A Post-Market Clinical Evaluation of the ReUnion Reversible Fracture (RFX) System
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 10
- 试验地点
- 3
- 主要终点
- 24-month Mean ASES Shoulder Score: Arm B (Reverse Shoulder Arthroplasty)
研究概览
简要总结
This investigation is a prospective, multi-center clinical investigation. It is anticipated that a total of one hundred (100) subjects will be enrolled at approximately 5-10 sites. The clinical investigation has been designed to follow the surgeon's standard of care for joint arthroplasty patients, which entails clinical evaluation on a regular ongoing basis, or as needed should the patient 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 RFX System. Efficacy/performance of the procedure will be measured by the American Shoulder and Elbow Surgeons (ASES) Shoulder Score. Safety of the ReUnion RFX System will be demonstrated through reporting of device-related intraoperative and postoperative 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 evaluations.
- •Subject is male or non-pregnant female and 18 years or older at the time of surgery.
- •When used with ReUnion Total Shoulder Arthroplasty (TSA)Humeral & Glenoid components as a Hemiarthroplasty or Total Shoulder Replacement, subject has one or more of the following:
- •Aseptic necrosis of humeral head;
- •Painful, disabling joint disease of the shoulder resulting from degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis;
- •Proximal humeral fracture and/or dislocation;
- •Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results;
- •Previous unsuccessful total shoulder replacement, resurfacing or other procedure
- •When used with ReUnion RSA Humeral & Glenoid Components as a primary, fracture or revision total shoulder replacement, 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;
- •Proximal humeral fracture
- •Previously failed 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 severe concomitant disease(s)which may significantly affect the clinical outcome.
- •For Total Shoulder Arthroplasty and Hemiarthroplasty: Subject has absent, irreparable or non-functioning rotator cuff and other essential muscles
结局指标
主要结局
24-month Mean ASES Shoulder Score: Arm B (Reverse Shoulder Arthroplasty)
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.
12-month Mean ASES Shoulder Score: Arm B (Reverse Shoulder Arthroplasty)
时间窗: *12 months (reporting 12mth as more data available)
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
- Device-related Adverse Events(24 mths)
- Implant Survivorship(10 years)