A Post-Market Clinical Evaluation of the ReUnion Reverse Shoulder Arthroplasty (RSA) System
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 102
- 试验地点
- 3
- 主要终点
- American Shoulder and Elbow Surgeons (ASES) Shoulder Score
研究概览
简要总结
This investigation is a prospective, multicenter clinical investigation. It is anticipated that a total of eighty (80) subjects will be enrolled at approximately 4-7 sites. The clinical investigation has been designed to follow the surgeon's standard of care for joint arthroplasty subjects, which entails clinical evaluation on a regular ongoing basis, or as needed should the subject become symptomatic in the treated joint.
详细描述
The objective of this clinical investigation is to demonstrate the safety and efficacy/performance of the ReUnion RSA System. Efficacy/performance of the procedure will be measured the American Shoulder and Elbow Surgeons (ASES) Shoulder Score. Safety of the ReUnion RSA System will be demonstrated through reporting of device-related intra-operative and post-operative Adverse Events (AEs). Enrolled subjects will be assessed at Pre-Operative, Operative/Discharge, and at 6 Weeks, 6 Months, 12 Months, 24 Months and annually thereafter up to 10 years following the index procedure.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is willing to sign the informed consent.
- •Subject is willing and able to comply with postoperative scheduled clinical and radiographic evaluations.
- •Subject is male or non-pregnant female and 18 years or older at the time of surgery.
- •Subject's joint has gross rotator cuff deficiency, a functional deltoid muscle and is anatomically and structurally suited to receive the implant and subject has one or more of the following:
- •Painful, disabling joint disease of the shoulder resulting from degenerative arthritis or rheumatoid arthritis
- •Failed previous shoulder joint replacement
排除标准
- •Subject has an active or suspected latent infection in or about the shoulder joint.
- •Subject has mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure or complications in postoperative care.
- •Subject has bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and/or fixation to the prosthesis.
- •Subject has anticipated activities which would impose high stresses on the prosthesis and its fixation.
- •Subject is obese such that he/she produces a load on the prosthesis which can lead to failure of fixation of the device or to failure of the device itself.
- •Subject has concomitant disease(s) which may significantly affect the clinical outcome.
- •Subject has traumatic or pathologic fracture of the proximal humerus
结局指标
主要结局
American Shoulder and Elbow Surgeons (ASES) Shoulder Score
时间窗: 24 Months
This is a mixed outcome reporting measure, applicable for use in patients with shoulder pathology regardless of diagnosis and consists of a pain visual analog scale (VAS) and 10 functional questions. The primary endpoint of the clinical investigation is to demonstrate non-inferiority of the device to the selected literature controls, as measured by the ASES Shoulder Score at 24 Months post-operative. Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition.
次要结局
- Safety Will be Measured by Capturing the Incidence Rate of Device-related Intra-operative Adverse Events.(24 months)
- Safety Will be Measured by Capturing the Incidence Rate of Device-related Post-operative Adverse Events.(24 months)
- Efficacy Will be Measured by Monitoring All Implant Survivorship in All Subjects Who Have the Reverse Total Shoulder Endoprosthesis With the ReUnion RSA System.(24 months)