NCT02839850进行中（未招募）不适用
Multi-Center Clinical Evaluation of the ATTUNE Cementless Rotating Platform Total Knee Arthroplasty
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 540
- 试验地点
- 40
- 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 of this study is to examine 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). This will be carried out for two configurations: cruciate retaining rotating platform (ATTUNE Cementless CR RP) and posterior stabilized rotating platform (ATTUNE Cementless PS RP).
详细描述
The secondary objectives of this study are:
- 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 and PS RP configurations using Kaplan-Meier survival analysis at 2yr and 5yrs.
- Evaluate primary, cementless ATTUNE TKA fixation through zonal radiographic analysis of the bone-implant interface at 6wk, 6mo, 1yr, and 2yr after surgery.
- Evaluate any changes in anatomic tibiofemoral, femoral component and tibial component alignment at 2 years compared to the first postoperative radiographs.
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 either English or one of the available translations.
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 investigation 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 compensation claims.
- •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 questionnaires 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 five (5) years life expectancy.
- •Uncontrolled gout
研究组 & 干预措施
ATTUNE Cementless RP TKA
Experimental
Subjects will receive a cementless, rotating platform total knee arthroplasty
干预措施: Cementless Total Knee Arthroplasty (Device)
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 (670-1033 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
- Survivorship(Minimum 5 years (1764-2190 days after surgery))
- Patient-reported Outcome: Pre-surgical/Post-surgical Patient's Knee Implant Performance (PKIP)(Minimum 2 years (670-1033 days after surgery))
- Patient-reported Outcome: Knee Injury and Osteoarthritis Outcome Score (KOOS)(Minimum 2 years (670-1033 days after surgery))
- Combination of Patient-reported and Clinical-reported Outcome: Knee Society 2011(Minimum 2 years (670-1033 days after surgery))
- Patient Reported Outcome: EuroQol 5D 3L questionnaire (EQ-5D-3L)(Minimum 2 years (670-1033 days after surgery))
- Modified VAS Pain Score: Pain and Satisfaction(Minimum 2 years (670-1033 days after surgery))
- Type and Frequency of Adverse Events (AEs) for all enrolled subjects(Pre-op (-90 to -1 days before surgery), 6 weeks (1-90 days after surgery), 6 months (91-303 days after surgery), minimum 1 year (304-669 days after surgery), minimum 2 years (670-1033 days after surgery), minimum 5 years (1764-2190 days after surgery))
- Implant fixation: Radiographic assessment of bone-implant interface performance(Minimum 2 years (670-1033 days after surgery))
- Evaluate changes in femoral component and tibial component alignment(Minimum 2 years (670-1033 days after surgery))
- Survivorship(Minimum 2 years (670-1033 days after surgery))
- Implant fixation: Radiographic assessment of bone-implant interface performance(6 weeks (1-90 days after surgery))
- Implant fixation: Radiographic assessment of bone-implant interface performance(6 months (91-303 days after surgery))
- Implant fixation: Radiographic assessment of bone-implant interface performance(Minimum 1 year (304-669 days after surgery).)
研究者
研究点 (40)
Loading locations...
相似试验
已完成
不适用
DSJ-2016-07 ATTUNE® Cementless CR RP JapanOsteoarthritisNCT03193034DePuy Orthopaedics81
已完成
不适用
Multi-Center Clinical Evaluation of the ATTUNE Cementless Rotating Platform Total Knee Arthroplasty In the Japanese Patient PopulatioOsteoarthritisJPRN-UMIN000026764Johnson & Johnson K.K. Medical Company80
进行中（未招募）
不适用
ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty PopulationPrimary Knee ArthroplastyNCT03153449DePuy Orthopaedics400
进行中（未招募）
不适用
ATTUNE Revision System in the Revision Total Knee Arthroplasty PopulationRevision Total Knee ArthroplastyNCT03153475DePuy Orthopaedics400
终止
不适用
ATTUNE Cementless FB Tibial Base Clinical StudyOsteoarthritis of the KneeNCT04630262DePuy Orthopaedics80