- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT03072459
A Retrospective Study of the Navio Robotic-assisted Surgical System (NAVIO)
A Retrospective Study of the Navio™ Robotic-assisted Surgical System
Обзор исследования
Статус
Условия
Подробное описание
Тип исследования
Регистрация (Действительный)
Контакты и местонахождение
Места учебы
-
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Arizona
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Phoenix, Arizona, Соединенные Штаты, 85016
- Hedley Orthopedics
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California
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Santa Barbara, California, Соединенные Штаты, 93105
- Santa Barbara Cottage Hospital
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Michigan
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Battle Creek, Michigan, Соединенные Штаты, 49015
- Bronson Orthopedic Specialists
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Ohio
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New Albany, Ohio, Соединенные Штаты, 43054
- OrthoNeuro New Albany
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Pennsylvania
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Philadelphia, Pennsylvania, Соединенные Штаты, 19107
- Rothman Institute
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
Описание
Inclusion Criteria:
- Male or female subjects ≥ 18 years old (at the time of surgery) who have undergone Navio System-assisted UKR at least 2 years prior to enrollment. This includes UKR procedures with all Unicondylar Knee cemented implant designs.
- Subject had a primary diagnosis of unicompartmental, non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis, required correction of functional deformity, or required treatment of fractures that were unmanageable using other techniques.
Exclusion Criteria:
- Subject received the Navio System-assisted UKR on the index joint as a revision for a previously failed UKR.
- Subject, in the opinion of the Investigator, had advanced osteoarthritis or joint disease at the time of surgery and was better suited for Total Knee Arthroplasty (TKA).
- Subject, in the opinion of the Investigator, had a neuromuscular disorder that prohibited control of the index joint.
- Subject, in the opinion of the Investigator, was morbidly obese.
- Subject, in the opinion of the Investigator, was contraindicated for UKR.
- Subject (prospective subjects only), in the opinion of the Investigator, has an emotional or neurological condition including mental illness, mental retardation, drug or alcohol abuse.
- Subject (prospective subjects only) is a prisoner.
Учебный план
Как устроено исследование?
Детали дизайна
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Evaluate the Navio™ System for Revisions at 2+ Years Post-surgical Implantation Survivorship
Временное ограничение: Preoperative (Baseline) and 24, 48, 72, 96, and 120 weeks postoperatively
|
Analysis of the absence of device revision (overall survivorship) outcomes assessed from Baseline through 120 weeks post-surgical implantation.
|
Preoperative (Baseline) and 24, 48, 72, 96, and 120 weeks postoperatively
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Evaluation of Efficacy Based on Knee Society Score (KSS) Assessments
Временное ограничение: Preoperative (Baseline) and 6, 12, 18, 24, 30, and 36 months postoperatively
|
Analysis of KSS from preoperatively (Baseline) up to 36 months postoperatively in 6-months increments to evaluate objective observation, patient satisfaction, and function. Objective knee indicators: Range 0-100 points; Patient Satisfaction: Range 0-40 points; and Functional Activities: Range 0-100 points. Higher scores indicated a better outcome. |
Preoperative (Baseline) and 6, 12, 18, 24, 30, and 36 months postoperatively
|
Evaluation of Efficacy Based on Veterans RAND 12 (VR-12) Assessments
Временное ограничение: Preoperative (Baseline) and 6, 12, 18, 24, 30, and 36 months postoperatively
|
Analysis of VR-12 scores preoperatively (Baseline) through 36 months postoperatively in 6 months increments. These scores encompass the individual domains of physical component score (PCS), mental component score (MCS) as well as the sub-domain scores within the PCS (physical functioning, role physical, bodily pain, and general health) and those within the MCS (vitality, social functioning, role emotional, and mental health). Domain Scores: Physical Component Score (PCS): Range 1 to 20 Mental Component Score (MCS): Range 1 to 25 Sub-domain Scores: Physical Functioning: Range 1 to 6 Role Physical: Range 1 to 4 Bodily Pain: Range 1 to 6 General Health: Range 1 to 6 Vitality: Range 1 to 6 Social Functioning: Range 1 to 6 Role Emotional: Range 1 to 4 Mental Health: Range 1 to 10 Transformation of raw scale scores (range 0-100) = {(actual raw score - lowest possible raw score)/possible raw score range} x100 A higher score indicates a better outcome. |
Preoperative (Baseline) and 6, 12, 18, 24, 30, and 36 months postoperatively
|
Preoperative Evaluation of Efficacy Based on Radiographic Findings
Временное ограничение: Preoperative (Baseline)
|
Changes in radiographic findings (anterior-posterior [AP] and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.
|
Preoperative (Baseline)
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Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings
Временное ограничение: 6 months postoperatively
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Changes in radiographic findings (AP and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.
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6 months postoperatively
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Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings
Временное ограничение: 12 months postoperatively
|
Changes in radiographic findings (AP and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.
|
12 months postoperatively
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Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings
Временное ограничение: 18 months postoperatively
|
Changes in radiographic findings (AP and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.
|
18 months postoperatively
|
Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings
Временное ограничение: 24 months postoperatively
|
Changes in radiographic findings (AP and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.
|
24 months postoperatively
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Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings
Временное ограничение: 30 months postoperatively
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Changes in radiographic findings (AP and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.
|
30 months postoperatively
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Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings
Временное ограничение: 36 months postoperatively
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Changes in radiographic findings (AP and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.
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36 months postoperatively
|
Соавторы и исследователи
Спонсор
Следователи
- Директор по исследованиям: Beate Hanson, MD, PhD, Smith & Nephew, Inc.
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Другие идентификационные номера исследования
- 16-NPFS-11
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .