GLOBAL ICON Stemless Shoulder System Post Market Clinical Follow Up Study (Global ICON)

July 16, 2025 updated by: DePuy Orthopaedics
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
171

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Kingston, Canada, K7L 2V7
        • Kingston General Hospital
  • Germany
      • Bad Rappenau, Germany, 74906
        • Vulpius Klinik
      • Hannover, Germany, 30625
        • Orthopädische Klinik der Medizinischen Hochschule Hannover im Diakovere Annastift
      • Ravensburg, Germany, 88214
        • Sportklinik Ravensburg
  • Netherlands
      • Emmen, Netherlands, NL-7824AA
        • Treant Hospital
      • Gouda, Netherlands, 2803 HH
        • Groene Hart ziekenhuis
      • Hilversum, Netherlands
        • Tergooi Hospital
  • United Kingdom
      • Aberdeen, United Kingdom, AB252ZB
        • Woodend Hospital
      • Bournemouth, United Kingdom, BH7 7DW
        • The Royal Bournemouth Hospital
      • Bristol, United Kingdom, BS10 5NB
        • North Bristol NHS Trust
      • Middlesbrough, United Kingdom, Ts4 3Bw
        • James Cook University Hospital
      • Nottingham, United Kingdom, NG5 1PB
        • City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Global ICON
The study device is the GLOBAL ICON stemless humeral component, consisting of the Anchor Plate and Humeral Head.
Device: Global ICON
The study device is the GLOBAL ICON stemless humeral component, consisting of the Anchor Plate and Humeral Head.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Continuous Radiolucent Line
Time Frame: 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.
24 months
Percentage of Participants With Overall Composite Clinical Success
Time Frame: At 24 months
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
Time Frame: 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 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
Kaplan Meier Survivorship
Time Frame: 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 participants).
24 months
Device-related Serious Adverse Events
Time Frame: 24 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean Adjusted Constant-Murley Score at Baseline, 3, 12, 24, and 60 Months Post-operative
Time Frame: At Baseline (Day 0), 3, 12, 24, and 60 months
Constant-Murley Score was adjusted to reflect gender and age of participants. The Constant-Murley score was 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 was 0-178.6; the range for the Adjusted Constant-Murley score in a female participant was 0-192.3. The calculations of the maximum Adjusted score assume a perfect score (100) in 100 year old male and female participants.
At Baseline (Day 0), 3, 12, 24, and 60 months
Mean Oxford Shoulder Score at Baseline, 3, 12, 24, and 60 Months Post-operative
Time Frame: At Baseline (Day 0), 3, 12, 24, and 60 months
The Oxford Shoulder Score (OSS) was a patient-based questionnaire used to assess shoulder pain after surgery. It consisted of 12 questionnaire items with 5 ordinal response options for each question. Each response was scored from 0 to 4 points (4 = best/least problems and 0=worst/unbearable pain). All item scores across 12 questions were summed to produce a scale of 0-48 (where a higher score reflected best/least problems).
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
Time Frame: At Baseline (Day 0), 3, 12, 24, and 60 months
Mean EQ-5D-5L scores by dimensions at baseline, 3, 12, 24, and 60 months were reported. EQ-5D-5L consisted of the EQ-5D-5L descriptive system and the EQ Visual Analogue Scale (EQ-VAS). The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5-item index score was transformed into a utility score between 0 (worst health state) and 1 (best health state). Higher score indicated good health. EQ-VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Positive change in score indicated improvement.
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
Time Frame: At Baseline (Day 0), 3, 12, 24, and 60 months
EQ-5D-5L consisted of the EQ-5D-5L descriptive system and the EQ-VAS. EQ-VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Positive change in score indicated improvement.
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
Time Frame: Immediate post operative (0-10 Days), at 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 were reported. Aseptic Loosening was evaluated using all available imaging. Progressing radiolucencies and/or stress shielding indicated aseptic loosening.
Immediate post operative (0-10 Days), at 3, 12, 24, and 60 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adjusted Constant-Murley Score
Time Frame: 3, 12, 24, 60 and 120 months post-operative
Mean change from baseline for the specified follow up time points
3, 12, 24, 60 and 120 months post-operative
Oxford Shoulder Score
Time Frame: 3, 12, 24, 60 and 120 months post-operative
Mean change from baseline for the specified time points.
3, 12, 24, 60 and 120 months post-operative
EQ-5D-5L dimension score
Time Frame: 3, 12, 24, 60 and 120 months post-operative
Mean change from baseline for the specified time points
3, 12, 24, 60 and 120 months post-operative
Radiographic evidence of aseptic loosening
Time Frame: immediate post-operative, 3, 12, 24, 60 and 120 months
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
Periprosthetic fracture survivorship
Time Frame: 24, 60 and 120 months post operative
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
EQ-VAS score (subscore of EQ-5D-5L)
Time Frame: 3, 12, 24, 60 and 120 months post-operative
Mean change from baseline for the specified time points
3, 12, 24, 60 and 120 months post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
DePuy Orthopaedics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 18, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 13, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 18, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 18, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 30, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 5, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CT 1401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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