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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