NCT03193034已完成不适用
Multi-Center Clinical Evaluation of the ATTUNE® Cementless Rotating Platform Total Knee Arthroplasty in the Japanese Patient Population
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 8
- 主要终点
- Patient-reported Outcome:Knee Injury and Osteoarthritis Outcome Score Activities of Daily Living (KOOS ADL)
研究概览
简要总结
The primary objective is to investigate the change from pre-operative baseline to two year postoperative functional performance improvement for the ATTUNE® primary, cementless TKA RP system as measured with the KOOS questionnaire (KOOS-ADL sub-score) in the Japanese patient population.
详细描述
- Evaluate change from preoperative baseline in post-operative outcomes using additional patient reported measures at 2 years: PKIP (overall and sub-scores), KOOS (overall and sub-scores), AKS and EQ-5D-3L.
- Evaluate change from preoperative baseline in pain and satisfaction over time as measured using a modified VAS Pain Score (discrete numbers rather than a continual scale) at 2yr.
- Evaluate type and frequency of Adverse Events
- Evaluate survivorship of the ATTUNE® Primary Cementless TKA system for the CR RP configurations using Kaplan-Meier survival analysis at 1 and 2yrs.
- Evaluate primary, cementless ATTUNE® TKA fixation through zonal radiographic analysis of the bone-implant interface at 6wk, 1yr, and 2yrs after surgery.
- Evaluate any changes in anatomic tibiofemoral, femoral component and tibial component alignment at 2 years compared to the first postoperative radiographs.
- Radiographically characterize the postoperative ATTUNE patellar component alignment and positioning in Japanese population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
An independent radiographic reviewer will be assessing all radiographs from the study.
入排标准
- 年龄范围
- 22 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is male or female and between the ages of 22 and 80 years at the time of surgery, inclusive.
- •Subject was diagnosed with NIDJD.
- •Subject, in the opinion of the Investigator, is a suitable candidate for cementless primary TKA using the devices described in this CIP with either resurfaced or non-resurfaced patellae.
- •Subject that is willing to give voluntary, written informed consent to participate in this clinical investigation and authorize the transfer of his/her information to the Sponsor .
- •Subject is currently not bedridden
- •Subject, in the opinion of the Investigator, is able to understand this clinical investigation and is willing and able to perform all study procedures and follow-up visits and co-operate with investigational procedures.
- •Subject is able to read, and comprehend the Informed Consent Document as well as complete the required PROs in Japanese.
排除标准
- •The Subject is a woman who is pregnant or lactating. -Contralateral knee has already been enrolled in this study
- •Subject had a contralateral amputation.
- •Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement), patellectomy, high tibial osteotomy or primary TKA in affected knee.
- •Subject is currently diagnosed with radicular pain from the spine that radiates into the limb to receive TKA.
- •Subject has participated in a clinical investig ation with an investigational product (drug or device) in the last three (3) months.
- •Subject is currently involved in any personal injury litigation, medical-legal or Worker's Acc ident Insurance claims (similar to Workers Compensation in USA).
- •Subject, in the opinion of the Investigator, is a drug or alcohol abuser (in the last 5 years) or has a psychological disorder that could affect their ability to complete patient reported question naires or be compliant with follow-up requirements.
- •Subject was diagnosed and is taking prescription medications to treat a muscular disorder that limits mobility due to severe stiffness and pain such as fibromyalgia or polymyalgia.
- •Subject has a significant neurological or musculoskeletal disorder(s) or disease that may adversely affect gait or weight bearing (e.g., muscular dystrophy, multiple sclerosis, Charcot disease).
- •Subject is suffering from inflammatory arthritis (e.g., rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, etc.).
- •Subject has a medical condition with less than two (2) years life expectancy.
- •Uncontrolled gout
结局指标
主要结局
Patient-reported Outcome:Knee Injury and Osteoarthritis Outcome Score Activities of Daily Living (KOOS ADL)
时间窗: Minimum 2 years (670-912 days after surgery)
The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient self-administered questionnaire that consists of 42 questions and include the WOMAC Osteoarthritis index. The KOOS consists of 5 subscales: pain, other symptoms, activities of daily living (ADL), sport and recreational function and knee related quality of life. Each question has 5 Likert-like response options. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
次要结局
- Modified VAS Pain Score: Pain and Satisfaction(Minimum 2 years (670-912 days after surgery))
- Implant fixation: Radiographic assessment of bone-implant interface performance(6 weeks (1-303 days after surgery), minimum 1 year (304-669 days after surgery), minimum 2 years (670-912 days after surgery))
- Patient-reported Outcome: Knee Injury and Osteoarthritis Outcome Score (KOOS)(Minimum 2 years (670-912 days after surgery))
- Survivorship(Minimum 1 year (304-669 days after surgery), minimum 2 years (670-912 days after surgery))
- Patient-reported Outcome: Pre-surgical/Post-surgical Patient's Knee Implant Performance (PKIP)(Minimum 2 years (670-912 days after surgery))
- Combination of Patient-reported and Clinical-reported Outcome: Knee Society 2011(Minimum 2 years (670-912 days after surgery))
- Patient Reported Outcome: EuroQol 5D 3L questionnaire (EQ-5D-3L)(Minimum 2 years (670-912 days after surgery))
- Type and Frequency of Adverse Events (AEs) for all enrolled subjects(Pre-op (-180 to -1 days before surgery), 6 weeks (1-303 days after surgery), minimum 1 year (304-669 days after surgery), minimum 2 years (670-912 days after surgery))
- Evaluate changes in femoral component and tibial component alignment(Minimum 2 years (670-912 days after surgery))
- Radiographically characterize the postoperative ATTUNE patellar component alignment and positioning in Japanese population.(Minimum 1 year (304-669 days after surgery))
研究者
研究点 (8)
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