NCT03768128已完成不适用
A Prospective, Multicenter Post-Market Clinical Follow-up Study to Evaluate the Safety and Performance of the Journey™ II UNI Unicompartmental Knee System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 154
- 试验地点
- 6
- 主要终点
- Implant survival 5 years postoperatively
研究概览
简要总结
This clinical study will evaluate the early to midterm safety and performance of the JOURNEY™ II UNI UKS in patients with non-inflammatory degenerative joint disease of the knee requiring lateral or medial knee compartment replacement. Clinical, radiographic, health economic and safety outcomes will be evaluated.
详细描述
To assess the safety and performance of the JOURNEY™ II UNI UKS in patients with unicompartmental degeneration of the knee by demonstrating non-inferiority of the cumulative percent implant survival in subjects with the JOURNEY™ II UNI UKS implanted, compared to a literature reference rate of 91.7% (AOA annual report 2015)12 at 5 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must meet all of the following criteria for inclusion in the study.
- •Unicompartmental, NIDJD, including OA, traumatic arthritis, or avascular necrosis.
- •Eighteen (18) years of age or older at the time of surgery.
- •Skeletally mature in the judgement of the PI.
- •Has met an acceptable preoperative medical clearance and is free of (or acceptably managed) cardiac, pulmonary, hematological, infection, or other conditions that would pose an excessive operative risk.
- •Willing and able to participate in required follow-up visits at the investigational site and to complete study procedures and questionnaires.
- •Consented to participate in the study by signing the EC-approved ICF.
排除标准
- •Subjects meeting any of the following criteria must be excluded from participation in the study.
- •Correction of functional deformity.
- •Revision procedures where other treatments or devices have failed.
- •Treatment of fractures that are unmanageable using other techniques.
- •Inadequate bone stock to support the device which would make the procedure unjustifiable, including but not limited to severe osteopenia/osteoporosis or family history of severe osteoporosis/osteopenia.
- •Body Mass Index (BMI) >
- •Collateral ligament insufficiency.
- •Active infection, treated or untreated, systemic or at the site of the planned surgery or previous intra-articular infections.
- •Incomplete or deficient soft tissue surrounding the knee.
- •Conditions that may interfere with the UKA survival or outcome, including but not limited to Paget's disease, Charcot disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, renal insufficiency or neuromuscular disease.
- •Diagnosis of an immunosuppressive disorder.
- •Known allergy to study device or one or more of its components.
- •Pregnant or planning to become pregnant during the course of the study.
- •Subject, in the opinion of the PI, has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation
结局指标
主要结局
Implant survival 5 years postoperatively
时间窗: 5 years
次要结局
- Device-related adverse events(5 year)
- Radiographic assessments(5 year)
研究者
研究点 (6)
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