NCT03312465进行中（未招募）不适用
Anatomical Shoulder™ Domelock System A Multicenter, Prospective and Retrospective, Non-Controlled Post-Market Clinical Follow-up Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 73
- 试验地点
- 8
- 主要终点
- Implant Survivorship
研究概览
简要总结
The objectives of this study are to confirm safety and performance of the Anatomical Shoulder Domelock System when used in hemi or total shoulder arthroplasty by analysis of standard scoring systems, radiographs and adverse event records.
详细描述
This study is a multicenter, prospective and retrospective, non-controlled PMCF study involving orthopaedic surgeons skilled in hemi and total shoulder arthroplasty procedures. A minimum of six study centers will be involved and a total number of 73 implants will be included into the study.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is 18-80 years of age, inclusive
- •Patient is skeletally mature
- •Patient is suffering from severe shoulder pain and disability requiring unilateral or bilateral HSA or TSA based on physical exam and medical history
- •Patient has failed conservative treatment
- •Patient meets at least one of the following indications:
- •Advanced wear and tear of the shoulder joint resulting from degenerative, posttraumatic or rheumatoid arthritis if bone stock is adequate.
- •Avascular necrosis
- •Conditions consequent to earlier operations
- •Optional use in revision: in some medical conditions (e.g., early revision when adequate bone stock exists), the surgeon may opt to use primary implants in a revision procedure.
- •Additional criteria for retrospective patients:
- •patient has been implanted with the Domelock system before site initiation visit.
- •information available must include at minimum demographic information, the operative report and details of the device implanted.
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 meets at least one of the contraindications:
- •Patient's physical conditions that would impair adequate implant support and/or prevent the use of an appropriately sized implant, e.g., previous surgery, insufficient quality or quantity of bone, neuromuscular compromise or vascular deficiency in the affected limb in sufficient degree to endanger the success of the intervention e.g., absence of musculoligamentous supporting structures, joint neuropathy or other conditions that may lead to inadequate skeletal fixation
- •Signs of infection
- •Severe instability secondary to advanced loss of osteochondral structure
- •Charcot's shoulder (neuroarthropathy)
结局指标
主要结局
Implant Survivorship
时间窗: 10 Years
The primary endpoint of this study 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.
次要结局
- Clinical Performance(5 Years)
研究者
研究点 (8)
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