14022 ATTUNE 无水泥 RP 临床性能评估
ATTUNE 无骨水泥旋转平台全膝关节置换术的多中心临床评价
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).
研究概览
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
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Alberta
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Calgary、Alberta、加拿大、T2N 2T9
- Foothills Medical Centre, University of Calgary
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Upper Austria
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Ried im Innkreis、Upper Austria、奥地利、4910
- Krankenhaus der Barmherzigen Schwestern Ried im Innkreis
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Garmisch-Partenkirchen、德国、82467
- Klinikum Garmisch-Partenkirchen GmbH
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Christchurch、新西兰、8083
- University of Otago
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Salouël、法国、80480
- Sevice de Chirurgie Orthoedique et Traumatologique
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Cedex
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Brest、Cedex、法国、29285
- CHU de la Cavale Blanche
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Cork、爱尔兰、T12 X23H
- South Infirmary Victoria University Hospital
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Colorado
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Denver、Colorado、美国、80210
- Colorado Joint Replacement
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Florida
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DeLand、Florida、美国、32720
- Florida Research Associates
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New Hampshire
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Lebanon、New Hampshire、美国、03756
- Dartmouth-Hitchcock Medical Center
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New London、New Hampshire、美国、03257
- New London Hospital
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New Jersey
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Egg Harbor、New Jersey、美国、08234
- Rothman Institute
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New York
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Brooklyn、New York、美国、11203
- SUNY downstate Medical Center
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North Carolina
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Chapel Hill、North Carolina、美国、27599
- UNC Chapel Hill
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Tennessee
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Kingsport、Tennessee、美国、37660
- Associated Orthopaedics of Kingsport
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Texas
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Lubbock、Texas、美国、49416
- Texas Tech University Heath Science Center
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Virginia
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Newport News、Virginia、美国、23606
- Hampton Roads Orthopaedics and Sports Medicine
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Nottingham、英国、NG5 1PB
- Nottingham University Hospitals NHS Trust
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Lancashire
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Wigan、Lancashire、英国、WN6 9EP
- Wrightington Hospital
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North Brabant
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Helmond、North Brabant、荷兰、5707 HA
- Elkerliek Ziekenhuis
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：ATTUNE Cementless RP TKA
Subjects will receive a cementless, rotating platform total knee arthroplasty |
Patients will undergo a primary total knee replacement using one of the two configurations of the ATTUNE Cementless knee (CR RP or PS RP) |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Patient-reported Outcome: Knee Injury and Osteoarthritis Outcome Score Activities of Daily Living (KOOS ADL)
大体时间：Minimum 2 years (670-1033 days after surgery)
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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. |
Minimum 2 years (670-1033 days after surgery)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Patient-reported Outcome: Pre-surgical/Post-surgical Patient's Knee Implant Performance (PKIP)
大体时间：Minimum 2 years (670-1033 days after surgery)
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The Pre Surgical and/or Post-surgical Patient's Knee Implant Performance (PKIP) questionnaire is a patient self-administered questionnaire that consists of 25 questions relating to the patient's awareness of their knee. Questions include the patient's self-confidence about the current status of their knee performance, stability, and overall satisfaction. Each question has a 5, 6 or 10 Likert- like response option. |
Minimum 2 years (670-1033 days after surgery)
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Patient-reported Outcome: Knee Injury and Osteoarthritis Outcome Score (KOOS)
大体时间：Minimum 2 years (670-1033 days after surgery)
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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. |
Minimum 2 years (670-1033 days after surgery)
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Combination of Patient-reported and Clinical-reported Outcome: Knee Society 2011
大体时间：Minimum 2 years (670-1033 days after surgery)
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The Knee Society Score is a self-administered questionnaire. The subject completes questions regarding: Symptoms (3 questions), Patient Satisfaction (5 questions), Patient Expectations (3 questions), Functional Activities (5 questions), Standard Activities (6 questions), Advanced Activities (5 questions), and Discretionary Knee Activities ( 4 questions). The surgeon completes questions regarding objective knee indicators. Likert responses are used, typically with five response options. |
Minimum 2 years (670-1033 days after surgery)
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Patient Reported Outcome: EuroQol 5D 3L questionnaire (EQ-5D-3L)
大体时间：Minimum 2 years (670-1033 days after surgery)
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EuroQol 5D 3L questionnaire is a standardized instrument for use as a measure of health outcome that is designed for completion by the subject. |
Minimum 2 years (670-1033 days after surgery)
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Modified VAS Pain Score: Pain and Satisfaction
大体时间：Minimum 2 years (670-1033 days after surgery)
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VAS Pain Score is a standardized instrument for use as a measure of pain and satisfaction that is designed for completion by the subject. This modified version has scores that are discrete numbers rather than a continual scale |
Minimum 2 years (670-1033 days after surgery)
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Type and Frequency of Adverse Events (AEs) for all enrolled subjects
大体时间：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)
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All Serious AEs must be reported to Sponsor. All device-related or procedure-related adverse events must be reported to Sponsor. |
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)
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Survivorship
大体时间：Minimum 2 years (670-1033 days after surgery)
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Kaplan-Meier survival analysis will be used to calculate the survivorship of all 2 configurations (CR RP, PS RP) |
Minimum 2 years (670-1033 days after surgery)
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Survivorship
大体时间：Minimum 5 years (1764-2190 days after surgery)
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Kaplan-Meier survival analysis will be used to calculate the survivorship of all 2 configurations (CR RP, PS RP) |
Minimum 5 years (1764-2190 days after surgery)
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Implant fixation: Radiographic assessment of bone-implant interface performance
大体时间：6 weeks (1-90 days after surgery)
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Radiographic success is defined as: absence of progressive radiolucent lines greater than or equal to 2mm in any one zone; absence of lytic lesions in any zone; absence of individual component position change >3degrees in any plane. |
6 weeks (1-90 days after surgery)
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Implant fixation: Radiographic assessment of bone-implant interface performance
大体时间：6 months (91-303 days after surgery)
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Radiographic success is defined as: absence of progressive radiolucent lines greater than or equal to 2mm in any one zone; absence of lytic lesions in any zone; absence of individual component position change >3degrees in any plane. |
6 months (91-303 days after surgery)
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Implant fixation: Radiographic assessment of bone-implant interface performance
大体时间：Minimum 1 year (304-669 days after surgery).
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Radiographic success is defined as: absence of progressive radiolucent lines greater than or equal to 2mm in any one zone; absence of lytic lesions in any zone; absence of individual component position change >3degrees in any plane. |
Minimum 1 year (304-669 days after surgery).
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Implant fixation: Radiographic assessment of bone-implant interface performance
大体时间：Minimum 2 years (670-1033 days after surgery)
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Radiographic success is defined as: absence of progressive radiolucent lines greater than or equal to 2mm in any one zone; absence of lytic lesions in any zone; absence of individual component position change >3degrees in any plane. |
Minimum 2 years (670-1033 days after surgery)
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Evaluate changes in femoral component and tibial component alignment
大体时间：Minimum 2 years (670-1033 days after surgery)
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Radiographs will be reviewed by an independent radiographic reviewer (IRR) in order to minimize bias of radiographic outcomes. Data from the IRR radiographic evaluations will be used to evaluate femoral and tibial component alignment over time. |
Minimum 2 years (670-1033 days after surgery)
|
合作者和调查者
调查人员
- 研究主任：Sukhjeet Kaur、Sponsor GmbH
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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