NCT06676189

Comparison of Pivotal Medial Polyethylene Versus Ultra-congruent in Total Knee Arthroplasty

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: University Hospital, Clermont-Ferrand · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to compare the forgotten joint score for the medial pivot polyethylene and ultra-congruent polyethylene which are used in total prosthetic replacement of the knee

Detailed description

Total knee arthroplasty is usually effective at improving the quality of life of patients suffering from arthritis. Over the years, patient expectations about the quality of life post-implantation continue to rise. It is therefore essential to improve continuously surgical techniques and implants to fulfill patient expectations in terms of pain and movements. The prosthetic device is composed of a metallic femoral unit, which imitates the articular surface of the femur, and a metallic tibial baseplate covered with a polyethylene (a highly resistant polymer) insert which articulates between the femur and the tibia. This insert can take several forms such as medial pivot or ultra-congruent. This polymer provides an interface between the two metallic units forming the prothetic device. It has two roles: it provides a lasting contact surface and it offers stability to the knee in substitution of the ligaments. In order to achieve this double function, a polyethylene system, called " medial pivot " was conceived. This system mimics as close as possible the anatomical knee kinematics with a rotational movement that the " ball in socket " tries to reproduce by the mediatisation of the pivot point during knee flexion. Currently, there are no randomized study which were conducted comparing these two types of polyethylene. Total knee arthroplasty is usually effective at improving the quality of life of patients suffering from arthritis. Over the years, patient expectations about the quality of life post-implantation continue to rise. It is therefore essential to improve continuously surgical techniques and implants to fulfill patient expectations in terms of pain and movements. The prosthetic device is composed of a metallic femoral unit, which imitates the articular surface of the femur, and a metallic tibial baseplate covered with a polyethylene (a highly resistant polymer) insert which articulates between the femur and the tibia. This insert can take several forms such as medial pivot or ultra-congruent. This polymer provides an interface between the two metallic units forming the prothetic device. It has two roles: it provides a lasting contact surface and it offers stability to the knee in substitution of the ligaments. In order to achieve this double function, a polyethylene system, called " medial pivot " was conceived. This system mimics as close as possible the anatomical knee kinematics with a rotational movement that the " ball in socket " tries to reproduce by the mediatisation of the pivot point during knee flexion. Currently, there are no randomized study which were conducted comparing these two types of polyethylene.

Conditions

• Total Knee Replacement
• Primary Knee Replacement
• Gonarthrosis

Interventions

Type	Name	Description
DEVICE	total knee arthroplasty with medial pivot polyethylene	total knee arthroplasty with medial pivot polyethylene
DEVICE	total knee arthroplasty with ultra-congruent polyethylene	total knee arthroplasty with ultra-congruent polyethylene

Timeline

• Start date: 2024-06-04
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2024-11-06
• Last updated: 2025-01-17

Locations

1 site across 1 country: France