JPRN-UMIN000034044已完成未知
A Prospective, Multicenter, Study to Evaluate the Safety and Effectiveness of the JOURNEY II XR Total Knee System with VERILAST Technology - JOURNEY II XR with VERILAST in Japan
Smith & Nephew KK0 个研究点目标入组 106 人开始时间: 2018年11月1日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 106
研究概览
简要总结
Clinical success of the JOURNEY II XR Total Knee System met the primary objective as it is no worse than the 98% historical control with a margin of 7% (i.e. 91% non-inferiority limit), p=0.006.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 20years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1. have any of the following conditions in the index joint: a. Intra-articular corticosteroid therapy (or any other intra-articular therapy) in the study knee within 3 months of study enrollment b. Significant varus or valgus deformities (>15 angle) c. Incomplete or insufficient tissue surrounding the knee d. Collateral ligament insufficiency e. Inadequate bone stock to support the device (e.g., severe osteopenia/osteoporosis) or will require use of femoral and tibial stems f. History of prior TKA 2. have any of the following conditions in the contralateral joint: a. a previous TKA as a revision for a failed total or unicondylar knee arthroplasty b. a primary TKA or unicondylar knee arthroplasty that is not fully healed and well-functioning as determined by the Investigator 3. have any of the following conditions of the hip: a. a previous contralateral or ipsilateral revision hip arthroplasty b. ipsilateral hip arthritis resulting in flexion contracture c. previously received an ipsilateral or contralateral primary total hip arthroplasty or hip resurfacing arthroplasty that is not fully healed and well-functioning as determined by the Investigator 4. have a diagnosis of an immunosuppressive disorder 5. have an active infection, treated or untreated, systemic or at the site of the planned surgery 6. have conditions that may interfere with the TKA survival or outcome, including but not limited to: Paget's disease, Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, renal insufficiency or neuromuscular disease 7. have a BMI > 40 8. be facing current or impending incarceration 9. have a known allergy to study device or one or more of its components 10. have, in the opinion of the Investigator, an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, drug or alcohol abuse
研究者
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