DRKS00023639已完成未知
Post-marketing clinical follow-up study on the GLOBAL ICON shaft-free shoulder prosthesis - CT1401
Medizinische Hochschule Hannover0 个研究点目标入组 157 人开始时间: 2021年7月14日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 157
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 80 Years（—）
- 性别
- All
入选标准
- •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 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 Inadequate bone stock in the proximal humerus or glenoid fossa is determined to be inadequate for supporting the GLOBAL ICON stemless humeral components
- •Intraoperatively, bBone that 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 glenoid
- •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
- •Page 13 of 42
- •Confidential Medical Device Business Services, Inc
- •Revision Date14JUN2018Date14MAY2020 Protocol: CT1401
- •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 device
- •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 disorders)
- •Known polyethylene and/or metal sensitivity or allergy
研究者
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