NCT02440672进行中（未招募）不适用
A Prospective, Non-randomized, Single Cohort, Multicenter Study to Evaluate the Clinical Outcomes of Total Knee Arthroplasty (TKA) Using the JOURNEY™ II CR Total Knee System
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 170
- 试验地点
- 17
- 主要终点
- Non-inferiority of the survival rate of the J II CR TKS with the reference survival rate of a literature reference at 5 and 10-years post-operatively
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of the JOURNEY™ II CR Total Knee System in subjects with degenerative joint disease (DJD) requiring primary total knee replacement.
详细描述
This is a prospective, non-randomized, single cohort, multicenter study to evaluate the clinical outcomes of TKA using the JOURNEY™ II CR Total Knee System in subjects with degenerative joint disease (DJD) requiring primary total knee replacement. One hundred and seventy (170) subjects will be enrolled at up to 18 clinical sites globally. Follow-up clinical assessments will be performed at 3 months, 1 year, 2 years, 5 years, and 10 years post-operatively.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 是
入选标准
- •Subjects MUST meet ALL of the following criteria for inclusion in the study:
- •Has signed the IRB/EC approved ICF specific to this study prior to study participation
- •Is a male or female ≥ 22 and ≤ 75 years of age presenting with degenerative joint disease (DJD) of the knee
- •Is a candidate for primary total knee arthroplasty with the JOURNEY™ II CR Total Knee System due to DJD, defined by one of the following:
- •Post-traumatic arthritis
- •Osteoarthritis
- •Degenerative arthritis
- •Is able to read and understand the approved Informed Consent Form and Patient Reported Outcome (PRO) assessments (written and oral)
- •Is in general good health (as determined by the Investigator) based on screening assessments and medical history
- •Is independent, ambulatory, and can comply with all post-operative evaluations
- •plans to be available through ten (10) years post-operative follow-up
排除标准
- •1. Subjects will be excluded from the study, if they meet ANY one (1) of the following criteria:
- •Any of the following conditions in the index joint:
- •does not require patella resurfacing
- •has received a TKA or unicondylar arthroplasty
- •has inadequate bone stock to support the device (e.g. severe osteopenia/osteoporosis)
- •Any of the following conditions in the contralateral joint:
- •has enrolled in the study for the contralateral knee
- •has received TKA as a revision for a failed total or unicondylar knee arthroplasty
- •has received a primary TKA or unicondylar knee arthroplasty that is not fully healed and well-functioning, as determined by Investigator
- •Any of the following conditions of the hip:
- •received contralateral or ipsilateral revision hip arthroplasty
- •has ipsilateral hip arthritis resulting in flexion contracture
- •has received a ipsilateral or contralateral primary total hip arthroplasty or hip resurfacing arthroplasty, that is not fully healed and well-functioning, as determined by Investigator
- •Has diagnosis of an immunosuppressive disorder
- •Has presence of malignant tumor, metastatic, or neoplastic disease
- •Has family history of severe osteoporosis/osteopenia
- •Has a known allergy to study device or one or more of its components
- •Has conditions that may interfere with the TKA survival or outcome (e.g. Paget's or Charcot's disease, vascular insufficiency, lupus, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease)
- •Is receiving medication for the diagnosis of fibromyalgia
- •has a lower extremity condition causing abnormal or restricted ambulation (e.g. ankle fusion, ankle arthroplasty, previous hip fracture)
- •Is pregnant or plans to become pregnant during the study
- •Has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study and complete PROs, as determined by Investigator
- •Has a BMI > 40
- •Is currently enrolled in or has participated in another investigational drug, biologic, or device study within 3 months of enrollment
- •Is currently involved in personal injury litigation or a worker's compensation claim
- •Is facing current or impending incarceration
- •Is known to be at risk for lost to follow-up, or failure to return for scheduled visits
研究组 & 干预措施
Device:JOURNEY™ II CR Total Knee System (J II CR TKS)
Subjects having TKA with JOURNEY™ II CR Total Knee System
干预措施: JOURNEY™ II CR Total Knee System (J II CR TKS) (Device)
结局指标
主要结局
Non-inferiority of the survival rate of the J II CR TKS with the reference survival rate of a literature reference at 5 and 10-years post-operatively
时间窗: Up to 10 year post-operative analysis
Equivalence in 1 year post-operative mean Range of Motion (ROM) in subjects receiving the J II CR TKS as compared to the literature reference mean ROM
时间窗: 1 year post-op analysis
次要结局
- Clinical Outcomes: Self-Administered Patient Satisfaction Scale for Primary Hip and Knee Arthroplasty (SAPSS(Pre-Op to 10 yrs)
- Safety Endpoints:Adverse events, to be evaluated by type, frequency, severity, and relatedness to the study treatment.(Pre-Op to 10 yrs)
- Safety Endpoints: Manipulations under anesthesia(Pre-Op to 10 yrs)
- Health Economic Endpoints: Unscheduled professional visits (e.g. hospital, emergency room, orthopedic clinic, primary care physician)(30, 60, and 90 days)
- Health Economic Endpoints: Discharge destination(s)/length of stay(30, 60, and 90 days)
- Health Economic Endpoints: Concomitant medications/procedures associated with the knee(30, 60, and 90 days)
- Clinical Outcomes: 2011 Knee Society Score (2011 KSS) clinical evaluation(Pre-Op to 10 yrs)
- Health Economic Endpoints : Physical therapy visit quantification/duration(30, 60, and 90-day hospital re-admission rate)
- Safety Endpoints: Radiographic analysis(Pre-Op to 10 yrs)
- Clinical Outcomes: EuroQol 5D (EQ-5D) scale(Pre-Op to 10 yrs)
研究者
研究点 (17)
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