Multi-Center Clinical Investigation of the ATTUNE® Cementless Fixed Bearing Tibial Base and Cementless Patella Implants in Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 80
- 试验地点
- 30
- 主要终点
- One Year Functional Responder Rate of First 225 Subjects
研究概览
简要总结
This is a prospective, multi-center, non-randomized, single arm observational study. The primary objective of this clinical investigation is to evaluate functional responder rates with an objective performance criteria (OPC) of 85% as measured by the KOOS questionnaire for the first 225 tibia (CR FB and PS FB combined) implanted with the ATTUNE Cementless FB tray (primary and revision procedures) and will be analyzed when these patients have passed the 1 year preferred post-op window.
详细描述
The primary objective of this clinical investigation is to evaluate functional responder rates with an objective performance criteria (OPC) of 85% as measured by the KOOS questionnaire for the first 225 tibia (CR FB and PS FB combined) implanted with the ATTUNE Cementless FB tray (primary and revision procedures) and will be analyzed when these patients have passed the 1 year preferred post-op window. Study success will be determined using the primary TKA (CR FB and PS FB combined) analysis group.
The secondary objectives of this study are to establish the surgical effectiveness of the ATTUNE Cementless Tibial Base by evaluating type and frequency of Adverse Events and Device Deficiencies, functional responder rates with an objective performance criteria (OPC) of 85% as measured by the KOOS questionnaire for all subjects (CR FB and PS FB combined) at the 1-year timepoint, the change from preoperative baseline to the 6-week, 6-month, 1-year, 2-year and 5-year timepoints in functional outcomes and quality of life assessments, as measured using additional patient reported outcomes measures (PROMS), implant survivorship of the ATTUNE Cementless FB Tibial base using Kaplan-Meier survival analysis at 1, 2 and 5-year timepoints, and investigator-conducted radiographic analysis of the tibial and patellar components at 6 weeks/6 months 1, 2 and 5 years after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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 has a severely painful knee and/or impaired knee function resulting from osteoarthritis, post-traumatic arthritis, or a failed previous implant provided that adequate bone is present.
- •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.
排除标准
- •a) The Subject is a woman who is pregnant or lactating. b) Contralateral knee has already been enrolled in this study . c) Revision knee that was previously enrolled in the study as a primary knee (ipsilateral).
- •d) Subject has participated in a clinical study with an investigational product (drug or device) in the last two (2) years.
- •e) Subject has had surgery on their contralateral knee within six (6) months of study enrolment or has surgery planned on their contralateral knee less than six (6) months of the study surgery.
- •f) Subject is suffering from inflammatory arthritis in any joint (e.g., rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, etc.).
- •g) Active local or systemic infection. h) Loss of bone or musculature, inadequate bone quality (e.g. severe osteoporosis), neuromuscular compromise or vascular deficiency at the bone site in the affected limb in sufficient degree to render the procedure unjustifiable (e.g. absence of musculoligamentous supporting structures that could lead to implant instability, joint neuropathy).
- •i) Severe instability secondary to advanced loss of osteochondral structure or the absence of collateral ligament integrity.
- •j) The inability to make bone cuts (e.g. inadequate bone stock) so as to assure correct component position, a firm press fit, and intimate apposition of the cut bone and prosthetic surfaces.
- •k) Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
- •l) Subject, in the opinion of the Investigator, is a drug or alcohol abuser (in the last five 5 years) or has a psychological disorder that could affect their ability to complete patient reported questionnaires or be compliant with follow-up requirements.
结局指标
主要结局
One Year Functional Responder Rate of First 225 Subjects
时间窗: through study completion, up to 10 months
Functional Responder Rate with an Objective Performance Criteria of 85% as measured by the KOOS questionnaire for the first 225 tibia
次要结局
- Measure of Knees With Adverse Events(Through study completion, up to 10 months)
- Mean Number of Adverse Events Per Knee for Knees With Reported AEs(Through study completion, up to 10 months)
- Measure of Knees With Device Deficiencies(Through study completion, up to 10 months)
- Mean Number of Device Deficiencies Per Knee(Through study completion, up to 10 months)
- One Year Functional Responder Rate All Subjects(Through study completion, up to 10 months.)
- One Year Kaplan-Meier Implant Survivorship(Through study completion, up to 10 months)
- Two Year Kaplan-Meier Implant Survivorship(Through study completion, up to 10 months)
- Five Year Kaplan-Meier Implant Survivorship(Through study completion, up to 10 months)
- 6 Week Knee Society Score(Through study completion, up to 6 weeks)
- 6 Month Knee Society Score(Through study completion, up to 6 Months)
- One Year Knee Society Score(Through study completion, up to 10 months)
- Two Year Knee Society Score(Through study completion, up to 10 months)
- Five Year Knee Society Score(Through study completion, up to 10 months)
- Six Week Knee Injury and Osteoarthritis Outcome Score (KOOS)(Through study completion, up to 6 weeks)
- Six Month Knee Injury and Osteoarthritis Outcome Score (KOOS)(Through study completion, up to 6 Months)
- One Year Knee Injury and Osteoarthritis Outcome Score (KOOS)(Through study completion, up to 10 months)
- Two Year Knee Injury and Osteoarthritis Outcome Score (KOOS)(Through study completion, up to 10 months)
- Five Year Knee Injury and Osteoarthritis Outcome Score (KOOS)(Through study completion, up to 10 months)
- Six Week Forgotten Joint Score (FJS-12)(Through study completion, up to 6 weeks)
- Six Month Forgotten Joint Score (FJS-12)(Through study completion, up to 6 months)
- 1 Year Forgotten Joint Score (FJS-12)(Through study completion, up to 10 months)
- Two Year Forgotten Joint Score (FJS-12)(Through study completion, up to 10 months)
- Five Year Forgotten Joint Score (FJS-12)(Through study completion, up to 10 months)
- Six Week EuroQol 5-Dimension 5-Level (EQ-5D-5L)(Through study completion, up to 6 weeks)
- Six Month EuroQol 5-Dimension 5-Level (EQ-5D-5L)(Through study completion, up to 6 months)
- One Year EuroQol 5-Dimension 5-Level (EQ-5D-5L)(Through study completion, up to 10 months)
- Two Year EuroQol 5-Dimension 5-Level (EQ-5D-5L)(Through study completion, up to 10 months)
- Five Year EuroQol 5-Dimension 5-Level (EQ-5D-5L)(Through study completion, up to 10 months)
- Six Month Investigator-conducted Radiographic Analysis(Through study completion, up to 6 Months)
- One Year Investigator-conducted Radiographic Analysis(Through study completion, up to 10 months)
- Two Year Investigator-conducted Radiographic Analysis(Through study completion, up to 10 months)
- Five Year Investigator-conducted Radiographic Analysis(Through study completion, up to 10 months)