A Prospective Randomized Trial to Examine the Effectiveness of KneeMD on Flexion Contracture in Total Knee Arthroplasty Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- AROM
研究概览
简要总结
The purpose of this study is to evaluate the effect of the KneeMD subject-controlled knee rehabilitation device on the incidence of postoperative flexion contracture.
详细描述
Postoperative flexion contracture (FC), defined as >10°, is the most common disabling early complication of primary total knee replacement (TKR) surgery, affecting up to 6% of all subjects. A knee flexion of 65° is required to walk, 70° is needed to lift an object from the floor, 85° to climb stairs, 95° for optimal sitting and standing, and 105° to tie shoelaces. With growing subject and physician expectations for function and range of motion (ROM) after surgery, FC complications have become an early measure of success in TKR surgery.
The purpose of this study is to evaluate the effect of the KneeMD subject-controlled knee rehabilitation device on the incidence of postoperative FC. The primary endpoints are the preoperative change in active range of motion (AROM) and the incidence of postoperative FC at 2 weeks. Secondary endpoints include the change in AROM in subjects with postoperative FC.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Measurable Knee Flexion Contracture, with deficit limiting Active Range of Motion (AROM) and Passive Range of Motion (PROM) by at least - 10°
- •18 years of age and older
- •Able to understand informed consent and willingness to conform to trial responsibilities
排除标准
- •Previous surgical treatment of knee, including tibial osteotomy
- •Botulinum Toxin Treatment within the last four months
- •Mechanical joint impingement
- •Neuromuscular pathologies such as epilepsy
- •Treatment with quinolone, antibiotic medication
- •Pregnant or nursing
- •Osteomyelitis or any orthopedic infection
- •Extensor mechanism dysfunction
- •Knee joint neuropathy
- •Previous Stroke or Brain Injury
结局指标
主要结局
AROM
时间窗: 4 weeks after randomization
Change in maximal active range of motion in
次要结局
- AROM(2 weeks postoperatively)