GLOBAL ICON Stemless Shoulder System Post Market Clinical Follow Up Study

Study Overview
=================
Brief 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.

Official Title
-----------------
GLOBAL ICON Stemless Shoulder System Post Market Clinical Follow Up Study

Conditions
-----------------
Osteoarthritis, Post Traumatic Arthritis

Intervention / Treatment
-----------------
* Device: Global ICON


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 79 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Global ICON<br>The study device is the GLOBAL ICON stemless humeral component, consisting of the Anchor Plate and Humeral Head. | Device: Global ICON<br>* The study device is the GLOBAL ICON stemless humeral component, consisting of the Anchor Plate and Humeral Head.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adjusted Constant-Murley Score |  | baseline and 3, 12, 24, 60 and 120 months post-operative | 
| Oxford Shoulder Score |  | baseline and 3, 12, 24, 60 and 120 months post-operative | 
| EQ-VAS (subscore of EQ-5D-5L) |  | baseline and 3, 12, 24, 60, and 120 months post-operative | 
| 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 | 
| 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 | 
| EQ-5D-5L Scores by dimension |  | baseline and 3, 12, 24, 60, and 120 months post-operative |