To Determine the Economic and Functional Impact of Peri-Operative Extension Assist Pneumatic Bracing for Primary Total Knee Arthroplasty (TKA) Non-Inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Number of Physical Therapy Visits
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 50 years or older
排除标准
- •BMI > 40
- •Radiographic deformity of greater than 10 degrees
研究组 & 干预措施
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.
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.
干预措施: OCSI Rehabilitator brace (Device)
结局指标
主要结局
Number of Physical Therapy Visits
时间窗: Total number of visits from date of surgery to 12 weeks after surgery
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.
次要结局
- Timed up and go Test (Timed Measurement)(Change from baseline to 12 weeks after surgery)
- Visual Analog Scale (VAS) for Pain (0-10 Scale)(Change from baseline to 12 weeks after surgery)
- Timed Stair Climb (Timed Measurement Over Fixed Distance)(Change from baseline to 12 weeks after surgery)
- One-leg Stance Time (Timed Measurement)(Change from baseline to 12 weeks after surgery)
- 6 Minute Walk Test (Distance Measurement)(Change from baseline to 12 weeks after surgery)
- Amount of Pain Medication Used(Change from baseline to 12 weeks after surgery)
- Knee Society Score Questionnaire(Change from baseline to 12 weeks after surgery)
- Knee Injury and Osteoarthritis Outcome Score Jr. (KOOS Jr.) Questionnaires(Change from baseline to 12 weeks after surgery)
- Hospital for Special Surgery (HSS) Score (0-100 Scale)(Change from baseline to 12 weeks after surgery)
- Type of Pain Medication Used(Change from baseline to 12 weeks after surgery)
研究者
Carlos Higuera-Rueda
Staff Surgeon
The Cleveland Clinic