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

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

Study Overview

• Status: Recruiting
• Conditions: Gonarthrosis; Total Knee Replacement; Primary Knee Replacement
• Intervention / Treatment: Device: total knee arthroplasty with medial pivot polyethylene; Device: total knee arthroplasty with ultra-congruent polyethylene

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.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lise Laclautre; Phone Number: 334.73.754.963; Email: promo_interne_drci@chu-clermontferrand.fr

Study Locations

• France
  • Clermont-Ferrand, France
    • Recruiting
    • CHU de Clermont-Ferrand
    • Principal Investigator: Stéphane DESCAMPS
    • Contact: Lise LACLAUTRE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: medial pivot polyethylene; Total knee replacement with medial pivot polyethylene	Device: total knee arthroplasty with medial pivot polyethylene; total knee arthroplasty with medial pivot polyethylene
Active Comparator: ultra-congruent polyethylene; Total knee replacement with ultra-congruent polyethylene	Device: total knee arthroplasty with ultra-congruent polyethylene; total knee arthroplasty with ultra-congruent polyethylene

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
evaluation of the forgotten joint score (FJS12)	Forgotten knee score at 6 weeks (FJS-12, evaluated out of 100), which allows the analysis of quality of life specifically in relation to knee pathologies	Day 45
evaluation of the forgotten joint score (FJS12)	Forgotten knee score at 6 weeks (FJS-12, evaluated out of 100), which allows the analysis of quality of life specifically in relation to knee pathologies	Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
knee joint mobility	Measurement of mobility in degrees (scale from 0 to 10)	Day -1
knee joint mobility	Measurement of mobility in degrees (scale from 0 to 10)	Day 45
knee joint mobility	Measurement of mobility in degrees (scale from 0 to 10)	month 12
pain assessment	assessment with a numeric pain rating scale ranging from 0 (none) to 10 (severe pain)	Day -1
pain assessment	assessment with a numeric pain rating scale ranging from 0 (none) to 10 (severe pain)	day 45
pain assessment	assessment with a numeric pain rating scale ranging from 0 (none) to 10 (severe pain)	month 12
the Knee Society Score (KSS)	the KSS (free of charge) scoring system is divided into 2 subcategories: a clinical score (maximum of 100 points) and a functional score (maximum of 100 points)	Day -1
the Knee Society Score (KSS)	the KSS (free of charge) scoring system is divided into 2 subcategories: a clinical score (maximum of 100 points) and a functional score (maximum of 100 points)	Day 45
the Knee Society Score (KSS)	the KSS (free of charge) scoring system is divided into 2 subcategories: a clinical score (maximum of 100 points) and a functional score (maximum of 100 points)	month 12
Knee injury and Osteoarthritis Outcome Score Physical Function Short form (KOOS-PS).	the KOOS-PS (free of charge) is used to assess the postoperative quality of life related to knee joint pathologies.	day -1
Knee injury and Osteoarthritis Outcome Score Physical Function Short form (KOOS-PS).	the KOOS-PS (free of charge) is used to assess the postoperative quality of life related to knee joint pathologies.	Day 45
Knee injury and Osteoarthritis Outcome Score Physical Function Short form (KOOS-PS).	the KOOS-PS (free of charge) is used to assess the postoperative quality of life related to knee joint pathologies.	Month 12
radiographic alignment	measurement of the anteroposterior radiographic alignment at 1 year post-operative using the Hip-knee-ankle (HKA) angle	month 12
radiological complications	Peri- and post-operative complications using standard radiographic analysis (static radiographs of the lower limbs, anteroposterior and lateral knee radiographs, patellofemoral view at 45°)	Day -1
radiological complications	Peri- and post-operative complications using standard radiographic analysis (static radiographs of the lower limbs, anteroposterior and lateral knee radiographs, patellofemoral view at 45°)	Day 45
radiological complications	Peri- and post-operative complications using standard radiographic analysis (static radiographs of the lower limbs, anteroposterior and lateral knee radiographs, patellofemoral view at 45°)	Month 12

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Stéphane DESCAMPS, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: October 24, 2024
• First Submitted That Met QC Criteria: November 4, 2024
• First Posted (Actual): November 6, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 16, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: prospective; randomized study; parallel groups; forgotten joint score
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: RBHP 2023 DESCAMPS (MEPCAT); 2023-A01565-40 (Other Identifier: 2023-A01565-40)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No