NCT03840096已完成不适用
Effect of Augmenting a Standard Total Knee Pathway Protocol With a 12-week Peri-Operative Program of BREG Flex
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Patient Acceptable Symptoms State (PASS)
研究概览
简要总结
Patient outcomes following total knee replacement and standard physical therapy will be compared between subjects who use the Breg Flex study device vs those who do not. Subjects will be evaluated for knee range of motion, strength and patient reported outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals who are scheduled for Total Knee Arthroplasty by a single surgeon (Burnikel)
- •Individuals who are at least 55 years of age
- •Individuals with a body mass index (BMI) <45
- •Must be able and willing to complete all study assessments and to be followed for the full course of the study.
- •Must be able to read, write and follow instructions in English.
- •Must be able and willing to provide informed consent.
- •Must be willing and able to attend the pre-op assessment
排除标准
- •Individuals with a history of any underlying neurological conditions
- •Individuals with a history of stroke
- •Individuals with a history of neurological disorder that affects lower extremity function (stroke, peripheral neuropathy, Parkinson's disease, multiple sclerosis, etc.)
- •Individuals with physical conditions which would make them unable to perform study procedures
- •Pregnant women or inadequate precautions to prevent pregnancy
- •Diagnosis of a medical condition that would contraindicate treatment with the product, e.g. skin lesions at electrode site.
- •Individuals with a diagnosis of inflammatory arthritis (Rheumatoid arthritis, gout or psoriatic arthritis)?
- •Individuals with muscle diseases (i.e. muscular dystrophy)
- •Visible skin injury or disease on their legs
- •Principal investigator for this study, or member of study staff
结局指标
主要结局
Patient Acceptable Symptoms State (PASS)
时间窗: 52 weeks post op
Patient reported outcome recording patient satisfaction with level of recovery. Patients report that they are either satisfied or not.
次要结局
- Knee Osteoarthritis Outcome Score-JR (KOOS-JR)(6 week and 1 week preoperatively and 3 ,6, 12, 52 week post op)
- Range of motion(6 week and 1 week preoperatively and 3 ,6, 12 week post op)
- Number of Participant Physical Therapy Visits(3 ,6, 12, 52 week post op)
- Strength(6 week and 1 week preoperatively and 3 ,6, 12 week post op)
研究者
研究点 (4)
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