Safety, Function and Quality of Life in Patient With Rotator Cuff Tear Arthropathy Treated With the Univers® Revers Shoulder Prosthesis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 166
- 试验地点
- 2
- 主要终点
- SADE within 2 years po
研究概览
简要总结
The primary safety objective is to demonstrate that severe device-related complication (Serious Adverse Device Effect = SADE) occur within 2 years after prosthesis implantation at a rate of less than 2%. Such adverse events include (but are not limited to) revisions due to dislocation or glenoid loosening, septic arthritis and scapular fractures requiring surgical repair.
详细描述
Reverse shoulder arthroplasty and its principles are still recognized today as the gold standard for treatment of degenerative arthropathy of the shoulder associated with an irreparable tear of the rotator cuff. The new Arthrex Univers® Revers Shoulder Prosthesis shows a large and narrow range of components, whether it is a stem, cup, spacer, inlay or glenosphere. Adjustment can be done in very small steps to match anatomic and biomechanic needs. The Arthrex Univers Revers Shoulder Prosthesis is the only device up to date that can be configured in two different inclination angles without any limitation in component use.
This multicentre case-series has the goal to evaluate whether patients with rotator cuff tear arthropathy benefit from the Univers® Revers shoulder prosthesis in terms of low complication risk, as well as high function and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patient aged 18 years and over
- •Patient with primary omarthrosis or secondary osteoarthritis associated with insufficiency in the centering function of the rotator cuff
- •Willing and able to give written informed consent to participate in the study including all follow-up examinations
排除标准
- •Previous ipsilateral shoulder arthroplasty
- •Acute shoulder trauma
- •Post-traumatic secondary osteoarthritis
- •Rheumatoid arthritis
- •General medical contraindication to surgery
- •Known hypersensitivity to the materials used
- •Tumour / malignoma
- •Any disease process that would preclude accurate evaluation (e.g. neuromuscular, psychiatric or metabolic disorder)
- •Bacterial infection at the time point of operation
- •Recent history of substance abuse
- •Legal incompetence
- •Pregnancy or
- •Participation in any other medical device or medicinal product study within the previous months that could influence the results of the present study
结局指标
主要结局
SADE within 2 years po
时间窗: 2 years po
The primary safety objective is to demonstrate that severe device-related complication (Serious Adverse Device Effect = SADE) occur within 2 years after prosthesis implantation at a rate of less than 2%.
次要结局
- Prosthesis survival at 2, 5 and 10 years(2, 5 and 10 years)
- Constant (Murley) score (CS)(6mo, 1, 2, 5 and 10 years)
- The Shoulder Pain and Disability Index (SPADI)(6mo, 1, 2, 5 and 10 years)
- Risk of adverse events intra-operatively, and post-operatively up to 2 years follow-up(2 years)
- Short version of the Disability of the Arm, Shoulder and Hand questionnaire (QuickDASH)(6mo, 1, 2, 5 and 10 years)
- EuroQoL EQ-5D-5L(6wk, 6mo, 1, 2, 5 and 10 years)
- Patient satisfaction(6wk, 6mo, 1, 2, 5 and 10 years)
- Radiographic Parameters(6mo, 1, 2, 5 and 10 years)
- Patient active and passive range of motion (ROM) and shoulder strength(6mo, 1, 2, 5 and 10 years)