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Набор скоро начнётся NCT07551089

Kinematic vs Mechanical Alignment in High Tibial Osteotomy

Без фазы С лечением Osteo Arthritis of the Knee Genu Varum

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: high tibial osteotomy.
Кому может быть актуально
Состояния в реестре: Osteo Arthritis of the Knee, Genu Varum. Базовые параметры: Без ограничений · 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

The Short Term Outcome of Kinematic Versus Mechanichal Alignment After High Tibial Osteotomy for Varus Osteoarthritic Knee : A Prospective Randomized Controlled Trial

Обзор

To compare between kinematic and mechanichal alignment after High Tibial Osteotomy (clinically and radiologically)

Подробное описание

High tibial osteotomy (HTO) is a well-established joint-preserving procedure for younger and active patients with medial compartment osteoarthritis associated with varus malalignment. By laterally shifting the mechanical axis of the lower limb, HTO unloads the diseased medial compartment, alleviates pain, and delays the need for knee arthroplasty.

Traditionally, HTO planning has relied on a Mechanical alignment strategy, aiming to shift the weight-bearing line toward the lateral compartment. Fujisawa et al. described targeting a point located at approximately 62-65% of the tibial plateau width, which has been shown to optimize medial compartment unloading and improve long-term survivorship following HTO.

However, mechanical alignment applies a uniform correction target without accounting for individual anatomical variability. This is commonly achieved by correcting varus alignment to a slight valgus position (approximately 3-5°) through increasing the medial proximal tibial angle (MPTA). Such standardized correction may result in overcorrection, increased joint-line obliquity, altered soft-tissue balance, and excessive loading of the lateral compartment. These biomechanical changes may accelerate lateral cartilage degeneration and contribute to postoperative complications, potentially compromising long-term outcomes.

In contrast, Kinematic alignment (KA) is based on restoring the patient's native anatomical alignment and physiological joint-line orientation, rather than forcing all patients toward a fixed valgus target. By correcting only the pathological varus deformity and restoring the MPTA toward physiological values without overcorrection, kinematic alignment aims to preserve normal knee biomechanics and balanced soft-tissue tension.

Accordingly, the present study aims to make HTO not a temporary relief evaluate whether a kinematic alignment strategy in HTO can achieve comparable or superior clinical and radiological outcomes compared with mechanical alignment, while potentially reducing complications and delaying the need for total knee replacement.

Вмешательства

  • Процедура high tibial osteotomy
    High tibial osteotomy (HTO) is a well-established joint-preserving procedure for younger and active patients with medial compartment osteoarthritis associated with varus malalignment. By laterally shifting the mechanical axis of the lower limb, HTO unloads the diseased medial compartment, alleviates pain, and delays the need for knee arthroplasty

Первичные конечные точки

  • oxford knee score [Срок оценки: 12 months]
Вторичные конечные точки (2)
  • Knee Injury and Osteoarthritis Outcome Score (KOOS) [Срок оценки: 12 months]
  • University of California Los Angeles (UCLA) Activity Score [Срок оценки: 12 months]

Критерии участия

Критерии включения

  • Clinical: 1. Age : Adult with symptomatic osteoarthritic varus knee 2-Medial knee pain with functional limitation ≥6 months despite optimized non-operative care.

Radiological: 1- Medial compartment OA in Xray AP-Lateral view 2-Degree of varus ≥3 and ≤15 degree in long film(full-length, standing hip-to-ankle radiographs) 3-•Varus knee (mpta ≤85 degree and ldfa ≤93 and jlca ≤5)

Physical : 1-Range of motion: Flexion ≥110°, flexion contracture ≤10°, extension lag ≤5°.

2-Gait testing: Able to walk unaided (or with standard aid) for instrumented gait analysis.

Критерии исключения

  • 1- Predominantly lateral compartment OA 2- severe patellofemoral arthritis 3- Prior high tibial osteotomy, knee arthroplasty, or complex fracture around the knee 4-Inflammatory arthropathies (eg, rheumatoid arthritis) 5- end stage medial compartment osteoarthritis with bone erosions 6-chondrocalcinosis

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
Открытое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07551089 · High Tibial Osteotomy

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗