Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Anatomical Shoulderᵀᴹ 2.0 Fracture System (Implants and Instrumentation) - A Retrospective and Prospective Consecutive Series Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Incidence and frequency of revisions [Product safety based on implant survivorship]
研究概览
简要总结
The study is a multicenter, retrospective and prospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to collect long-term data confirming safety, performance and clinical benefits of the Anatomical Shoulder 2.0 Fracture System (Implants and Instrumentation) when used for fracture shoulder arthroplasty. The primary objective is the assessment of safety by analyzing implant survivorship. This will be established by recording the incidence and frequency of revisions, complications and adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified.
The secondary objective is the assessment of performance and clinical benefits by recording patient-reported clinical outcome measures (PROMs) as well as radiographic outcomes.
详细描述
The Anatomical Shoulder 2.0 Fracture System is intended for use in prosthetic replacement of the proximal humerus and the glenoid articular surface of the scapula during total, hemi and fracture shoulder arthroplasty. The system is intended for long-term implantation into the human shoulder joint to relieve pain and restore function in patients with adequate bone stock to support the prosthesis.
Two sites will be involved in this study. The aim is to include a total of 78 consecutive series cases who received the Anatomical Shoulder 2.0 Fracture starting from 2014. All potential study subjects will be required to participate in the Informed Consent Process.
Baseline data from the preop, intraop and immediate post-op intervals will be available in medical notes and collected retrospectively. During follow-up visits at 1, 3, 5, 7 and 10 years post-op (depending on patients' date of surgery), the patient will be asked to complete patient questionnaires. Moreover, a clinical assessment and a radiographic evaluation will be conducted. In addition, any complications and adverse events will also be collected during these follow-up visits.
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
- •Patients 18 years or older and skeletally mature
- •Patients capable of understanding the surgeon's explanations and following his instructions, able and willing to participate in the follow-up program and who gave consent to take part in the study
- •Replacement of the proximal humerus and the glenoid articular surface of the scapula during total-, hemi- and fracture shoulder arthroplasty in treatment of the following:
- •Complex 3- and 4- part fractures of the proximal humerus with subluxation of the head fragment
- •Complex 3- and 4- part fractures of the proximal humerus with loosening of the spongiosa in the head fragment
- •Complex 3- and 4- part fractures of the proximal humerus with additional cross split of the head fragment
- •Fracture instability after osteosynthesis of 3- and 4-part fracture fragments of the proximal humerus
- •Posttraumatic necrosis of the humeral head
- •Posttraumatic arthrosis after humeral head fracture
排除标准
- •Patients who are unwilling or unable to give consent, not willing to return for study required follow-up visits and/or to comply with the follow-up program.
- •The patient is known to be pregnant or breastfeeding
- •Patients who have 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).
- •Patients with plans to relocate during the study follow-up period
- •Signs of infection
- •Extensive stiffening of the shoulder joint without pain
结局指标
主要结局
Incidence and frequency of revisions [Product safety based on implant survivorship]
时间窗: 3-10 years
Safety will be assessed by recording and analyzing the incidence and frequency of revisions, complications and adverse events. A Kaplan Meier survival curve will be calculated.
次要结局
- Constant and Murley Score(3-10 years)
- EuroQol Five Dimensions Questionnaire(3-10 years)
- X-rays(3-10 years)
- Oxford Shoulder Score(3-10 years)