GLOBAL ICON Stemless Shoulder System Post Market Clinical Follow Up Study

Osteoarthritis Clinical Trial

— Global ICON  

Official title:

GLOBAL ICON Stemless Shoulder System Post Market Clinical Follow Up Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03168672
• Other study ID #: CT 1401
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 18, 2017
• Est. completion date: September 18, 2029

Study information

• Verified date: February 2024
• Source: DePuy Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 172
• Est. completion date: September 18, 2029
• Est. primary completion date: December 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 79 Years

Eligibility

Inclusion Criteria:

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 Exclusion Criteria: 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

Related Conditions & MeSH terms

• Osteoarthritis
• Post Traumatic Arthritis

Intervention

Device:
• Global ICON
The study device is the GLOBAL ICON stemless humeral component, consisting of the Anchor Plate and Humeral Head.

Locations

Country	Name	City	State
Canada	Kingston General Hospital	Kingston
Germany	Vulpius Klinik	Bad Rappenau
Germany	Orthopädische Klinik der Medizinischen Hochschule Hannover im Diakovere Annastift	Hannover
Germany	Sportklinik Ravensburg	Ravensburg
Netherlands	Treant Hospital	Emmen
Netherlands	Groene Hart Ziekenhuis	Gouda
Netherlands	Tergooi Hospital	Hilversum
United Kingdom	Woodend Hospital	Aberdeen
United Kingdom	The Royal Bournemouth Hospital	Bournemouth
United Kingdom	North Bristol NHS Trust	Bristol
United Kingdom	James Cook University Hospital	Middlesbrough
United Kingdom	City Hospital	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
DePuy Orthopaedics

Countries where clinical trial is conducted

Canada,  Germany,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adjusted Constant-Murley Score	Mean change from baseline for the specified follow up time points	3, 12, 24, 60 and 120 months post-operative
Other	Oxford Shoulder Score	Mean change from baseline for the specified time points.	3, 12, 24, 60 and 120 months post-operative
Other	EQ-5D-5L dimension score	Mean change from baseline for the specified time points	3, 12, 24, 60 and 120 months post-operative
Other	Radiographic evidence of aseptic loosening	Radiographic evidence of aseptic loosening of the GLOBAL ICON stemless humeral component that does not arise as a result of intraoperative error, from a traumatic event or inappropriate subject behaviour	immediate post-operative, 3, 12, 24, 60 and 120 months
Other	Periprosthetic fracture survivorship	Periprosthetic fracture survivorship of the GLOBAL ICON stemless humeral component where a subject is deemed to be surviving following no radiographic evidence of periprosthetic fracture arising as a result of intraoperative error, traumatic event or inappropriate subject behaviour	24, 60 and 120 months post operative
Other	EQ-VAS score (subscore of EQ-5D-5L)	Mean change from baseline for the specified time points	3, 12, 24, 60 and 120 months post-operative
Primary	Composite success, comprised of radiographs, Constant-Murley, no revisions or serious adverse events.	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 month follow-up visit: Radiographs indicate that there is no continuous radiolucent line around the GLOBAL ICON stemless humeral component The Adjusted Constant-Murley score is greater than 85 No GLOBAL ICON humeral component has been removed for any reason There have been no device related serious adverse events	24 months
Secondary	Adjusted Constant-Murley Score		baseline and 3, 12, 24, 60 and 120 months post-operative
Secondary	Oxford Shoulder Score		baseline and 3, 12, 24, 60 and 120 months post-operative
Secondary	EQ-VAS (subscore of EQ-5D-5L)		baseline and 3, 12, 24, 60, and 120 months post-operative
Secondary	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
Secondary	GLOBAL ICON stemless humeral component survivorship	Overall survivorship of the GLOBAL ICON stemless humeral component where a subject is deemed to be surviving if no components have been removed for any reason.	24, 60 and 120 months post-operative
Secondary	EQ-5D-5L Scores by dimension		baseline and 3, 12, 24, 60, and 120 months post-operative