Comparative Effectiveness of the Journey Total Knee Arthroplasty Relative to Two Standard of Care Total Knee Arthroplasty Prostheses: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- knee abduction-adduction range of motion (ROM) during level treadmill walking
研究概览
简要总结
The purpose of the study is to determine if knee replacement performed using Journey II implant is different from two other standard-of-care knee replacements using Stryker and Zimmer in terms of knee movements and forces, walking patterns, pain, and function after surgery.
详细描述
Background
Osteoarthritis is the most prevalent form of arthritis, with weight-bearing joints, particularly the knee commonly affected. Osteoarthritis is a leading cause of mobility disability and is associated with functional loss in adults. Total knee arthroplasty (TKA) is cost-effective and successful for those with end-stage knee osteoarthritis. In 2016/17, about 67,169 TKAs were performed in Canada, an increase of 16% since 2012/13.
Justification
TKA aims to improve joint mechanics as well as knee pain and function. Patients indicate that their primary expectations following TKA are improved pain and walking ability. Most TKA implants are fixed bearing (such as Stryker and Zimmer) with no movement of the implant with knee motion. The Journey II TKA has a medial pivot function that may improve patient outcomes further, by replicating meniscal function. However, this has not yet been proven as it would require more specific measurement of knee kinetics and kinematics such as we propose here.
The outcome of this study will provide information about knee pain, movements (kinematics) and forces (kinetics) and walking patterns after TKA using different implants. Through this study, we should be able to inform future research on rehabilitation protocols to alter knee movements after TKA, while enhancing patients' function and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant has signed an approved informed consent form.
- •Participant is a male or non-pregnant female and aged 50 to 75 years at the time of study device implantation.
- •Participant has a diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD).
- •Participant is a candidate for a primary posterior-stabilized total knee replacement.
- •Participant is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
排除标准
- •Participant has a Body Mass Index (BMI) ≥ 40 kg/m
- •Participant has a varus or valgus deformity greater than 15º or flexion contracture greater than 20º or knee flexion range of motion < 90º in either lower extremity.
- •Participant has an active or suspected latent infection in or about the affected knee joint at time of study device implantation.
- •Participant has received any orthopaedic surgical intervention to the lower extremities within the past 6 months or is expected to require any orthopaedic surgical intervention to the lower extremities, other than the TKA, within the next year.
- •Participant requires bilateral total knee replacements, or has a history of contralateral partial or total knee replacement within the past 6 months.
- •Participant has other medical conditions which limit the ability to evaluate the safety and efficacy of the device.
- •Participant requires revision surgery of a previously implanted total knee replacement or knee fusion to the affected joint.
- •Participant has a known sensitivity to device materials.
研究组 & 干预措施
Journey II
Smith and Nephew Richards (SNR) Journey II Knee prosthesis
干预措施: Journey II (Device)
Stryker
Stryker Triathlon Total Knee prosthesis
干预措施: Stryker (Device)
Zimmer
Zimmer Persona® The Personalized Knee prosthesis
干预措施: Zimmer (Device)
结局指标
主要结局
knee abduction-adduction range of motion (ROM) during level treadmill walking
时间窗: 1 year post-operative
Angle of knee measured using the Computer-Assisted Rehabilitation Environment (CAREN). Unit: Degree
Max moment of knee flexion-extension during level treadmill walking
时间窗: 1 year post-operative
Knee moment measured using the Computer-Assisted Rehabilitation Environment (CAREN). Unit: Newton meter
Max velocity of knee flexion-extension during level treadmill walking
时间窗: 1 year post-operative
Knee velocity measured using the Computer-Assisted Rehabilitation Environment (CAREN). Unit: degree/s
Max velocity of knee abduction-adduction during level treadmill walking
时间窗: 1 year post-operative
Knee velocity measured using the Computer-Assisted Rehabilitation Environment (CAREN). Unit: degree/s
knee flexion-extension range of motion (ROM) during level treadmill walking
时间窗: 1 year post-operative
Angle of knee measured using the Computer-Assisted Rehabilitation Environment (CAREN). Unit: Degree
Max moment of knee abduction-adduction during level treadmill walking
时间窗: 1 year post-operative
Knee moment measured using the Computer-Assisted Rehabilitation Environment (CAREN). Unit: Newton meter
次要结局
- Walking velocity during level treadmill walking(1 year post-operative)
- The new Knee Society Clinical Rating Scores (KSCRS)(2 years post-operative)
- UCLA activity-level rating (UCLA)(2 years post-operative)
- Forgotten Joint Score(2 years post-operative)
- Cadence during level treadmill walking(1 year post-operative)
- Stride length during level treadmill walking(1 year post-operative)
- Euro-Quality of Life five dimensions questionnaire (EQ-5D)(2 years post-operative)
- knee injury and osteoarthritis outcome score (KOOS)(2 years post-operative)