NL-OMON47760已完成不适用
A multicentre, prospective clinical study analysing outcomes of shoulder arthroplasty with SMR STEMLESS - SMR Stemless
AMSA0 个研究点目标入组 50 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Patient is requiring primary unilateral or bilateral anatomic or reverse
- •arthroplasty based on physical examination and medical history;
- •- Good bone quality evaluated by the Investigator on the basis of a risk
- •factors analysis (included MORES/SCORE questionnaires) and the intraoperative
- •evaluation;
- •- A diagnosis in the target shoulder of one or more of the following:
- •Primary osteoarthritis;
- •Secondary osteoarthritis;
- •Post-traumatic arthritis;
- •Rheumatoid arthritis;
- •Avascular necrosis of the humeral head (radiologically less than 20%);
- •Cuff tear arthropathy.
- •- Patient submitted to previous conservative non-surgical treatments;
- •- Patient is willing and able to complete scheduled follow-up evaluations as
- •described in the Informed Consent;
- •- Patient has participated in the Informed Consent process and has signed the
- •Informed Consent form previously approved by the Ethics Committee.
排除标准
- •- Patient requiring revision shoulder arthroplasty;
- •- Osteoporosis with a history of non-traumatic fractures;
- •- Steroid injections within the previous 3 months;
- •- Contralateral shoulder replacement within the previous 3 months;
- •- Extensive avascular necrosis (radiologically more than 20%);
- •- Meta-epiphyseal bony defect (including large cysts);
- •- Post-traumatic tuberosity non-union;
- •- Ongoing septicaemia;
- •- Significant proven or suspicious infection of the target shoulder or any
- •serious infectious disease before the study according to the Investigator;
- •- Significant neurological or musculoskeletal disorders that may compromise
- •functional recovery;
- •- Not recovered axillary nerve palsy;
- •- Non functioning deltoid muscle;
- •- Known or suspicious hypersensitivity to the metal or other components and
- •materials of the implant;
- •- Recurrent medical history of immune-mediated reactions or other systemic
- •immune disorders;
- •- Current treatment or treatment for any malignancy within the previous 2 years
- •before the preoperative visit;
- •- Previous organ transplant;
- •- Women of childbearing potential who are pregnant, nursing, or planning
- •to become pregnant.
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