NL-OMON53117招募中不适用
GLOBAL ICON Stemless Shoulder System Post Market Clinical Follow Up Study - GLOBAL ICO
Johnson & Johnson Medical Devices0 个研究点目标入组 60 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
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
- •Subjects meeting all of the following specific criteria will be considered for
- •participation in the study:
- •- severely painful and/or severely disabled Non-Inflammatory Degenerative Joint
- •Disease (NIDJD) resulting from osteoarthritis (OA) or post traumatic arthritis
- •- Patient is willing and able to complete the required post-operative schedule
- •- Patient has provided written Informed Consent to participate
排除标准
- •Subjects will be excluded from participation in the study if they meet any of
- •the following criteria:
- •- Subjects under the age of 21 or over the age of 80 on the day of consent
- •- Subjects who have not reached skeletal maturity, regardless of age
- •- Either preoperatively or intraoperatively bone stock in the proximal humerus
- •or glenoid fossa is determined to be inadequate for supporting the GLOBAL ICON
- •stemless humeral components
- •- Intraoperatively, bone is determined to be too soft or porous to support the
- •implant or that is too hard or brittle to allow for proper bone preparation and
- •fixation, i.e osteoporosis or sclerotic bone, where there could be considerable
- •migration of the prosthesis and/or a chance of fracture of the humerus or
- •- Fractures of the proximal humerus that could compromise the fixation of the
- •GLOBAL ICON stemless humeral components
- •- Subjects who have undergone previous treatment on the study shoulder that may
- •compromise -fixation of the GLOBAL ICON stemless humeral components
- •- Revision of a failed hemi, total or reverse shoulder arthroplasty
- •- Active local or systemic infection
- •- Absent, irreparable or nonfunctional rotator cuff or other essential muscles
- •- Subject is receiving, or is scheduled to receive, treatment that the
- •Investigator considers could affect bone quality, such as chemotherapy or high
- •dose corticosteroids
- •- Subjects who, at the point of enrolment, already have a GLOBAL ICON shoulder
- •replacement or are scheduled to receive, a contralateral shoulder replacement
- •- Subjects who are known to be pregnant or breastfeeding
- •- Subjects who are known drug or alcohol abusers or with psychological
- •disorders that could affect follow-up care or treatment outcomes
- •- Subjects with a known medical condition that the Investigator believes would
- •impact the study outcomes (including, but not limited to osteomyelitis, Paget*s
- •disease, neuropathies such as Charcot*s disease, metastatic or neoplastic
- •- Known polyethylene and/or metal sensitivity or allergy
研究者
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