GLOBAL ICON Stemless Shoulder System Post Market Clinical Follow Up Study

Not Applicable

Completed

Conditions: Post Traumatic Arthritis
Osteoarthritis

Interventions: Device: Global ICON

Registration Number: NCT03168672

Lead Sponsor: DePuy Orthopaedics

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 171

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Adjusted Constant-Murley Shoulder Assessment Score.	24 Months	Constant-Murley Score on operative shoulder adjusted for gender and age. Please note that scores are adjusted to reflect gender and age of participants. The Constant-Murley score is divided into four subscales, including pain (15 points maximum), activities of daily living (20 points maximum), ROM (40 points maximum), and strength (25 points maximum). The higher the score, the higher the quality of function (minimum 0, maximum 100) Adjustment may lead to scores above 100 depending on age of group analyzed. The range for the Adjusted Constant-Murley score in a male subject is 0-178.6; the range for the Adjusted Constant-Murley score in a female subject is 0-192.3. Please note the calculations of the maximum Adjusted score assume a perfect score (100) in 100 year old male and female subjects.
Continuous Radiolucent Line	24 months	X-rays are reviewed by an independent radiographic reviewer to determine if a 1 mm wide or greater, continuous radiolucent line around the entire bony border of the GLOBAL ICON Stemless Shoulder implant exists. Such a line may indicate the implant is loosening.
Kaplan Meier Survivorship	24 months	Kaplan Meier Survival Estimate is based upon the number of GLOBAL ICON implants remaining in the study and the number of GLOBAL ICON implants that have been revised (surgically removed from patients)
Device-related Serious Adverse Events	24 months	Adverse events are any untoward health issues that occur when compared to a subject's normal health baseline. Serious adverse events include health events that have led to death or a serious deterioration in health that resulted in life threatening illness/injury, permanent impairment of a body structure, required hospitalization or required medical intervention to prevent life threatening illness/injury or permanent impairment to a body structure or function

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (12): Vulpius Klinik
🇩🇪
Bad Rappenau, Germany
Kingston General Hospital
🇨🇦
Kingston, Canada
Groene Hart Ziekenhuis
🇳🇱
Gouda, Netherlands
Treant Hospital
🇳🇱
Emmen, Netherlands
Tergooi Hospital
🇳🇱
Hilversum, Netherlands
Orthopädische Klinik der Medizinischen Hochschule Hannover im Diakovere Annastift
🇩🇪
Hannover, Germany
Sportklinik Ravensburg
🇩🇪
Ravensburg, Germany
Woodend Hospital
🇬🇧
Aberdeen, United Kingdom
The Royal Bournemouth Hospital
🇬🇧
Bournemouth, United Kingdom
City Hospital
🇬🇧
Nottingham, United Kingdom
James Cook University Hospital
🇬🇧
Middlesbrough, United Kingdom
North Bristol NHS Trust
🇬🇧
Bristol, United Kingdom