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Набор скоро начнётся NCT06907368

Analysis of the Functional Impact of Total Knee Arthroplasty Using Quantified Gait Analysis and Proprioceptive Evaluation

— Наблюдательное Total Knee Arthroplasty for 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: Quantitative Gait Analysis.
Кому может быть актуально
Состояния в реестре: Total Knee Arthroplasty for Gonarthrosis. Базовые параметры: от 18 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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Официальное название

Analysis of the Functional Impact of Total Knee Arthroplasty Using Quantified Gait Analysis and Proprioceptive Evaluation. Prospective, Single-center, Open-label Study, Cohort Follow-up.

Обзор

Total knee arthroplasty remains the gold standard in the management of disabling gonarthrosis. Improved functional results, increased availability of care and an ageing population have all contributed to the rise in total knee replacement surgery in Western countries. Surgical techniques have been steadily improving for several decades in terms of implant positioning and joint alignment. However, 10% of patients are dissatisfied with the clinical and functional results. The challenge is to understand why these patients remain dissatisfied despite these surgical advances. Our aim is to understand the functional impact of knee prosthesis through a quantified analysis of gait, the performance of certain tasks of daily living, and pre- and post-operative proprioceptive assessments. We will link these results with patient feedback to identify factors potentially responsible for poor postoperative outcomes.

Вмешательства

  • Другое Quantitative Gait Analysis
    The following explorations will be carried out pre-operatively (pre-OP), then post-operatively at 3 months (post-OP3) and 12 months (post-OP12) : * Quantified gait analysis (QGA) * Functional tests (mechanical analysis of everyday tasks): * SIT-TO-STAND test (test consisting of standing up and sitting down on a chair) * STEP INITIATION test (test consisting of walking up a step and then down) * Proprioceptive tests : * Joint Position Sense (JPS) (angle memorization and reproduction test

Первичные конечные точки

  • Post-operative functional recovery of patients who have undergone total knee arthroplasty for gonarthrosis by analyzing their locomotion ability [Срок оценки: Preoperatively (PreOP) and 12 months postoperatively (PostOP12)]
Вторичные конечные точки (9)
  • Functional recovery by analyzing changes in gait variability [Срок оценки: Preoperatively (PreOP) , 3 months postoperatively (PostOP3), 12 months postoperatively (PostOP3)]
  • Impact of total knee arthroplasty (TKA) on proprioception [Срок оценки: Preoperatively (PreOP) , 3 months postoperatively (PostOP3), 12 months postoperatively (PostOP3)]
  • Functional recovery after TKA by analyzing changes in daily living tasks by SIT TO STAND test [Срок оценки: Preoperatively (PreOP) , 3 months postoperatively (PostOP3), 12 months postoperatively (PostOP3)]
  • Functional recovery after TKA by analyzing changes in daily living tasks by STEP INITIATION test [Срок оценки: Preoperatively (PreOP) , 3 months postoperatively (PostOP3), 12 months postoperatively (PostOP3)]
  • Functional recovery after TKA by analyzing changes in daily living tasks by OBSTACLE CLEARANCE test [Срок оценки: Preoperatively (PreOP) , 3 months postoperatively (PostOP3), 12 months postoperatively (PostOP3)]
  • Evolution of Quality of Life [Срок оценки: Preoperatively (PreOP) , 3 months postoperatively (PostOP3), 12 months postoperatively (PostOP3)]
  • Evolution of the patient's functional results assessed by the KSS questionnaire [Срок оценки: Preoperatively (PreOP) , 3 months postoperatively (PostOP3), 12 months postoperatively (PostOP3)]
  • Evolution of the patient's functional results assessed by the SKV questionnaire [Срок оценки: Preoperatively (PreOP) , 3 months postoperatively (PostOP3), 12 months postoperatively (PostOP3)]
  • Evolution of the patient's functional results assessed by the KOOS questionnaire [Срок оценки: Preoperatively (PreOP) , 3 months postoperatively (PostOP3), 12 months postoperatively (PostOP3)]

Критерии участия

Критерии включения

  • Adult patient
  • Gonarthrosis on imaging with indication for total knee arthroplasty (TKA)
  • Isolated gonarthrosis

Критерии исключения

  • Patient objecting to study participation
  • Patient with an associated pathology causing balance and/or proprioceptive disorders (Parkinson's, stroke sequelae, etc.).
  • Patients with a history of cognitive disorders, either confirmed or currently being assessed.
  • IADL score below 3, indicating major dependence in daily life.
  • Patients unable to walk without technical aids for 6 months.
  • Patients unable to get up from a chair without armrests
  • Parker score below 6
  • Protected persons covered by articles L1121-5 to L1121-8 of the French Public Health Code

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 1 центр
  • Grenoble University Hospital — Grenoble

Идентификаторы

NCT: NCT06907368 · 38RC24.0425

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗