NCT01705067已完成不适用
A Retro-Prospective, Non-randomized, Consecutive Series, SIngle Cohort, Multicenter Adaptive Design Study to Evaluate the Outcomes of Total Knee Arthroplasty (TKA) Using JOURNEY™ II BCS TotaL Knee SystEm (The NIMBLE Study)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 209
- 试验地点
- 12
- 主要终点
- Rate of ITB Friction Pain
研究概览
简要总结
Assess the safety and efficacy of the JOURNEY II BCS Total Knee System in subjects with degenerative knee disease requiring primary total knee replacement.
详细描述
Assess the safety and efficacy of the JOURNEY II BCS Total Knee System in subjects with degenerative knee disease requiring primary total knee replacement. Pre-operative and operative assessments collected retrospectively. All postoperative assessments beginning at the 6 month post-operative time point collected prospectively.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject received primary total knee arthroplasty with the JOURNEY™ II BCS Total Knee System due to degenerative joint disease
- •Subject is willing to sign and date an IRB approved consent form
- •Subject is of legal age to consent
- •Subject plans to be available through ten (10) years postoperative follow-up
- •Subject agrees to follow the study protocol
排除标准
- •Subject received the JOURNEY™ II BCS Total Knee System on the affected knee as a revision for a previously failed total or unicondylar knee arthroplasty
- •Subject received TKA on the contralateral knee as a revision for a previously failed total or unicondylar knee arthroplasty
- •Subject possesses a contralateral or ipsilateral revision hip arthroplasty
- •Subject has ipsilateral hip arthritis resulting in flexion contracture
- •At the time of enrollment, subject has one or more of the following arthroplasties that are not fully healed and well-functioning, as determined by the investigator:
- •Ipsilateral or contralateral primary total hip arthroplasty or hip resurfacing arthroplasty
- •Contralateral primary total knee or unicondylar knee arthroplasty
- •At the time of surgery, subject had an active infection or sepsis (treated or untreated)
- •At the time of surgery, subject had presence of malignant tumor, metastatic, or neoplastic disease
- •At the time of surgery, subject had conditions that may interfere with the TKA survival or outcome (i.e., Paget's or Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease)
- •At the time of surgery, subject had contralateral lower extremity condition causing abnormal ambulation
- •Subject is pregnant or plans to become pregnant during the study
- •Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
- •At the time of surgery, subject had a BMI>40
- •At the time of enrollment, subject has a BMI>40
- •Subject is enrolled in another investigational drug, biologic, or device study
- •Subject is facing current or impending incarceration
结局指标
主要结局
Rate of ITB Friction Pain
时间窗: 6 months post-operatively
次要结局
- Radiographic Evaluation(Baseline and 6 months post-operatively, 1 year post-operatively, 2 years post-operatively, 5 years post-operatively, and 10 years post-operatively)
- Adverse Events(6 months post-operatively, 1 year post-operatively, 2 years post-operatively, 5 years post-operatively, and 10 years post-operatively)
- Knee Society Score(6 months post-operatively, 1 year post-operatively, 2 years post-operatively, 5 years post-operatively, and 10 years post-operatively)
研究者
研究点 (12)
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