Anatomical Shoulder™ Fracture Post-Market Surveillance Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 6
- 主要终点
- Functional Performance
研究概览
简要总结
The purpose of this study is to obtain outcomes data on the Anatomical Shoulder Fracture System by analysis of standard scoring systems and radiographs.
Outcome data will be collected using the following standard scoring systems:
- Constant and Murley Score
详细描述
This is a multi-centre, non-comparative, prospective post-market surveillance study involving surgeons skilled in shoulder replacement surgery. Each case enrolled will receive an Anatomical Shoulder Fracture implant. All system components are CE (Conformité Européenne)-marked and commercially available. Patients will be selected according to the subject selection criteria.
All patients will undergo pe-operative, intra-operative and post-operative physical examination, radiographic evaluation according to the hospital's routine procedure and collection of quality of life metrics. Follow-up evaluations are to be conducted at 6-12 weeks (x-rays only), at 6 months and annually thereafter for a minimum period of 5 years post hospital discharge. Follow-up evaluation at 10 years post hospital discharge is optional.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Age - 18 years minimum.
- •Sex - male and female.
- •General Health - the patient should be able to undergo surgery and participate in a follow-up program based upon physical examination and medical history.
- •Informed Consent - patient or patient's legal representative has signed a 'Patient Informed Consent form'.
- •Indications - Diagnosis of trauma in the affected joint with the indication for shoulder hemiarthroplasty.
排除标准
- •Patient is skeletally immature.
- •Patient is pregnant.
- •Patient is unwilling or unable to cooperate in a follow-up program.
- •Patient is planned for a bilateral shoulder replacement.
- •Patient shows one or more of the following medical conditions:
- •Pathological Fracture
- •Active Infection
- •Patient requires one or more of the following medical interventions:
- •Revision surgery (non-union)
- •Inverse fracture prosthesis
结局指标
主要结局
Functional Performance
时间窗: 5 years
Constant \& Murley Score. This evaluates clinical parameters such as range of motion, power, level of pain and functional ability. The score ranges from 0 - 100 with a higher score representing a better outcome.
次要结局
未报告次要终点