Evaluation of Clinical Outcomes and Patient Recovery in Patients Receiving TKA With Traditional Instrumentation Systems Compared to Full Arc of Motion Gap Balancing Using the Newton™ Knee Protocol: A Prospective Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Patient satisfaction with TKA using patient reported KOOS JR Questionnaire
研究概览
简要总结
Evaluation of clinical outcomes and patient recovery in patients receiving TKA with traditional instrumentation systems compared to full arc of motion gap balancing using the Newton TM Knee Protocol
详细描述
The purpose of this study is to evaluate patient outcomes, recovery, and patient/surgeon satisfaction of individuals who undergo a total knee arthroplasty (TKA) using mechanical instrumentation (non-navigated) compared to individuals who undergo a TKA with a tibia first gap balancing surgical workflow using the NewtonTM Knee Protocol and navigation-assistance (ExachtechGPS®).
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
- •Patients of Kaplan Joint Center, Newton Wellesley Hospital scheduled for TKA with a specific implant
排除标准
- •Patients may be excluded due to some medical conditions
结局指标
主要结局
Patient satisfaction with TKA using patient reported KOOS JR Questionnaire
时间窗: Pre-op, 4 weeks post-op, 12 weeks post-op, one year post-op
The KOOS, JR combines the pain, symptoms, and functional limitations into a single score.
Patient satisfaction with TKA using Oxford Knee Score (OKS) Questionnaire
时间窗: Pre-op, 4 weeks post-op, 12 weeks post-op, one year post-op
The OKS is a patient reported questionnaire that measures function and pain with a single score.
Patient satisfaction with TKA using Forgotten Joint Score (FJS) Questionnaire
时间窗: Pre-op, 4 weeks post-op, 12 weeks post-op, one year post-op
The Forgotten Joint Score assesses the ability of the patient to forget about their joint given successful treatment by assigning a single score to a series of questions.
Patient recovery from TKA using time from hospital stay to discharge
时间窗: Post-op measure in hours
The time of in-patient hospital stay will be measured (in hours).
Patient recovery from TKA by measuring number of outpatient visits
时间窗: One year post-op
Number of outpatient visits (scheduled and unscheduled)
Patient recovery from TKA by measuring number of PT visits
时间窗: One year post-op
Number of post-op PT visits
Patient recovery from TKA by measuring medication consumption
时间窗: One year post-op
Post-op, prescription medication will be recorded in number of pills and dosage
Patient recovery from TKA by measuring use of assisted walking devices
时间窗: One year post-op
Patient recovery from TKA by measuring the number of days using an assisted walking device following surgery.
次要结局
- Knee alignment and soft tissue balance(One time (during surgery))
研究者
Christopher M. Melnic, MD
Principal Investigator
Newton-Wellesley Hospital