Clinical trial NCT06676189: Comparison of Pivotal Medial Polyethylene Versus Ultra-congruent in Total Knee Arthroplasty
Official title: Comparison of Pivotal Medial Polyethylene Versus Ultra-congruent in Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Total Knee Replacement
Primary Knee Replacement
Gonarthrosis
Keywords: prospective
randomized study
parallel groups
forgotten joint score
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2024-11-06
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion criteria :

* Subjects 18 to 90 years of age, eligible for a primary total knee replacement for gonarthrosis
* Competent subjects able to give informed consent to participate in the research
* Affiliation to the social security system

Exclusion criteria :

* Infection history of the knee to be replaced
* Deformity greater than 15 degrees
* Any surgical and/or anesthetic contraindication, or any condition deemed by the investigator to be incompatible with the research.
* Any contraindication mentioned in the instructions for use of the medical device
* Pregnant or breastfeeding women
* Recent infection history of the surgical site
* Adults who are subject to a legal protection measure or who are unable to express their constent (Article L1121-8 of the French Public Health Code) and subjects under judicial protection (article L. 1122-2 FPHC)
* Subjects who refuse to participate

Primary outcomes:
measure: evaluation of the forgotten joint score (FJS12)
timeFrame: Day 45
measure: evaluation of the forgotten joint score (FJS12)
timeFrame: Month 12
Secondary outcomes:
measure: knee joint mobility
timeFrame: Day -1
measure: knee joint mobility
timeFrame: Day 45
measure: knee joint mobility
timeFrame: month 12
measure: pain assessment
timeFrame: Day -1
measure: pain assessment
timeFrame: day 45
measure: pain assessment
timeFrame: month 12
measure: the Knee Society Score (KSS)
timeFrame: Day -1
measure: the Knee Society Score (KSS)
timeFrame: Day 45
measure: the Knee Society Score (KSS)
timeFrame: month 12
measure: Knee injury and Osteoarthritis Outcome Score Physical Function Short form (KOOS-PS).
timeFrame: day -1
measure: Knee injury and Osteoarthritis Outcome Score Physical Function Short form (KOOS-PS).
timeFrame: Day 45
measure: Knee injury and Osteoarthritis Outcome Score Physical Function Short form (KOOS-PS).
timeFrame: Month 12
measure: radiographic alignment
timeFrame: month 12
measure: radiological complications
timeFrame: Day -1
measure: radiological complications
timeFrame: Day 45
measure: radiological complications
timeFrame: Month 12
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Stéphane DESCAMPS
role: PRINCIPAL_INVESTIGATOR
References: