NCT05002335进行中（未招募）不适用
Clinical and Radiological Outcomes of Medacta Shoulder System (BE)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Survival rate
研究概览
简要总结
This is a post-market surveillance study on Medacta Shoulder System
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18 years
- •Patient with one of the following diagnosis:
- •Primary osteoarthritis
- •Secondary osteoarthritis
- •Cuff tear arthropathy; insufficient rotator cuff
- •Acute fracture (<21d)
- •Rheumatoid or inflammatory arthritis
- •Avascular necrosis
- •Other posttraumatic condition
- •Revision of shoulder arthroplasty
排除标准
- •Patients with malignant diseases (at the time of surgery)
- •Patients with proven or suspect infections (at the time of surgery)
- •Patients with functional deficits other than dysfunction of the shoulder (at the time of surgery)
- •Patients with known incompatibility or allergy to products materials (at the time of surgery)
结局指标
主要结局
Survival rate
时间窗: 5 years
Kaplan Meier method
次要结局
- Radiographic performance of the implants: Presence of radiolucencies(3 months, 1, 2, and 5 years)
- Number of Intraoperative and postoperative Adverse events(intraop, 3 months, 1, 2, and 5 years)
- Clinical outcome; Constant and Murley score(1, 2, and 5 years)
- Functional outcome: Oxford Shoulder Score(1, 2, and 5 years)
- Quality of life assesed by EQ-5D-5L score(1, 2, and 5 years)
研究者
研究点 (3)
Loading locations...
相似试验
进行中（未招募）
不适用
Clinical and Radiological Outcomes of Medacta Shoulder SystemPrimary OsteoarthritisSecondary OsteoarthritisRotator Cuff Tear ArthropathyRheumatoid Arthritis ShoulderAvascular NecrosisRevision of Shoulder ArthroplastyFractureNCT03547947Medacta International SA200
招募中
不适用
Clinical and Radiological Outcomes of Medacta Shoulder System FRPrimary OsteoarthritisSecondary OsteoarthritisRotator Cuff Tear ArthropathyRheumatoid Arthritis ShoulderRevision of Shoulder ArthroplastyFractureAvascular NecrosisNCT05926622Medacta International SA200
进行中（未招募）
不适用
Open-label, Prospective, Multicenter, Post-market Study to Evaluate the Reverse Medacta Shoulder System of Total Shoulder Prosthesis.Shoulder ProsthesisNCT04431973University Hospital, Tours100
招募中
不适用
Mirror Medacta Shoulder System Pivotal TrialArthritis ShoulderPost-traumatic Arthrosis of Other Joints, Upper ArmNCT05062252Medacta International SA100
已完成
不适用
Anatomical Shoulder™ Fracture PMCF StudyFractureNCT02465398Zimmer Biomet52