Multi-Center Clinical Evaluation of the ATTUNE® Revision System in Revision 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
- 63
- 主要终点
- Survivorship
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 revision total knee arthroplasty.
详细描述
The study is designed as a non-comparative, worldwide, multi-center study with up to 30 sites that will intend to implant a total of 400 Subjects (200 PS RP and 200 PS FB) with the study devices. The follow-up period of 5 years was selected to cover both the early post-operative period as well as the medium term period which is a good indicator of longer term survivorship.
The primary endpoint of survivorship at 5 years was selected to capture the time period during which the majority of revision failures occur while providing a good indication of long term survivorship. The secondary outcomes include commonly used measures of clinical performance that will allow for comparison with published literature. Additionally, patient reported outcomes, AORI bone defect classification , satisfaction and pain scores will be collected and analyzed.
Male and female Subjects, age 22-80 years, inclusive, with a failed primary knee arthroplasty, including unicompartmental or failed previous revision TKA, who are suitable candidates for revision TKA using the ATTUNE® Revision system are eligible for enrollment in this study. The use of the ATTUNE Revision system includes both partial and complete revision surgical procedures, including implantation of revision components as the second stage within a two-stage treatment for infection.
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.
- •Subject presents with a primary knee arthroplasty (primary TKA, unicompartmental) or prior revision TKA that requires a revision procedure of implanted tibial and/or femoral components.
- •The decision to perform a knee revision with the study device is regardless of the research.
- •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
- •The devices are to be used according to the approved indications.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.
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.
- •Subject is currently diagnosed with radicular pain from the spine that radiates into the limb to receive RTKA.
- •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.
- •Uncontrolled gout
研究组 & 干预措施
ATTUNE Revision Knee System
The ATTUNE Revision 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 revision knee surgeries. These implants include Stemmable tibial and femoral components, augments, sleeves and offsets
干预措施: ATTUNE Revision Knee System in Revision Total Knee Arthroplasty (Device)
结局指标
主要结局
Survivorship
时间窗: 5 Years
To evaluate the 5 year survivorship using Kaplan-Meier survival analysis, with revision for any reason as the endpoint, for the ATTUNE® Revision TKA PS FB and PS RP configurations.
次要结局
- Tibial component alignment(1, 2 and 5 years)
- Patient's Knee Implant Performance (PKIP)(Baseline, 2 and 5 yr timepoints)
- American Knee Society Score(Baseline, 2 year, 5 year)
- Survivorship(1, 2, 3 and 4 years)
- Frequency of radiolucent line occurrence(1, 2 and 5 years)
- Restoration of joint line(First post-operative radiograph (1 day))
- Adverse Events(Intraoperative, 6 weeks, 1 yr, 2 yrs., 3 yrs., 4 yrs., 5 yrs.)
- Anatomic Tibiofemoral Alignment(1, 2 and 5 years)
- EQ-5D-5L(Baseline, 2 year and 5 year)
- VAS Pain Score(Baseline, 2 year and 5 year)
- Knee Injury and Osteoarthritis Outcome Score Short form (KOOS-PS)(Baseline, 2 year and 5 Year)
- Patient Satisfaction(Baseline, 2 year and 5 year)
- Readmissions(6 weeks, 1 yr, 2 yrs., 3 yrs., 4 yrs., 5 yrs)
- femoral component alignment(1, 2 and 5 years)