A PILOT STUDY: To Determine the Gait and Functional Improvement in Total Knee Arthroplasty With Use of Orthosensor™ VERASENSE™ Knee System for Soft Tissue Balancing.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Proportion of patients with improved function as measured by standardized knee scores.
研究概览
简要总结
This is an observational study to understand the effects of soft-tissue balancing on gait, function and rehabilitation potential after sensor-assisted Total Knee Arthroplasty
详细描述
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 to 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) and 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
- Treatment
- 盲法
- Single (Investigator)
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
- 否
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 Minimum age: 45 Maximum age: 80
- •Subject is likely to be available for all study visits
- •Subject is able and willing to sign the informed consent and follow study procedures
- •Exclusion Criteria
- •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 f ) flexion contracture of more than 20 degrees
排除标准
- 未提供
结局指标
主要结局
Proportion of patients with improved function as measured by standardized knee scores.
时间窗: 18 months
Proportion of patients with improvement in gait.
时间窗: 18 months
Proportion of patients not requiring long term rehabilitation.
时间窗: 18 months
次要结局
未报告次要终点