GLOBAL ICON Stemless Shoulder System Post Market Clinical Follow Up Study

NCT03168672 | Terminated Results

• 1 other identifier: CT 1401
• Study Type: interventional
• Target: 171
• Locations: 4 countries
• Sites: 12

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.

Conditions

Osteoarthritis; Post Traumatic Arthritis

Outcome Measures

Primary Outcomes (5)

• Percentage of Participants With Overall Composite Clinical Success

  Percentage of participants with overall composite clinical success at 24 months was reported. Composite success was achieved if each of the following criteria was met: (1) Radiographs indicated that there was no continuous radiolucent line (RLL) around the GLOBAL ICON stemless humeral component, with continuous RLL defined as a radiolucent line greater than (\>) 1millimeter (mm) in all five zones of either anterior-posterior (AP) or Axillary views (2) The adjusted Constant-Murley score was greater than 85, with the adjustment based on the method of Constant (3) No GLOBAL ICON humeral component was removed for any reason (4) There was no device-related serious adverse events.

  At 24 months

• Adjusted Constant-Murley Shoulder Assessment Score

  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 participant is 0-178.6; the range for the Adjusted Constant-Murley score in a female participant 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 participants.

  24 Months

• Continuous Radiolucent Line

  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.

  24 months

• Kaplan Meier Survivorship

  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 participants).

  24 months

• Device-related Serious Adverse Events

  Adverse events are any untoward health issues that occur when compared to a participant'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.

  24 months

Secondary Outcomes (5)

• Mean Adjusted Constant-Murley Score at Baseline, 3, 12, 24, and 60 Months Post-operative

  At Baseline (Day 0), 3, 12, 24, and 60 months

• Mean Oxford Shoulder Score at Baseline, 3, 12, 24, and 60 Months Post-operative

  At Baseline (Day 0), 3, 12, 24, and 60 months

• Mean EuroQol-5 Dimension 5-Level (EQ-5D-5L) Scores by Dimensions at Baseline, 3, 12, 24, and 60 Months Post-operative

  At Baseline (Day 0), 3, 12, 24, and 60 months

• Mean Visual Analog Scale (EQ-VAS) Score at Baseline, 3, 12, 24, and 60 Months Post-operative

  At Baseline (Day 0), 3, 12, 24, and 60 months

• Number of Participants With Radiographic Evidence of Aseptic Loosening of the Global Icon Stemless Humeral Component Immediate Post-operative and 3, 12, 24, and 60 Months Post-operative

  Immediate post operative (0-10 Days), at 3, 12, 24, and 60 months

Study Arms (1)

Global ICON

OTHER

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

Device: Global ICON

Interventions

Global ICON DEVICE

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

Global ICON

Eligibility Criteria

• Age: 21 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• DePuy Orthopaedics: lead

Study Sites (12)

Kingston General Hospital

Kingston, K7L 2V7, Canada

Location

Vulpius Klinik

Bad Rappenau, 74906, Germany

Location

Orthopädische Klinik der Medizinischen Hochschule Hannover im Diakovere Annastift

Hanover, 30625, Germany

Location

Sportklinik Ravensburg

Ravensburg, 88214, Germany

Location

Treant Hospital

Emmen, NL-7824AA, Netherlands

Location

Groene Hart Ziekenhuis

Gouda, 2803 HH, Netherlands

Location

Tergooi Hospital

Hilversum, Netherlands

Location

Woodend Hospital

Aberdeen, AB252ZB, United Kingdom

Location

The Royal Bournemouth Hospital

Bournemouth, BH7 7DW, United Kingdom

Location

North Bristol NHS Trust

Bristol, BS10 5NB, United Kingdom

Location

James Cook University Hospital

Middlesbrough, TS4 3BW, United Kingdom

Location

City Hospital

Nottingham, NG5 1PB, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Limitations and Caveats

Due to investigators decision study was terminated at 5 years. Therefore, results are reported only up to 5 years (60 months).

Results Point of Contact

• Title: Dave Whalen
• Organization: DePuy Synthes

dwhalen@its.jnj.com

574-404-9399

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2017
• First Posted: May 30, 2017
• Study Start: October 18, 2017
• Primary Completion: December 13, 2021
• Study Completion: June 18, 2024
• Last Updated: August 5, 2025
• Results First Posted: May 8, 2025

Record last verified: 2025-07

Locations

CA (1); NL (3); DE (3); GB (5)