ASHCOM Shoulder System and Its Related Instruments - A Multicenter, Prospective, Non-Controlled Post Market Clinical Follow-up Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Survival of Implant System (Kaplan Meier)
研究概览
简要总结
The objectives of this study are to confirm safety, performance and clinical benefits of the ASHCOM Shoulder System and its related instruments by analysis of standard scoring systems, radiographs and adverse event records.
详细描述
This study is a multicenter, prospective, non-controlled Post-Market Clinical Follow-up study involving orthopaedic surgeons skilled in reverse shoulder arthroplasty procedures. A minimum of three study centers will be involved. A total number of 97 implants will be included into the study.
The primary endpoint is defined by the survival of the implant at 10 years which is based on removal or intended removal of the prosthesis and will be determined using Kaplan Meier method. The safety of the system will be assessed by monitoring the frequency and incidence of adverse events.
The secondary endpoint is defined by the performance and clinical benefits of the ASHCOM Shoulder System at 5 years, which is assessed by the Constant and Murley score. Assessments of the overall pain, functional performance, survival, quality of life and radiographic parameters of all enrolled study subjects will be evaluated in addition.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is capable of understanding the doctor's explanations, following his instructions and is able to participate in the follow-up program.
- •Patient has given written consent to take part in the study by signing the "Patient Consent Form".
- •Patient is 18-80 years of age, inclusive.
- •Patient is skeletally mature.
- •Patient requires a primary, fracture or revision reverse total shoulder replacement for the relief of pain and has significant disability due to gross rotator cuff deficiency.
- •Patient's joint is anatomically and structurally suited to receive the selected implants.
- •Patient has a functional deltoid muscle.
排除标准
- •Patient is unwilling or unable to give consent or to comply with the follow-up program.
- •Patients who have any condition which would in the judgement of the Investigator place the patient at undue risk or interfere with the study. Any patient who is institutionalized, or is a known drug abuser, a known alcoholic or anyone who cannot understand what is required of them.
- •Patient is known to be pregnant or breastfeeding.
- •Patient is a vulnerable subject.
- •Patient meets at least one of the contraindications:
- •Signs of infection
- •Significant injury to the upper brachial plexus
- •Non-functional deltoid muscle
- •Insufficient quality and/or quantity of glenoid or humeral bone
- •Any neuromuscular or vascular disease compromising the affected limb that would endanger the success of the intervention
结局指标
主要结局
Survival of Implant System (Kaplan Meier)
时间窗: 3 years
The primary endpoint is defined by the survival of the implant at 10 years which is based on removal or intended removal of the prosthesis and will be determined using Kaplan Meier method. Due to early study termination, the survival of the implant was analyzed at 3 years.
次要结局
- The Performance and Clinical Benefits of the ASHCOM Shoulder System - Constant Murley Shoulder Score (CM)(Pre-operative (baseline), 1 year, 2 years post-operative)
- Oxford Shoulder Score (OSS)(Pre-operative (baseline), 3-6 months, 1 year, 2 and 3 years post-operative)
- EQ-5D-5L Score(Pre-operative (baseline), 3-6 months, 1 year, 2 and 3 years post-operative)
- Subjective Shoulder Value (SSV)(Pre-operative (baseline), 3-6 months, 1 year, 2 and 3 years post-operative)
- Radiographic Parameters(2 years post-operative)