NL-OMON55575已完成不适用
A Prospective, Non-randomized, Consecutive Series, Multicenter, Post-Market Study to Evaluate the Clinical Outcome of Total Knee Arthroplasty Using Journey II BCS Total Knee System - Observational study of the Journey II BCS Total Knee System
Smith & Nephew Orthopaedics AG0 个研究点目标入组 33 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •subject requires primary total knee arthroplasty with the Journey II BCS
- •Total Knee System, including patella resurfacing
- •subject requires primary total knee arthroplasty due to degenerative joint
- •disease (primary osteoarthritis, post-traumatic arthritis, avascular necrosis,
- •rheumatoid arthritis)
- •subject is of legal age to consent (>18y), agrees to consent to and to follow
- •the study visit schedule (as defined in the study protocol and informed consent
- •form), by signing the EC approved informed consent form
排除标准
- •- age > 75 years
- •- subjects with immunosuppressive disorders
- •- subject has severe pronation of the ipsilateral foot or any other relevant
- •clinical condition contributing to abnormal ambulation (including but not
- •limited to ankle fusion, ankle arthroplasty, previous hip fracture, ipsilateral
- •hip arthritis resulting in flexion contracture)
- •- patient has undergone a previous major surgery to the study knee (including
- •but not limited to osteotomy, fracture fix, medial or lateral ligament surgery)
- •- subject has active infection or sepsis (treated or untreated)
- •- At the time of enrollment, subject has one or more arthroplasties that are
- •not fully healed and well-functioning, as determined by the investigator
- •- subject has presence of malignant tumor, metastatic, or neoplastic disease
- •- subject has conditions that may interfere with the TKA survival or outcome
- •- subject has inadequate bone stock to support the device (severe osteopenia,
- •family history of severe osteoporosis or osteopenia)
- •- subject has an emotional or neurological condition that would pre-empt their
- •ability or willingness to participate in the study
- •- subject has a BMI>40
研究者
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