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Total Knee Arthroplasty: Functional and Clinical Outcomes

28 апреля 2017 г. обновлено: Duke University

Clinical and Functional Outcomes Following Total Knee Replacement Using Two Different Implants

The purpose of this study is to assess the differences in functional and patient reported outcomes between total knee replacement (TKA) implants. In addition, this work will examine the correlation between functional assessments and patient reported outcomes following surgery. All subjects will complete assessments preoperatively, 4-6 weeks following TKA and then one year following TKA. Subjects will complete a series of patient reported outcomes as well as a series of functional outcomes at each of the time points of interest. The analysis will include a repeated measures design to determine differences between groups across time as well as correlations between the functional and patient reported outcomes. This work will hopefully determine the importance of using objective functional outcomes following TKA as well as determining the need for patient assessments out to one year following surgery.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Подробное описание

The number differences in subjects analyzed from baseline to 6 weeks to 52 weeks are due to the fact that we did not use the 6 week time point in the final analysis based on the clinical decision that 6 weeks was too early in recovery to provide accurate information for clinical decision making. Therefore the patients used in the final analysis were those subjects who were able to and completed the assessment at pre-op and 1 year post-op which is how we get to the 20 subjects per group.

Тип исследования

Интервенционный

Регистрация (Действительный)

60

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 18 лет до 85 лет (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

Inclusion Criteria:

  1. Patients requiring primary total knee replacement
  2. Patients willing and able to comply with the follow-up visits and evaluations
  3. Patients willing to sign informed consent approved by the Institutional Review Board

Exclusion Criteria:

  1. Patients with inflammatory arthritis
  2. Patients with diabetic neuropathy
  3. Patients unable to ambulate without the use of an assistive device prior to surgery
  4. Patients unable to stand in single limb stance on each foot prior to surgery.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Поддерживающая терапия
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Активный компаратор: Stryker
Subjects will be receiving the Stryker Triathlon total knee replacement
Устройство: Stryker
Активный компаратор: Zimmer
Subjects will be receiving a Zimmer NexGen total knee replacement
Устройство: Zimmer

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Change in Lower Quarter Y-Balance Test (YBT-LQ) (Dynamic Balance) From Baseline to 6 Weeks Following Total Knee Replacement
Временное ограничение: Baseline (Pre-Operative) to 6 weeks following total knee replacement
The lower quarter y-balance test (YBT-LQ) is a test of dynamic balance in unilateral stance that has been deemed to be reliable and valid. The YBT-LQ consists of each patient standing on one leg and reaching as far as they can with their non-stance leg in the anterior, posteromedial and posterolateral direction while standing on the other foot on a centralized stance platform. The composite score is calculated as the sum of the three reach directions divided by 3 time the limb length and will be reported as a percentage of limb length.
Baseline (Pre-Operative) to 6 weeks following total knee replacement
Change in Lower Quarter Y-Balance Test (YBT-LQ) (Dynamic Balance) From Baseline to 52 Weeks Following Total Knee Replacement
Временное ограничение: Baseline (Pre-Operative) to 52 weeks following total knee replacement
The lower quarter y-balance test (YBT-LQ) is a test of dynamic balance in unilateral stance that has been deemed to be reliable and valid. The YBT-LQ consists of each patient standing on one leg and reaching as far as they can with their non-stance leg in the anterior, posteromedial and posterolateral direction while standing on the other foot on a centralized stance platform. The composite score is calculated as the sum of the three reach directions divided by 3 time the limb length and will be reported as a percentage of limb length.
Baseline (Pre-Operative) to 52 weeks following total knee replacement

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Change in Walking Speed From Baseline to 52 Weeks Following Total Knee Replacement.
Временное ограничение: Baseline and 52 weeks following total knee replacement
Each subject will complete three walking trials at a self-selected comfortable walking speed along a 5 meter walkway in order to record walking speed at each time point.
Baseline and 52 weeks following total knee replacement
Walking Speed at 6 Weeks Following Total Knee Replacement.
Временное ограничение: 6 weeks following total knee replacement
Each subject will complete three walking trials at a self-selected comfortable walking speed along a 5 meter walkway in order to record walking speed at each time point.
6 weeks following total knee replacement

Другие показатели результатов

Мера результата
Мера Описание
Временное ограничение
Change in University of California, Los Angeles (UCLA) Activity Score From Baseline to 52 Weeks Following Total Knee Replacement.
Временное ограничение: Baseline and 52 weeks following total knee replacement
The UCLA activity score is a validated patient reported outcome of overall physical activity. Results on a scale of 1 to 10, 1 is "Wholly Inactive, dependent on others, and can not leave residence" and 10 is "Regularly participates in impact sports".
Baseline and 52 weeks following total knee replacement
University of California, Los Angeles (UCLA) Activity Score at 6 Weeks Following Total Knee Replacement.
Временное ограничение: 6 weeks following total knee replacement
The UCLA activity score is a validated patient reported outcome of overall physical activity. Results on a scale of 1 to 10, 1 is "Wholly Inactive, dependent on others, and can not leave residence" and 10 is "Regularly participates in impact sports".
6 weeks following total knee replacement
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) Total From Baseline to 52 Weeks Following Total Knee Replacement.
Временное ограничение: Baseline (Pre-Operative) and 52 weeks following total knee replacement
The KOOS is a standardized and validated patient outcome score that assesses functional limitation in patient with knee problems. KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Baseline (Pre-Operative) and 52 weeks following total knee replacement
Change in Forgotten Joint Score (FJS) From 6 Weeks to 52 Weeks Following Total Knee Replacement.
Временное ограничение: 6 weeks and 52 weeks following total knee replacement
The FJS is a patient reported measure of how bothersome the total joint replacement is for them, how much it affects daily activity and how much they are aware of the implant. The FJS is a 12-question survey regarding functional outcome, pain, stability, daily living, activity and sport. Scoring is from 0 to 4 with 0 as the best outcome; a low score means high satisfaction. Not all questions must be answered to score, all responses are summed and the total is divided by number of completed items multiplied by 25, with the final result subtracted from 100. The score range is from 0 to 100 with the highest score of 100 indicating the best outcome (the joint is completely "forgotten") and 0 indicating the worst outcome.
6 weeks and 52 weeks following total knee replacement
Knee Society Score (KSS)
Временное ограничение: Baseline (Pre-Operative), 6 weeks and 52 weeks following total knee replacement
The KSS is a patient reported measure of knee function that is specific to patients who are scheduled to receive or have previously had a total knee replacement. This outcome measures both patient reported pain and function changes from prior to surgery through recovery. The score range is from 0 to 100. The highest score of 100 points will be obtained by a well-aligned knee with no pain, 125 degrees of motion, and negligible anteroposterior and mediolateral instability.
Baseline (Pre-Operative), 6 weeks and 52 weeks following total knee replacement
Sit to Stand Time
Временное ограничение: Baseline (Pre-Operative), 6 weeks and 52 weeks following total knee replacement
The sit to stand test requires patients to stand up and sit down as many times as possible in 10 seconds from a standard arm chair.
Baseline (Pre-Operative), 6 weeks and 52 weeks following total knee replacement
Timed Get up and go
Временное ограничение: Baseline (Pre-Operative), 6 weeks and 52 weeks following total knee replacement
The timed up and go requires a patient to rise from a chair walk three meters around a piece of tape and return to the chair again as quickly as possible.
Baseline (Pre-Operative), 6 weeks and 52 weeks following total knee replacement

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Duke University

Следователи

  • Главный следователь: Samuel S Wellman, MD, Duke University

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования

1 февраля 2013 г.

Первичное завершение (Действительный)

26 февраля 2016 г.

Завершение исследования (Действительный)

26 февраля 2016 г.

Даты регистрации исследования

Первый отправленный

12 марта 2013 г.

Впервые представлено, что соответствует критериям контроля качества

12 марта 2013 г.

Первый опубликованный (Оценивать)

14 марта 2013 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

2 июня 2017 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

28 апреля 2017 г.

Последняя проверка

1 апреля 2017 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • Pro00043737
  • 193447 (Другой номер гранта/финансирования: Stryker)

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. .

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