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NCT Number: NCT06676189

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

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

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Clermont-Ferrand

Clermont-Ferrand, France

Location status: Recruiting

Location contact

Lise Laclautre

CONTACT

Stéphane DESCAMPS

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

total knee arthroplasty with medial pivot polyethylene

Device

total knee arthroplasty with medial pivot polyethylene

total knee arthroplasty with ultra-congruent polyethylene

Device

total knee arthroplasty with ultra-congruent polyethylene

Primary outcomes

  1. evaluation of the forgotten joint score (FJS12)

    Time frame: Day 45

    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

  2. evaluation of the forgotten joint score (FJS12)

    Time frame: Month 12

    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

Secondary outcomes

  1. knee joint mobility

    Time frame: Day -1

    Measurement of mobility in degrees (scale from 0 to 10)

  2. knee joint mobility

    Time frame: Day 45

    Measurement of mobility in degrees (scale from 0 to 10)

  3. knee joint mobility

    Time frame: month 12

    Measurement of mobility in degrees (scale from 0 to 10)

  4. pain assessment

    Time frame: Day -1

    assessment with a numeric pain rating scale ranging from 0 (none) to 10 (severe pain)

  5. pain assessment

    Time frame: day 45

    assessment with a numeric pain rating scale ranging from 0 (none) to 10 (severe pain)

  6. pain assessment

    Time frame: month 12

    assessment with a numeric pain rating scale ranging from 0 (none) to 10 (severe pain)

  7. the Knee Society Score (KSS)

    Time frame: Day -1

    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)

  8. the Knee Society Score (KSS)

    Time frame: Day 45

    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)

  9. the Knee Society Score (KSS)

    Time frame: month 12

    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)

  10. Knee injury and Osteoarthritis Outcome Score Physical Function Short form (KOOS-PS).

    Time frame: day -1

    the KOOS-PS (free of charge) is used to assess the postoperative quality of life related to knee joint pathologies.

  11. Knee injury and Osteoarthritis Outcome Score Physical Function Short form (KOOS-PS).

    Time frame: Day 45

    the KOOS-PS (free of charge) is used to assess the postoperative quality of life related to knee joint pathologies.

  12. Knee injury and Osteoarthritis Outcome Score Physical Function Short form (KOOS-PS).

    Time frame: Month 12

    the KOOS-PS (free of charge) is used to assess the postoperative quality of life related to knee joint pathologies.

  13. radiographic alignment

    Time frame: month 12

    measurement of the anteroposterior radiographic alignment at 1 year post-operative using the Hip-knee-ankle (HKA) angle

  14. radiological complications

    Time frame: Day -1

    Peri- and post-operative complications using standard radiographic analysis (static radiographs of the lower limbs, anteroposterior and lateral knee radiographs, patellofemoral view at 45°)

  15. radiological complications

    Time frame: Day 45

    Peri- and post-operative complications using standard radiographic analysis (static radiographs of the lower limbs, anteroposterior and lateral knee radiographs, patellofemoral view at 45°)

  16. radiological complications

    Time frame: Month 12

    Peri- and post-operative complications using standard radiographic analysis (static radiographs of the lower limbs, anteroposterior and lateral knee radiographs, patellofemoral view at 45°)

Study contacts

Contact information is provided by the study sponsor or research team.

Lise Laclautre

CONTACT

[email protected]

334.73.754.963

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Acronym: MEPCAT

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Nov 6, 2024
Registry last updated
Jan 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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