Идёт набор NCT04230616

Efficacy and Safety of NAVIO

Без фазы С лечением Osteoarthritis, Knee

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, CT scan.
Кому может быть актуально: Состояния в реестре: Osteoarthritis, Knee. 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: Бельгия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Comparison of Clinical Outcome and Alignment of NAVIO Total Knee Arthroplasty and Conventional Total Knee Arthroplasty A Prospective, Randomized, Controlled, Single Blind Study

Обзор

The goal of the study is to compare the efficacy, safety and costs of the NAVIO™ system with the conventional intramedullary alignment guide for total knee replacement in a clinical setting. The hypothesis is that total knee arthroplasty (TKA) with the use of NAVIO™ is at least as efficient and safe as TKA with the use of conventional intramedullary alignment guiding.

Вмешательства

Процедура total knee arthroplasty
total knee arthroplasty
Лучевая терапия CT scan
The first 52 participants will recieve a pre- and postoperative CT scan of the hip, knee and ankle.

Первичные конечные точки

Difference in planned and achieved alignment in degrees based on CT scan pre- and postoperatively (first 52 participants) [Срок оценки: within 6 weeks pre-surgery and 6 weeks post-surgery]
Difference in planned and achieved mechanical axis in degrees based on CT scan pre- and postoperatively (first 52 participants) [Срок оценки: within 6 weeks pre-surgery and 6 weeks post-surgery]
Difference in percentage of outliers of alignment on CT scan pre- and postoperatively (first 52 participants) [Срок оценки: within 6 weeks pre-surgery and 6 weeks post-surgery]
Difference in percentage of outliers of mechanical axis based on CT scan pre- and postoperatively (first 52 participants) [Срок оценки: within 6 weeks pre-surgery and 6 weeks post-surgery]
Mean change in the visual analogue scale scores [Срок оценки: within 6 weeks preoperative, 24 hours post-surgery, day of discharge, 6 weeks post-surgery, 3 months post-surgery, 1 year post-surgery, 2 years post-surgery, 5 years post-surgery, 10 years post-surgery]
Mean change in the American Knee Society Score [Срок оценки: within 6 weeks preoperative, 3 months post-surgery, 1 year post-surgery, 2 years post-surgery, 5 years post-surgery, 10 years post-surgery]
Mean change in the Oxford Knee Score [Срок оценки: within 6 weeks preoperative, 3 months post-surgery, 1 year post-surgery, 2 years post-surgery, 5 years post-surgery, 10 years post-surgery]
Mean change in the Lower Extremities Activity scale [Срок оценки: within 6 weeks preoperative, day of discharge, 6 weeks post-surgery, 3 months post-surgery, 1 year post-surgery, 2 years post-surgery, 5 years post-surgery, 10 years post-surgery]
Mean change in the The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [Срок оценки: within 6 weeks preoperative, 3 months post-surgery, 1 year post-surgery, 2 years post-surgery, 5 years post-surgery, 10 years post-surgery]
Difference in mechanical axis of the prosthesis between the two study arms based on Long-leg X-rays [Срок оценки: within 6 weeks preoperative, 6 weeks post-surgery, 1 year post-surgery, 5 years post-surgery, 10 years post-surgery]

Критерии участия

Критерии включения

Painful and disabled knee joint resulting from osteoarthritis where one or more compartments are involved, as assessed by X-ray
High need to obtain pain relief and improve function
Above 18 years old
Able and willing to follow instructions
Informed consent