Prospective Post Market Clinical Follow-up Study of the Zimmer Trabecular Metal Reverse Should System Used in Primary or Revision Reverse Total Shoulder Arthroplasty
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
- 9
- 主要终点
- Survivorship
研究概览
简要总结
The objectives of this study are to obtain survival and outcome data on the Trabecular Metal Reverse Shoulder System when used in primary or revision reverse total shoulder arthroplasty.
详细描述
The objectives of this study are to obtain survival and outcome data on the Trabecular Metal Reverse Shoulder System when used in primary or revision reverse total shoulder arthroplasty. This will be done by analysis of standard scoring systems, radiographs and adverse event records. Data will be collected and analyzed to monitor pain, function, and survivorship and to confirm the performance of the Trabecular Metal Reverse Shoulder System.
Performance will be evaluated by monitoring the frequency and incidence of adverse events as well as by assessment of the overall pain and functional performances, survivorship, health status and radiographic parameters of all enrolled study subjects who receive the Trabecular metal Reverse Shoulder System.
Pain and functional performance will be measured using the American Shoulder and Elbow Surgeons (ASES) Shoulder Assessment and the Single Assessment Numeric Evaluation (SANE), survivorship will be based on removal or intended removal of the device, health status will be determined by evaluation of the Short Form Survey12 (SF-12) as well as Adverse Events (AEs) and radiographic parameters analysis of x-rays.
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
- •Patient is > 18 years of age;
- •Patient is skeletally mature;
- •Patient qualifies for primary or revision unilateral or bilateral reverse total shoulder arthroplasty based on physical exam and medical history including the following: osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, ununited humeral head fracture, irreducible 3-and 4-part proximal humeral fractures, avascular necrosis, gross rotator cuff deficiency or failed total shoulder arthroplasty (both glenoid and humeral components require revision);
- •Patient is willing and able to provide written informed consent;
- •Patient is willing and able to cooperate in the required post-operative therapy;
- •Patient is willing and able to complete scheduled follow-up evaluations/questionnaires as described in the Informed Consent;
- •Patient has participated in the Informed Consent process and has signed the Institutional Review Board (IRB)/Ethical Review Board (ERB) approved informed consent.
排除标准
- •The patient is a prisoner;
- •The patient is mentally incompetent or unable to understand what participation in the study entails;
- •The patient is a known alcohol or drug abuser;
- •The patient is anticipated to be non-compliant;
- •The patient has one of the following compromising the affected limb: a significant injury to the upper brachial plexus, paralysis of the axillary nerve or a neuromuscular disease compromising the affected limb which would render the procedure unjustifiable;
- •The patient has a local/systemic infection;
- •The patient is known to be pregnant;
- •The patient has marked bone loss;
- •The patient has a known sensitivity or allergic reaction to one or more of the implanted materials;
- •The patient is unwilling or unable to give consent or to comply with the follow-up program.
研究组 & 干预措施
Trabecular Metal Reverse Shoulder System
Patients requiring primary or revision reverse total shoulder arthroplasty who receive the Trabecular Metal Reverse Shoulder System
干预措施: Trabecular Metal Reverse Shoulder System (Device)
结局指标
主要结局
Survivorship
时间窗: 10 Years
Based on removal or intended removal of the device and determined using the Kaplan-Meier method.
次要结局
- Pain and Functional Performance(10 Years)