Multi-Center Clinical Evaluation of the ATTUNE Revision System in Complex Primary Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 400
- 试验地点
- 45
- 主要终点
- KOOS ADL
研究概览
简要总结
Five-year, Prospective, multi-center, non-randomized, non-controlled study of the ATTUNE® Revision total knee prostheses, utilizing the fixed bearing (FB) and rotating platform (RP) tibial component with the posterior stabilizing (PS) femoral component in complex primary total knee arthroplasty.
详细描述
Within primary TKA, there are factors that lead to more complex procedures that include patients with high BMIs, advanced preoperative deformities and ligamentous laxity. Such cases may require the surgeon to treat using ancillary components, such as stems and/or augments and/or additional constraint.
This post-market study will evaluate the short/medium term clinical performance and medium term survivorship of the ATTUNE Revision system system, which includes instrumentation, in complex primary TKA. The study is designed as a worldwide non-comparative, multi-center study with each site initially having a cohort of approximately 20 Subjects to recruit. The study will enroll approximately 200 fixed bearing and approximately 200 rotating platform configurations.
The 2-year KOOS-ADL (activities of daily living) was selected as the primary endpoint because it will evaluate the post-operative period during which outcomes typically plateau and will therefore provide a good indication of longer term outcomes
Male and female Subjects, age 22-80 years, inclusive, who require a primary knee arthroplasty in a joint that, due to deformity, instability, bone loss etc., necessitates the use of implants found within the ATTUNE Revision knee system and are suitable candidates for TKA using the ATTUNE® Revision system are eligible for enrollment in this study.
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
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 consent, inclusive.
- •The decision to have knee replacement with the study device is regardless of the research.
- •The devices are to be used according to the approved indications.
- •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 PROMs in either English or one of the available translations.
- •Subject has not been diagnosed with an inflammatory arthritis (including gout, rheumatoid, psoriatic etc.)
排除标准
- •The Subject is a woman who is pregnant or lactating.
- •Contralateral knee has already been enrolled in this study. If the Investigator plans to treat a potential study subject with either simultaneous (two (2) knees in one (1) surgical setting) or staged bilateral TKA, then this subject may be enrolled; however, only the first knee may be enrolled into this study.
- •Subject had a contralateral amputation.
- •Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement) 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 his/her 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 activities (e.g., muscular dystrophy, multiple sclerosis, Charcot disease).
- •Subject has a medical condition with less than five (5) years life expectancy as determined by the Investigator.
- •Subject has been diagnosed with an inflammatory arthritis (including uncontrolled gout, rheumatoid, psoriatic etc.).
研究组 & 干预措施
ATTUNE Revision knee system
The ATTUNE Revision knees system is complementary to the ATTUNE primary knee portfolio and includes both rotating platform (RP) and fixed bearing (FB) configurations. The system includes a full compliment of implants designed to address the challenges faced in complex primary knee surgeries. These implants include Stemmable tibial and femoral components, augments, sleeves and offsets
干预措施: ATTUNE Revision Knee System in Total Knee Arthroplasty (Device)
结局指标
主要结局
KOOS ADL
时间窗: 2 Years
Evaluate change from preoperative baseline to the 2 yr timepoint in patient reported functional outcome, KOOS-ADL for the ATTUNE® Revision TKA FB and RP configurations.
次要结局
- Adverse Events(Intraoperative, 6 weeks, 1 yr., 2 yr., 3 yr., 4 yr., 5 yr.)
- American Knee Society Score(Baseline, 5 year)
- EQ-5D-5L(Baseline, 5 year)
- VAS Pain Score(Baseline, 5 year)
- Restoration of joint line(First post-operative radiograph (1 day))
- Knee Injury and Osteoarthritis Outcome Score - Activities of Daily Living (KOOS-ADL)(Baseline, 5 Year)
- Patient's Knee Implant Performance (PKIP)(Baseline, 5 Year)
- Readmissions(6 weeks, 1 yr., 2 yr., 3 yr., 4 yr., 5 yr.)
- Survivorship(1, 2, 3, 4 and 5 years)
- Anatomic Tibiofemoral Alignment(1, 2 and 5 years)
- Femoral component alignment(1, 2 and 5 years)
- American Knee Society Score (surgeon evaluation)(Baseline, 5 year)
- Frequency of radiolucent line occurrence(1, 2 and 5 years)
- Tibial component alignment(1, 2 and 5 years)
- American Knee Society Score(Baseline, 5 Year)