NCT02290119终止不适用
PILOT STUDY: Gait and Functional Improvement in Total Knee Arthroplasty With the Use of Verasense for Soft Tissue Balancing: A Randomized, Double-Blind, Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Rehabilitation Potential
研究概览
简要总结
The primary objectives of this study are to understand the effects of soft-tissue balancing on Gait, function and rehabilitation potential after sensor-assisted Total Knee Arthroplasty and correlate Intra-operative subjective feel with OrthoSensor Outputs
Secondary objectives are to quantify and observe:
- Pain medication use
- Swelling
- Muscle strength and girth
- Gait efficiency
- Patient satisfaction
- Activity levels, functional return (i.e., back to work, resume normal activities)
- Patient perception of a balanced knee
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject must be a candidate for a primary PCL retaining total knee arthroplasty
- •Subject must be diagnosed with one or more of the following conditions: osteoarthritis, avascular necrosis, rheumatoid or other inflammatory arthritis, post-traumatic arthritis
- •Subject is between the age of 45 - 80 years
- •Subject is likely to be available for all study visits
- •Subject is able and willing to sign the informed consent and follow study procedures
排除标准
- •Prior total knee arthroplasty, ligament insufficiencies, prior surgeries such as ACL or PCL reconstructions, posterolateral reconstructions, osteotomies, tibia plateau fractures
- •Range of Motion less than 90 degrees, flexion contracture of more than 20 degrees
研究组 & 干预措施
Control - Without the use of Verasense
Sham Comparator
Total Knee Replacement without the use of intraoperative sensors
干预措施: Control - Without the use of Verasense (Procedure)
Sensor-assisted TKR (Verasense)
Active Comparator
Total Knee Replacement with the use of intraoperative sensors
干预措施: Sensor-assisted TKR (Verasense) (Device)
结局指标
主要结局
Rehabilitation Potential
时间窗: 6 Months
次要结局
- Knee Society Pain and Functional Scoring (KSS)(6 month)
- 3D Gait Analysis velocity(6 Month)
- Forgotten Joint Score (FJS)(6 month)
研究者
研究点 (1)
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