CT1401
Research type
Research Study
Full title
CT 1401: GLOBAL ICON Stemless Shoulder System Post Market Clinical Follow Up Study
IRAS ID
219886
Contact name
Kris Lee
Contact email
Sponsor organisation
Medical Device Business Services Inc (hereafter referred to as DePuy Synthes)
Clinicaltrials.gov Identifier
Duration of Study in the UK
12 years, 6 months, days
Research summary
Research Summary:
This is a Post-Market Clinical Follow-up (PMCF) study of the Global ICON stemless humeral implant, a CE marked device which will be used within its intended purposes. The device is commercially available to surgeons regardless of whether or not they are involved as Investigators in the study. Patients undergoing shoulder surgery may therefore receive the device regardless of whether or not they participate in the study.
Follow-up assessments and imaging requirements for the research may involve a change to the subjects standard care (this will be determined on a hospital by hospital basis and made clear in the Patient Information Sheet).
The research involves collection of clinical, radiographic and patient reported outcome data (Oxford Shoulder Score and EQ-5D-5L) on patients who receive this device, before and after their shoulder surgery. Pseudonymised data will be provided to the Study Sponsor.
The study is being conducted in Orthopaedic departments in approx 15 hospitals and site within Europe and Canada are being considered. Recruitment is expected to take 2 years. 157 subjects aged 21 to 80 will participate in the study for 10 years following their initial treatment with the device.Lay Summary of Results:
The purpose of this study is two-fold: firstly, the study fulfills the Sponsor obligations for post market clinical follow-up of safety and performance in support of CE mark requirements; secondly, the study data was used to support US and Australian marketing applications.
The study was multi-surgeon, multi-center and geographically diverse with sites in the UK, the Netherlands, Germany, and Canada. The study cohort is similar to the population recently noted within the 2024 UK National Joint Registry (NJR) 21st Annual Report. Within the GLOBAL ICON™ study safety population 51.6% of Subjects are female and the median age at time of surgery was 68; the 2024 NJR 21st Annual Report noted 61.7% of elective stemless total shoulder patients were female and the median age at time of surgery was 68.
The data generated in the study represents mid-term follow-up of clinical and radiographic outcomes, and adverse event reporting for the GLOBAL ICON™ Stemless Shoulder System. The GLOBAL ICON™ Stemless Shoulder system performed as expected within the study cohort through 60-months:
• There were no radiological signs of loosening or continuous radiolucent lines observed in any of the 157 Subjects in the safety population
• There were no Unanticipated Adverse Device Effects reported
• There were no humeral components removed in 98.0% of Subjects
• There were no device-related serious adverse events in 98.7% of Subjects
• At 60 months, the adjusted Constant-Murley Score improved by 62.3 points from baseline
• At the 24-month primary endpoint the adjusted Constant-Murley Score was greater than 85 in 84.8% of Subjects
• Kaplan-Meier Survivorship estimate at 5 years is 98.0% (Lower Confidence Interval 94.1, Upper Confidence Interval 99.4)
Conclusions drawn from this study indicate that the clinical and radiographic data support the reasonable assurance of safety and effectiveness of the GLOBAL ICON™ Stemless Shoulder System. It is reasonable to conclude that the benefits of the GLOBAL ICON™ Stemless Shoulder System for the target population outweighs the risk of surgery when used in accordance with the Instructions for Use.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
17/YH/0227
Date of REC Opinion
31 Aug 2017
REC opinion
Further Information Favourable Opinion