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Идёт набор NCT06676189

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

Без фазы С лечением Total Knee Replacement Primary Knee Replacement Gonarthrosis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: total knee arthroplasty with medial pivot polyethylene, total knee arthroplasty with ultra-congruent polyethylene.
Кому может быть актуально
Состояния в реестре: Total Knee Replacement, Primary Knee Replacement, Gonarthrosis. Базовые параметры: 18 лет — 90 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
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Обзор

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

Подробное описание

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.

Вмешательства

  • Устройство total knee arthroplasty with medial pivot polyethylene
    total knee arthroplasty with medial pivot polyethylene
  • Устройство total knee arthroplasty with ultra-congruent polyethylene
    total knee arthroplasty with ultra-congruent polyethylene

Первичные конечные точки

  • evaluation of the forgotten joint score (FJS12) [Срок оценки: Day 45]
  • evaluation of the forgotten joint score (FJS12) [Срок оценки: Month 12]
Вторичные конечные точки (12)
  • knee joint mobility [Срок оценки: Day -1]
  • knee joint mobility [Срок оценки: Day 45]
  • knee joint mobility [Срок оценки: month 12]
  • pain assessment [Срок оценки: Day -1]
  • pain assessment [Срок оценки: day 45]
  • pain assessment [Срок оценки: month 12]
  • the Knee Society Score (KSS) [Срок оценки: Day -1]
  • the Knee Society Score (KSS) [Срок оценки: Day 45]
  • the Knee Society Score (KSS) [Срок оценки: month 12]
  • Knee injury and Osteoarthritis Outcome Score Physical Function Short form (KOOS-PS). [Срок оценки: day -1]
  • Knee injury and Osteoarthritis Outcome Score Physical Function Short form (KOOS-PS). [Срок оценки: Day 45]
  • Knee injury and Osteoarthritis Outcome Score Physical Function Short form (KOOS-PS). [Срок оценки: Month 12]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Франция · 1 центр
  • CHU de Clermont-Ferrand — Clermont-Ferrand

Идентификаторы

NCT: NCT06676189 · RBHP 2023 DESCAMPS (MEPCAT) · 2023-A01565-40

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗