NCT02204228终止不适用
A Post-market Clinical Follow-up Study of the TITAN™ Reverse Shoulder System Used in Primary or Revision Total Shoulder Arthroplasty
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 151
- 试验地点
- 17
- 主要终点
- Survival (lack of implant component removal or revision)
研究概览
简要总结
The Integra® TITAN™ Reverse Shoulder System (TRS) is a semi-constrained total shoulder construct. When used under the conditions and purposes intended the TRS will relieve pain and restore some functional joint motion to the affected shoulder. The purpose of this study is to assess the short, mid and long term outcomes of the TITAN™ Reverse 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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with grossly deficient rotator cuff with severe arthropathy or Subjects with failed joint replacement with grossly deficient rotator cuff
- •Subjects with a shoulder joint anatomically and structurally suited to receive the device
- •Subjects at least 21 years of age and skeletally mature at the time of surgery
- •Subject provided consent to participate in the clinical study (having signed the Informed Consent Form)
排除标准
- •Subjects without a functional deltoid muscle
- •Subjects with active local or systemic infection
- •Subjects with inadequate bone stock in the proximal humerus or glenoid fossa for supporting the components
- •Subjects with poor bone quality such as osteoporosis where there could be considerable migration of the prosthesis and/or a chance of fracture of the humerus or glenoid
- •Subjects with muscular, neurologic, or vascular deficiencies that compromise the affected extremity
- •Subjects with known metal allergies
- •Subjects are known to be at risk for lost to follow-up, or failure to return for scheduled visits
- •Subjects who are prisoners
- •Female subject who are pregnant, nursing, or of childbearing potential while not practicing effective contraceptive methods
研究组 & 干预措施
TITAN™ Reverse Shoulder System (TRS)
TITAN™ Reverse Shoulder System (TRS) is a semi-constrained total shoulder construct.
干预措施: TITAN™ Reverse Shoulder System (TRS) (Device)
结局指标
主要结局
Survival (lack of implant component removal or revision)
时间窗: 2 Year
Any implant revisions or device related adverse events must be reported as soon as the event is discovered. Assessment of adverse events will occur at each clinic visit.
次要结局
- Efficacy assessed by comparing clinical results after surgery as measured with American Shoulder and Elbow Surgeons Score (ASES)(2 Year/5 Year/ 7Year/ 10 Year)
- Efficacy assessed by comparing clinical results after surgery as measured with EuroQOL-5 Dimension (EQ-5D) score(2 Year/5 Year/ 7Year/ 10 Year)
- Efficacy assessed by comparing clinical results after surgery as measured with Constant score.(2 Year/5 Year/ 7Year/ 10 Year)
- Efficacy assessed by comparing clinical results after surgery as measured with Range of motion (ROM)(2 Year/5 Year/ 7Year/ 10 Year)
- Lack of unanticipated device related serious adverse events.(2 Year/5 Year/ 7Year/ 10 Year)
- Survival (lack of implant component removal or revision)(5 Year/7 Year/10 Year)
- Efficacy assessed by comparing clinical results after surgery as measured with Pain Visual Analog Scale (VAS).(2 Year/5 Year/ 7Year/ 10 Year)
- Efficacy assessed by comparing clinical results after surgery as measured with Radiographs(2 Year/5 Year/ 7Year/ 10 Year)
- Efficacy assessed by comparing clinical results after surgery as measured with SANE (Single Assessment Numeric Evaluation)(2 Year/5 Year/ 7Year/ 10 Year)
研究者
研究点 (17)
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