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Идёт набор NCT06258369

Gait Initiation and Transition From Double to Single Support in Patients With Unilateral Primary Coxarthrosis

Без фазы С лечением Primary; Coxarthrosis

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: Patients with primary coxarthrosis (any stage)., Patients with primary coxarthrosis (any stage) and operated with Total Hip Prosthesis (THP)., Patients with primary coxarthrosis (any stage) and operated with RTH (Hip resurfacing)..
Кому может быть актуально
Состояния в реестре: Primary; Coxarthrosis. 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

Gait Initiation and Transition From Double to Single Support in Patients With Unilateral Primary Coxarthrosis Who Have Not Undergone Surgery and Before/After Arthroplasty

Обзор

The study consists to evaluate the impact of prosthetic surgery (PTH and RTH) on kinematic and dynamic parameters (joint torques) of the lower limbs during gait initiation in patients with primary coxarthrosis. Patients included in the study will undergo a three-dimensional gait analysis. Dynamic gait analysis is multidimensional, measuring kinematic parameters (joint amplitudes: ankles, knees, hips, etc.) and dynamic parameters (assessment of joint torque from ankle, knee, hip to lower limb during gait initiation).

Вмешательства

  • Другое Patients with primary coxarthrosis (any stage).
    Patients who do not undergo surgery will be called specifically for the study to attend a consultation dedicated to gait assessment.
  • Другое Patients with primary coxarthrosis (any stage) and operated with Total Hip Prosthesis (THP).
    Patients scheduled for THP (Total Hip Prosthesis) will be seen at the consultation the day before surgery, in the same hospital as the THP, or at an existing dedicated consultation scheduled for all THP patients. During these scheduled visits, they will be received in the gait analysis laboratory for a gait assessment (V1). Patients will be seen again at 6 months post-operatively for a second gait assessment (V2).
  • Другое Patients with primary coxarthrosis (any stage) and operated with RTH (Hip resurfacing).
    Patients scheduled for RTH (Hip Resurfacing) will be seen at the consultation the day before surgery, in the same hospital as the RTH, or at an existing dedicated consultation scheduled for all RTH patients. During these scheduled visits, they will be received in the gait analysis laboratory for a gait assessment (V1). Patients will be seen again at 6 months post-operatively for a second gait assessment (V2).

Первичные конечные точки

  • Amplitude degree of lower limbs articulations [Срок оценки: 6 months]
  • Dynamics of limbs joint torques during walking initiation measured in Nm/kg [Срок оценки: 6 months]
Вторичные конечные точки (12)
  • Step length during gait initiation [Срок оценки: 6 months]
  • Step width during gait initiation [Срок оценки: 6 months]
  • Duration of first step during gait initiation [Срок оценки: 6 months]
  • Duration of anticipatory postural adjustment phase during gait initiation [Срок оценки: 6 months]
  • Duration of execution phase during gait initiation [Срок оценки: 6 months]
  • Measurement of the trajectory during gait initiation [Срок оценки: 6 months]
  • Measurement of the speed during gait initiation [Срок оценки: 6 months]
  • Measurement of the amplitude of retreat of the center of pressure during gait initiation [Срок оценки: 6 months]
  • Severity of coxarthrosis according to the Tönnis classification [Срок оценки: 6 Months]
  • HHS (Harris Hip Score) [Срок оценки: 6 months]
  • PMA (Postel Merle d'Aubigné) score [Срок оценки: 6 months]
  • Devane score [Срок оценки: 6 months]

Критерии участия

Критерии включения

  • Men or women aged 18 and over
  • With primary coxarthrosis (any stage)
  • Consulting in the orthopedic departments of participating centers in anticipation of hip surgery (PTH/RTH), or for advice only.
  • Written consent signed by the patient
  • Affiliation with a social security scheme

Критерии исключения

  • Disabling orthopaedic conditions:

Symptomatic contralateral hip/knee disease Symptomatic gonarthrosis or homolateral total knee prosthesis History of surgery on the affected hip History of fracture of the lower limb in the past year History of lower limb sprain in the last 3 months Neurological or degenerative disease

  • Pregnant or breast-feeding
  • Adults under guardianship, curatorship or safeguard of justice
  • Cognitive impairment making it impossible to understand the protocol
  • Approach other than Moore posterolateral (for PTH and RTH groups)

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Другое

Центры проведения

Франция · 2 центра
  • CHU de Lille — Lille
  • Hôpital Saint-Philibert (GHICL) — Lomme

Идентификаторы

NCT: NCT06258369 · RC-P00122

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗