Randomized Control Trial Comparing Zimmer Biomet Persona Medial Congruent Versus Posterior Stabilized Total Knee Arthroplasty for Treatment of Knee Arthritis Using the ROSA Knee System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- European Quality of Life Five Dimension (EQ-5D) Score
研究概览
简要总结
A randomized, controlled study comparing two total knee implant devices, Persona medial congruent (MC) vs posterior stabilized (PS). These surgeries will be performed using the ROSA robotic system. Patients will be followed up to 5 years.
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 ≥18 years of age
- •Patients scheduled an elective primary TKA for a diagnosis of osteoarthritis or inflammatory arthritis using the ROSA Knee System.
- •Patient is willing to cooperate and follow study protocol and visit schedule
- •Subject has access to a device is capable of pairing to the Apple Watch, supporting application updates and is compatible with the mymobility App.
排除标准
- •Patient is pregnant
- •Patient is unable to provide written consent
- •Revision TKA
- •History of prior infection in the affected knee
- •History of prior open surgery with significant hardware in place on the affected knee (i.e. prior distal femur or proximal tibia fracture or osteotomy)
- •Preoperative diagnosis of post-traumatic arthritis, avascular necrosis, or fracture
研究组 & 干预措施
Total Knee Arthroplasty (TKA) performed using a posterior stabilized bearing design
干预措施: Zimmer-Biomet Persona Posterior-Stabilized (PS) Bearing Design (Device)
Total Knee Arthroplasty (TKA) performed using a medial congruent articular bearing surface design
干预措施: Zimmer-Biomet Persona Medial Congruent (MC) Bearing Design (Device)
结局指标
主要结局
European Quality of Life Five Dimension (EQ-5D) Score
时间窗: Year 20
The EQ-5D comprises five questions on mobility, self care, pain, usual activities, and psychological status with three possible answers for each item (1=no problem, 2=moderate problem, 3=severe problem. A summary index with a maximum score of 1 can be derived from these five dimensions by conversion with a table of scores. The maximum score of 1 indicates the best health state, by contrast with the scores of individual questions, where higher scores indicate more severe or frequent problems. In addition, there is a visual analogue scale (VAS) to indicate the general health status (0-100) with 100 indicating the best health status.
Forgotten Joint Score (FJS)
时间窗: Year 20
FJS is a patient-reported outcome measure intended to determine a patient's ability to "forget" about their affected joint after surgery or treatment. FJS consists of 12 questions - the total score range is 0-100. The higher the score, the less the patient is aware of their affected joint when performing daily activities.
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR)
时间窗: Year 20
KOOS, JR contains 7 items from the original KOOS survey. Items are coded from 0 to 4, none to extreme respectively. KOOS, JR is scored by summing the raw response (range 0-28) and then converting it to an interval score. The interval score ranges from 0 to 100 where 0 represents total knee disability and 100 represents perfect knee health.
次要结局
- Change in Average gait speed(Baseline, Year 2)
- Change in Average daily flight count(Baseline, Year 2)
- Change in Average daily step count(Baseline, Year 2)