Retrospective and Prospective, Multicenter Study on T.E.S.S.® V3 (Implants and Instrumentation)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 67
- 试验地点
- 3
- 主要终点
- Implant survival at 10 years
研究概览
简要总结
This is a multicenter, retrospective and prospective, non-controlled post market surveillance study. The objectives of this study are to confirm safety, performance and clinical benefits of the T.E.S.S.® Version 3 Anatomic and Reverse Modular Total shoulder prosthesis and its instrumentation.
详细描述
The T.E.S.S.® (Total Evolutive Shoulder System) was developed to provide, with one instrumentation, a complete solution for all indications for shoulder arthroplasty: centered and eccentric rheumatoid osteoarthritis, necrosis, proximal fracture and mal-union of the humeral head. The T.E.S.S.® Modular system can be used in anatomic or reverse configurations with or without the use of a stem, providing a solution for hemi-arthroplasty, total shoulder arthroplasty and revision. The same instrumentation allows implantation of all versions of the T.E.S.S.®.
A maximum of 5 study centers will be involved in Europe. A total number of 146 implants, 73 T.E.S.S.® anatomic and 73 T.E.S.S.® reverse, will be included into the study. Each clinical site will be allowed to enroll a maximum 88 patients (60% of the total study cohort). Ethics Committee (EC) approval has to be obtained prior to conducting this study. All potential subjects will be required to participate in an informed consent process and sign the EC approved written informed consent prior to study enrollment.
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
- •Patient is 18 years or older and skeletally mature
- •Patient is capable of understanding the surgeon's explanations and following his instructions, able and willing to participate in the follow-up program
- •Patient gave consent to take part in the study by signing the Informed Consent Form
- •Patient operated from January 2013 and received the Anatomic or Reverse T.E.S.S.® V3 Modular Total Shoulder System to relieve pain and restore the joint function
- •Patient has adequate quality and quantity of bone stock to support the prosthesis
- •Patient meets at least one of the following indications:
- •For anatomic type:
- •Centered osteoarthritis of the shoulder
- •Humeral head fractures
- •Rheumatoid arthritis (with intact rotator cuff)
- •Avascular necrosis of the humeral head
- •Revision of a hemi-arthroplasty with a total arthroplasty
- •Revision of a reverse prosthesis with an anatomic prosthesis
- •Revision to increase the size of the stem (length and/or diameter)
- •Revision of a glenoid prosthesis, a glenoid insert or a competitor's prosthesis
- •For reverse type:
- •Offset osteoarthritis of the shoulder
- •Massive and non-repairable rotator cuff tears
- •Rheumatoid arthritis (with degenerative rotator cuff)
- •Revision of an anatomic prosthesis with a reverse prosthesis
- •Revision to increase the size of the stem (length and/or diameter)
- •Revision of a glenoid prosthesis, a glenoid insert or a competitor's prosthesis
排除标准
- •Patient is unwilling or unable to give consent or to comply with the follow-up program
- •Patient is known to be pregnant or breastfeeding
- •Patient has any condition that would, in the judgment of the Investigator, place the patient at undue risk or interfere with the study
- •Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, anticipated to be non-compliant)
- •Patient who displays any of the following contra-indications cannot be included in this study:
- •Local or systemic infections
- •Severe muscular, neurological, or vascular deficiency of the affected joint
- •Poor bone quality likely to prevent osseointegration or to affect the long-term stability of the implant (Paget's disease, osteoporosis)
- •Any concomitant conditions likely to affect the function of the implant
- •Allergy to any of the implant components
- •Do not use the modular humeral version (screwed connection) in cases where the corolla cannot be two-thirds covered with bone stock and including the screwed modular stem/corolla junction
结局指标
主要结局
Implant survival at 10 years
时间窗: 10 years
The functional performance and clinical benefits will be determined by assessing the survival of the implant at 10 years using the Kaplan-Meier method. The survivorship of the implanted device will be recorded from the date of implantation to the date of revision or intended revision up to 10 years post-operatively.
Frequency and incidence of adverse events
时间窗: 10 years
The safety will be assessed by monitoring the frequency and incidence of adverse events. Adverse events will be collected in an Adverse Event Form, which gathers information on the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome.
次要结局
- Constant and Murley score(10 years)
- EQ-5D-5L questionnaire(10 years)
- Radiographic Evaluation(10 years)