Evaluation of the Patient Reported Outcomes After Sensor-guided Total Knee Arthroplasty Under Spinal Anesthesia With Limited Motor-block.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Knee Society Score (KSS)
研究概览
简要总结
The purpose of this study will be to evaluate and compare patients undergoing total knee arthroplasty (TKA) with sensor guidance versus that of a standard technique. Each patient will be assessed for the difference between passive, soft tissue controlled, pressure balance and muscle activated pressure balance.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients will be screened for eligibility based on whether they have chronic knee pain as a result of an arthritis-related condition.
- •Patient with chronic knee pain who is indicated for total hip or knee replacement surgery
- •Patient is at least 50 years of age
- •Patient is willing to participate in pre- and postoperative surveys
排除标准
- •Failure to complete pre-operative surveys.
- •Revision Total Knee Arthroplasty
- •Prior ipsilateral knee surgery such as ligament reconstruction or osteotomy
- •Contralateral Total Knee Arthroplasty
- •Prior tibial plateau fracture
- •Ligamentous Insufficiency
- •History of fibromyalgia, chronic fatigue syndrome
研究组 & 干预措施
Standard of Care Spinal Surgery
Patients will be given spinal anesthesia with 2.6 mL of 0.5% isobaric bupivacaine.
干预措施: Spinal Surgery (Procedure)
Sensor Guided Spinal Surgery
The Verasense Knee System device (OrthoSensor inc., Dania Beach, Florida) is a sterile sensor system that replaces the tibial insert trials used during surgery. The sensor contains a microprocessor and integrated nanosensor system, which wirelessly transmits real-time data to a portable graphic display unit used for read-out of the data. The sensor measures and localizes peak load at the medial and lateral tibiofemoral joint interfaces. Loading data is thereby captured intra-operatively through the full range of movement (ROM) using the sensor system.
干预措施: Verasense Knee System device (Device)
结局指标
主要结局
Knee Society Score (KSS)
时间窗: Month 12 Post-Surgery
The Knee Society Score (KSS) comprises two sections (each worth 100 points) for a maximum 200 points. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. For each section, a score of 80-100 = excellent, 70-79 = good; 60-69 = fair; and \< 60 = poor.
Knee Injury and Osteoarthritis Outcome Score (KOOS)
时间窗: Month 12 Post-Surgery
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a self-reported outcome measure assessing the patient's opinion about the health, symptoms, and functionality of their knee. It is a 42-item questionnaire, including 5 subscales: symptoms, pain, function in daily living (ADLs), sports/recreation, and quality of life. The maximum score a patient can achieve is 100, indicating no knee problems. The minimum score is zero, indicating severe knee problems.
次要结局
未报告次要终点