NCT03168672

GLOBAL ICON Stemless Shoulder System Post Market Clinical Follow Up Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 171 (actual)
• Sponsor: DePuy Orthopaedics · Industry
• Sex: All
• Age: 21 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This study will be multi-centre and non-comparative. Subjects will be recruited and followed up at similar intervals to reflect the standard clinical practice and intended population for wider use of the device. 157 non-randomised subjects will be recruited from approximately 15 sites. A maximum of 30 subjects may be recruited from one site. More than one implanting surgeon may recruit subjects at each site as a designated sub-Investigator. The primary objective of this PMCF study is to confirm device survivorship of the GLOBAL ICON stemless humeral component at 24 months post-operative. The secondary objectives include the evaluation of clinical performance, radiographic performance and safety outcomes at 3, 12, 24, 60 and 120 months post-operatively. Tertiary endpoints in the study will include a mean change from baseline for the Adjusted Constant-Murley Score, the Oxford Shoulder Score, the EQ-5D-5L dimension score and EQ-VAS scores. Radiographic evidence of aseptic loosening and periprosthetic fracture survivorship of the GLOBAL ICON stemless humeral component will be assessed.

Conditions

• Osteoarthritis
• Post Traumatic Arthritis

Interventions

Type	Name	Description
DEVICE	Global ICON	The study device is the GLOBAL ICON stemless humeral component, consisting of the Anchor Plate and Humeral Head.

Timeline

• Start date: 2017-10-18
• Primary completion: 2021-12-13
• Completion: 2024-06-18
• First posted: 2017-05-30
• Last updated: 2025-08-05
• Results posted: 2025-05-08

Locations

12 sites across 4 countries: Canada, Germany, Netherlands, United Kingdom