TerminatedNo phase
GLOBAL ICON Stemless Shoulder System Post Market Clinical Follow Up Study
Key facts
- Who runs it
- DePuy Orthopaedics
- Where
- Canada, Germany, Netherlands, and United Kingdom12 sites in 4 countriesChoose a country to see its sites
- Trial code
- Status
- Terminated
- People taking part
- 171 people enrolled
- Started
- 18 Oct 2017
- Ended
- 18 Jun 2024
- Type of study
- Interventional
- Treatments tested
- Global ICON
- Record updated
- 5 August 2025
- Why it stopped
- The study was terminated because of concerns about subject attrition between the 5- and 10-year visits. A nested PMCF study at 10 years was proposed to the regulatory body and it was agreed this was an acceptable approach
Who can take part
- Age
- 21 years to 79 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 2 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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 Inadequate bone stock in the proximal humerus or glenoid fossa for supporting the GLOBAL ICON stemless humeral components Bone that is 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 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
This trial has no sites in United States.
It has sites in 4 countries. Choose a country to see its sites.
About the trial
What the trial wants to find out
This is a Post Market Clinical Follow Up (PMCF) study to monitor the safety and performance of the GLOBAL ICON stemless humeral component. The data gathered will be used to support post market surveillance of the device, and may potentially be used for additional market access purposes.
The group in the trial
- Global ICONOther group
The study device is the GLOBAL ICON stemless humeral component, consisting of the Anchor Plate and Humeral Head.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 5 August 2025