Post-marketing clinical follow-up study on the GLOBAL ICON shaft-free shoulder prosthesis
- Conditions
- Primary osteoarthritis of other joints : shoulder region [clavicle, scapula, acromioclavicular, glenohumeral, sternoclavicular joint].Posttraumatic osteoarthritis of other joints : shoulder region [clavicle, scapula, acromioclavicular, glenohumeral, sternoclavicular joint].
- Registration Number
- DRKS00023639
- Lead Sponsor
- Medizinische Hochschule Hannover
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 157
•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
• 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
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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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of this PMCF study is to confirm device survivorship of the GLOBAL ICON stemless humeral component at 24 months post-operative.<br>The primary endpoint in this study is a composite success endpoint at 24 months post-operative, where an individual study subject is deemed to be a composite success if each of the following criteria is met at the 24 months follow-up visit:<br>• Radiographs indicate that there is no continuous radiolucent line around the GLOBAL ICON stemless humeral component<br>• The adjusted Constant-Murley score is greater than 85<br>• No GLOBAL ICON humeral component has been removed for any reason<br>• There have been no device- related serious adverse events
- Secondary Outcome Measures
Name Time Method Secondary objectives include the evaluation of clinical and radiographic performance and safety outcomes. The secondary endpoints are:<br>• Mean adjusted Constant-Murley Score at baseline and 3, 12, 24, 60 and 120 months post-operative<br>• Mean Oxford Shoulder Score at baseline, and 3, 12, 24, 60 and 120 months post-operative<br>• Mean EQ-5D-5L Scores by dimension and EQ-VAS at baseline, and at 3, 12, 24, 60, and 120 months post-operative<br>• Radiographic evidence of aseptic loosening of the GLOBAL ICON stemless humeral component immediate post-operative and 3, 12, 24, 60, and 120 months post-operative