Short, Medium and Long Term Survivorship of Attune Primary Knee Prosthesis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,542
- 试验地点
- 48
- 主要终点
- Survivorship of each configuration.
研究概览
简要总结
This post-marketing investigation will evaluate the long term (up to 15 years) survivorship of the Attune Primary Knee Prosthesis in patients with non-inflammatory degenerative joint disease. Data from Subjects who receive one of four knee configurations will be pooled to establish a contemporary dataset.
详细描述
Approximately 30 sites, worldwide, will recruit 1200 patients (1200 knees). Each study site is expected to enroll approximately 50 patients (50 knees). An additional 10 subjects per site may be recruited at sites which have Sub-Investigators participating in the study. Cohort reallocation is permitted. There is no control group. One thousand two hundred (1200) Subjects will be stratified into 4 subgroups of 300: cruciate retaining fixed bearing(CR FB), cruciate retaining rotating platform (CR RP), posterior stabilized fixed bearing (PS FB), and posterior stabilized rotating platform (PS RP).
Treatment assignment in this study is not randomized. Each site will only enroll patients in one of the four knee configuration sub-groups most commonly used as their standard of care.
This study allowed for enrolment into the study by two methods. The first method was by enroling subjects to receive the implant under study with the expectation to follow them out to 15 years. The second method was done to offset follow-up attrition. The second method allowed additional interested sites that had previously participated in a two-year follow-up study (NCT01746524) on this implant (subjects implanted and followed for two years) to reconsent interested subjects to be further followed out to 15 years in this study. The original 29 sites enroled 1232 subjects. Adding of the interested sites from the 2-yr follow-up study (NCT01746524) increased the sites from 29 to 37 sites. As of the last study update, the current enrolment is now1538.
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 75 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 75 years at the time of surgery, inclusive.
- •Subject was diagnosed with NIDJD.
- •Subject is a suitable candidate for cemented primary total knee arthroplasty using the devices described in this protocol with either resurfaced or non-resurfaced patellae.
- •Subject has given voluntary, written informed consent to participate in this clinical investigation and has authorized the transfer of his/her information to DePuy.
- •Subject is currently not bedridden.
- •Subject in the opinion of the Clinical Investigator, is able to understand this clinical investigation and is willing and able to perform all study procedure and follow-up visits and co-operate with investigational procedures.
- •Subject must be comfortable with speaking, reading and understanding questions and providing responses in an available translated language for the PROs in the protocol.
- •The devices specified in this protocol were implanted.
排除标准
- •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 (unilateral, bicompartmental or patellofemoral joint replacement), patellectomy, high tibial osteotomy or primary TKA in affected knee.
- •Subject is currently experiencing radicular pain from the spine.
- •Subject has participated in an IDE/IND clinical investigation with an investigational product in the last three months.
- •Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
- •Subject is a known drug or alcohol abuser or has a psychological disorder that could affect their ability to complete patient reported questionnaires.
- •Subject was diagnosed with fibromyalgia that is currently being treated with prescription medication.
- •Subject has significant neurological or musculoskeletal disorders 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 erythematosis, etc.).
- •Subject is not comfortable with speaking, reading, and understanding questions and providing responses in an available translated language for the PROs in the protocol.
- •Subject has a medical condition with less than 5 years of life expectancy.
研究组 & 干预措施
Attune Primary Total Knee Replacement
Subjects will receive one of the following Attune total knee implants:
Cruciate retaining fixed bearing (CR FB) Cruciate retaining rotating platform (CR RP) Posterior stabilized fixed bearing (PS FB) Posterior stabilized rotating platform (PS RP)
干预措施: Attune Primary Total Knee Replacement (Device)
结局指标
主要结局
Survivorship of each configuration.
时间窗: Minimum 15 years (5414 - 5658 days)
Kaplan-Meier survival analysis will be used to calculate the survivorship of all 4 configurations (CR FB, CR RP, PS FB, PS RP).
次要结局
- Survivorship(Minimum 10 years (3589 - 5413 days))
- Patient Reported Outcome: EuroQol 5D 3L questionnaire (EQ-5D-3L)(Pre-op (-90 to -1 days before surgery), <1 year (1 - 303 days), minimum 1 year (304 - 668 days), minimum 2 years (669 - 1763 days), minimum 5 years (1764 - 3588 days), minimum 10 years (3589 - 5413 days), minimum 15 years (5414 - 5658 days).)
- Evaluate the impact of surgeon learning curve on clinical and functional outcomes(<1 year (1 - 303 days), minimum 1 year (304 - 668 days), minimum 2 years (669 - 1763 days), minimum 5 years (1764 - 3588 days), minimum 10 years (3589 - 5413 days), minimum 15 years (5414 - 5658 days).)
- Implant fixation: Radiographic assessment of bone-implant interface performance(Minimum 15 years (5414 - 5658 days))
- Patient-reported Outcome: Oxford Knee Score(Pre-op (-90 to -1 days before surgery), <1 year (1 - 303 days), minimum 1 year (304 - 668 days), minimum 2 years (669 - 1763 days), minimum 5 years (1764 - 3588 days), minimum 10 years (3589 - 5413 days), minimum 15 years (5414 - 5658 days).)
- Patient-reported Outcome: Pre-surgical/Post-surgical Patient's Knee Implant Performance (PKIP)(Pre-op (-90 to -1 days before surgery), <1 year (1 - 303 days), minimum 1 year (304 - 668 days), minimum 2 years (669 - 1763 days), minimum 5 years (1764 - 3588 days), minimum 10 years (3589 - 5413 days), minimum 15 years (5414 - 5658 days).)
- Patient-reported Outcome: Knee Society Score(Pre-op (-90 to -1 days before surgery), <1 year (1 - 303 days), minimum 1 year (304 - 668 days), minimum 2 years (669 - 1763 days), minimum 5 years (1764 - 3588 days), minimum 10 years (3589 - 5413 days), minimum 15 years (5414 - 5658 days).)
- Patient-reported Outcome: Knee Injury and Osteoarthritis Outcome Score (KOOS)(Pre-op (-90 to -1 days before surgery), <1 year (1 - 303 days), minimum 1 year (304 - 668 days), minimum 2 years (669 - 1763 days), minimum 5 years (1764 - 3588 days), minimum 10 years (3589 - 5413 days), minimum 15 years (5414 - 5658 days).)
- Evaluate changes in femoral component and tibial component alignment(Pre-op (-90 to -1 days before surgery), <1 year (1 - 303 days), minimum 1 year (304 - 668 days), minimum 2 years (669 - 1763 days), minimum 5 years (1764 - 3588 days), minimum 10 years (3589 - 5413 days), minimum 15 years (5414 - 5658 days).)
- Type and Frequency of Adverse Events (AEs) for all enrolled subjects(Pre-op (-90 to -1 days before surgery), <1 year (1 - 303 days), minimum 1 year (304 - 668 days), minimum 2 years (669 - 1763 days), minimum 5 years (1764 - 3588 days), minimum 10 years (3589 - 5413 days), minimum 15 years (5414 - 5658 days).)
- Survivorship(Minimum 5 years (1764 - 3588 days))
- Implant fixation: Radiographic assessment of bone-implant interface performance(Minimum 1 year (304 - 668 days))
- Implant fixation: Radiographic assessment of bone-implant interface performance(Minimum 2 years (669 - 1763 days))
- Implant fixation: Radiographic assessment of bone-implant interface performance(Minimum 5 years (1764 - 3588 days))
- Implant fixation: Radiographic assessment of bone-implant interface performance(Minimum 10 years (3589 - 5413 days))