Anatomical Shoulder™ Inverse/Reverse Post-Market Surveillance Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Zimmer, GmbH
- 入组人数
- 154
- 试验地点
- 7
- 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™ Inverse/Reverse System by analysis of standard scoring systems and radiographs.
Outcome data will be collected using the following standard scoring systems of which summary statistics will be provided:
• Constant and Murley Score to evaluate clinical parameters such as range of motion, power, level of pain and functional ability.
详细描述
This is a multi-centre, non-comparative, prospective post-market surveillance study involving orthopaedic surgeons skilled in shoulder replacement surgery. Each case enrolled will receive an Anatomical Shoulder™ Inverse/Reverse implant. All system components are CE-marked and commercially available. Patients will be selected according to the subject selection criteria.
All patients will undergo pre-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 either 6 weeks or 6 months (according to the hospital's standard care plan) and thereafter at 1, 2, 5 and 10 years post hospital discharge.
There are 5 study centres taking part in this project enrolling in total a maximum of 160 patients.
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 disease or trauma in the affected joint, including cuff-tear arthropathy, failure of prior rotator cuff surgery and irreparable rotator cuff tears associated with loss of glenohumeral stability with the indication for total shoulder arthroplasty.
- •The deltoid muscle has to be intact in all 3 parts (clavicular, acromial as well as spinal).
排除标准
- •Patient is skeletally immature.
- •Patient is pregnant.
- •Patient is unwilling or unable to cooperate in a follow-up program.
- •Patient shows one of the following medical conditions - Chronic fracture, Acute fracture, Axillary nerve lesion, Severe loss of humeral or glenoid bone, Paralysis of the deltoid muscle, Active Infection
- •Patient requires one of the following medical interventions - Implant Revision, Glenoid bone grafting, Autografts
结局指标
主要结局
Functional Performance
时间窗: 10 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
- Survival (Kaplan-Meier)(10 years)