Retrospective and Prospective, Multi Centre Study on T.E.S.S® V2 Shoulder System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Constant Shoulder Score
研究概览
简要总结
This study is a Post Market Clinical Follow-up study to fulfill the post market surveillance requirements. The data collected from this study will serve the purpose of confirming safety and performance of the TESS Shoulder System.
详细描述
The objective of this retrospective and prospective, multicenter, non-controlled Post Market Clinical Follow-up study is to evaluate the mid-term (5-year) clinical performance of the TESS Version 2 Anatomic and Reverse prostheses in shoulder arthroplasty. The primary outcome is defined as the clinical performance determined using Constant Score. The secondary outcomes are the passive and active mobility, the radiographic evaluation, the complications (including dislocation and revisions/removals) and survivorship.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Except in special cases, the "anatomic" type is indicated for:
- •Centered osteoarthritis of the shoulder
- •Humeral head fractures
- •Rheumatoid arthritis (with intact rotator cuff)
- •Avascular necrosis of the humeral head
- •Except in special cases, the "reversed" type is indicated for:
- •Offset osteoarthritis of the shoulder
- •Massive and non-repairable rotator cuff tears
- •Rheumatoid arthritis (with degenerative rotator cuff)
- •Revision in cases of:
- •Replacement of an "anatomic" prosthesis with a "reversed" prosthesis
- •Conversion of a hemi-arthroplasty into a total arthroplasty
- •Increasing the size of the stem (length and/or diameter)
- •Replacing a glenoid prosthesis
- •Replacing a competitor's prosthesis
- •In rare cases, removing a "reversed" prosthesis and replacing it with an "anatomic" prosthesis
- •Additional inclusion criteria include
- •Patient who read, understood study information and gave informed consent (oral or written depending on specific local regulatory requirements)
- •Willing to return for follow-up evaluations
排除标准
- •Local or systemic infections.
- •Severe muscular, neurological, or vascular deficiency of the affected joint.
- •Bone destruction or poor bone quality liable to affect the stability of the implant (Paget's disease, osteoporosis, etc.)
- •Cases where the corolla cannot be two-thirds covered with bone stock and including the stem/corolla junction.
- •Any concomitant complaint likely to affect the functioning of the implant.
- •Allergy to any of the implant components.
- •Local bone tumors.
- •Patient over 18 under law supervision
结局指标
主要结局
Constant Shoulder Score
时间窗: Pre-operative, 5 years follow-up
The Constant Murley score is a multi-item scale assessing the level of pain and the ability to carry out the normal daily activities of the patient. The test is divided into four subscales: pain (0-15 points), activities of daily living (0-20 points), strength (0-25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (0-40 points). The results are here reported as final score, which ranges from 0 to 100, with 0 representing the worst and 100 the best shoulder function.
次要结局
- Active External Rotation RE1(Pre-operative, 5 years follow-up)
- Passive Elevation(Pre-operative, 5 years follow-up)
- Radiographic Evaluation(Immediate post-operative, 6 weeks follow-up, 6 months follow-up, 1 year follow-up, 2 years follow-up, 3 years follow-up, 4 years follow-up, 5 years follow-up.)
- Active Anterior Elevation(Pre-operative, 5 years follow-up)
- Active External Rotation RE2(Pre-operative, 5 years follow-up)
- Active Lateral Elevation(Pre-operative, 5 years follow-up)
- Passive External Rotation(Pre-operative, 5 years follow-up)
- Survivorship(5 years follow-up)