Economic and Functional Impact of Peri-Operative Bracing for Primary Total Knee Arthroplasty (TKA)
2019年9月24日 更新者:Carlos Higuera-Rueda、The Cleveland Clinic
To Determine the Economic and Functional Impact of Peri-Operative Extension Assist Pneumatic Bracing for Primary Total Knee Arthroplasty (TKA) Non-Inferiority Trial
While bracing has been shown to be beneficial for patients with osteoarthritis (OA) in terms of function and strength, whether these unloader braces are also similarly beneficial after total knee arthroplasty (TKA) surgery needs to be examined.
Therefore the investigators questioned whether wearing a brace that has previously been shown to increase strength and function in OA patients can also increase strength and function in patients after TKA.
研究概览
研究类型
介入性
注册 (实际的)
9
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Ohio
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Cleveland、Ohio、美国、44195
- Cleveland Clinic
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
50年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
Age: 50 years or older
Exclusion Criteria:
- BMI > 40
- Radiographic deformity of greater than 10 degrees
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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无干预:Control group
Subjects will receive two out-patient physical therapy (PT) visits per week for 2 weeks, followed by additional PT visits at clinician's discretion after TKA.
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实验性的:Bracing group
Subjects will be fitted with the Ongoing Care Solutions, Inc (OCSI) Rehabilitator brace prior to surgery.
This brace will be worn for 6 weeks before surgery.
The brace will be worn again after surgery ~10 days after surgery or when staples are removed until the end of the study.
Participants will also have two PT visits per week for 2 weeks, followed by additional PT visits at clinician's discretion.
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Guardian Brace features the innovative Rehabilitator™ line of gait correcting, leg strengthening braces.
Rehabilitator™ Knee Braces are clinically proven to reduce UNBRACED pain, strengthen the affected leg, and significantly improve function after only 90 days of brace wear.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Number of Physical Therapy Visits
大体时间:Total number of visits from date of surgery to 12 weeks after surgery
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Investigators will monitor the total number of physical therapy visits that was necessary to return to normal function between the control and bracing group and how it relates to overall cost.
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Total number of visits from date of surgery to 12 weeks after surgery
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Visual Analog Scale (VAS) for Pain (0-10 Scale)
大体时间:Change from baseline to 12 weeks after surgery
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Visual Analog Scale is a a pain scale assessment instrument that has been widely used to allow adult patients to report their pain level in musculoskeletal research studies.
It is a continuous scale comprised of a horizontal line, 10 centimeters (100 mm) in length, anchored by 2 two ends representing the extremes of measurements with 0 point representing no pain and 10 representing the worst pain a patient may have had.
Therefore, starting from zero point, increasing numbers demonstrate worse pain.
Patient can pick a point on the scale that they believe represent their pain level at a given moment.
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Change from baseline to 12 weeks after surgery
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Timed up and go Test (Timed Measurement)
大体时间:Change from baseline to 12 weeks after surgery
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Used to assess a person's mobility and balance.
It is measured in time units (seconds or minutes) using a stopwatch by a study personnel.
To perform, the patient sits back in a standard arm chair and a line 3 meters, or 10 feet away on the floor is identified.
At the investigator mark, the stopwatch is started and the patient is asked to stand up from chair, walk to the end of the line and come back to his chair at normal pace.
The results is the time in seconds needed for the patient to perform the test (getting up from chair and coming back to it as timed by the investigator's stopwatch)
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Change from baseline to 12 weeks after surgery
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Timed Stair Climb (Timed Measurement Over Fixed Distance)
大体时间:Change from baseline to 12 weeks after surgery
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Used to assess a person's mobility and balance
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Change from baseline to 12 weeks after surgery
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One-leg Stance Time (Timed Measurement)
大体时间:Change from baseline to 12 weeks after surgery
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Used to assess a person's balance.
Performed with eyes open and arms on hips.
The patient is asked to stand unassisted on one leg and is timed in seconds (using stopwatch) from the time one foot is flexed off the floor to the time when it touches the ground or the standing leg or an arm leaves the hips.
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Change from baseline to 12 weeks after surgery
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6 Minute Walk Test (Distance Measurement)
大体时间:Change from baseline to 12 weeks after surgery
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Used to assess a person's endurance and aerobic capacity.
The score of the test is distance a patient walks in 6 minutes.
Longer distances walked by the patient in 6 minutes correlates with better performance.
Distance is measured using distance measuring wheel.
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Change from baseline to 12 weeks after surgery
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Knee Society Score Questionnaire
大体时间:Change from baseline to 12 weeks after surgery
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Clinical outcome questionnaire developed by the consensus of the Knee Society.
It comprises, a "Knee score" and a "Functional score."
The Knee score assesses pain, stability, and range of motion.
A maximum score of 100 is achieved by a painless, well-aligned knee with 125° range of motion, with neither anteroposterior nor mediolateral instability.
Deductions are made for flexion contracture, extension lag, and malalignment.
The Functional score assesses walking distance and stair climbing.
A maximum score of 100 is assigned to individuals who can walk unlimited distances and can climb up and down stairs normally.
Deductions are made for use of a walking stick or crutches.
Therefore, higher scores correlate with better function and outcome.
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Change from baseline to 12 weeks after surgery
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Knee Injury and Osteoarthritis Outcome Score Jr. (KOOS Jr.) Questionnaires
大体时间:Change from baseline to 12 weeks after surgery
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Clinical outcome questionnaire that measure joint-specific pain and physical function.
It has seven questions that focus on three categories: joint pain, stiffness, and function, in daily living.
Raw scores are added up (range 0-28) and converted to an interval score (0-100) using an interval table.
The interval score represents a patients total joint disability where 0 corresponds to total joint disability and 100 perfect joint health.
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Change from baseline to 12 weeks after surgery
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Hospital for Special Surgery (HSS) Score (0-100 Scale)
大体时间:Change from baseline to 12 weeks after surgery
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Clinical outcome assessment tool.
It is based on a total of 100 points.
The score is divided into seven categories, which include pain, function, range of motion, muscle strength, flexion deformity, instability, and subtractions.
The knee is initially given a score of 0, and additions or subtractions are made according to specific criteria.
The higher the score, the better the outcome.
Approximately 50% of the score is based on a patient interview and the remaining on physical exam.
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Change from baseline to 12 weeks after surgery
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Type of Pain Medication Used
大体时间:Change from baseline to 12 weeks after surgery
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Investigators will monitor the medical record for types of pain medications used.
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Change from baseline to 12 weeks after surgery
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Amount of Pain Medication Used
大体时间:Change from baseline to 12 weeks after surgery
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Investigators will monitor the medical record for the amount of pain medication used
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Change from baseline to 12 weeks after surgery
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅:Spindler Kurt, MD、Department Chair
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年10月5日
初级完成 (实际的)
2018年1月1日
研究完成 (实际的)
2018年1月1日
研究注册日期
首次提交
2017年7月10日
首先提交符合 QC 标准的
2017年8月21日
首次发布 (实际的)
2017年8月24日
研究记录更新
最后更新发布 (实际的)
2019年10月9日
上次提交的符合 QC 标准的更新
2019年9月24日
最后验证
2019年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
膝关节病的临床试验
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Swansea University完全的
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Scripps Translational Science Institute完全的
OCSI Rehabilitator brace的临床试验
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National Taiwan University HospitalBaui Biotech Co., Ltd.招聘中
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University of AlbertaAmerican Orthotic and Prosthetic Association暂停
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Walter van der WeegenGelre Hospitals; Medinova Clinics招聘中
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Case Western Reserve UniversityAkron Children's Hospital; Kent State University完全的