OsteoarthritisGlobal ICONNCT03168672
GLOBAL ICON Stemless Shoulder System Post Market Clinical Follow Up Study
A study testing Global ICON in people with Osteoarthritis and Post Traumatic Arthritis, run by DePuy Orthopaedics at 12 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 21 to 79 years
- Conditions the study is for
- Osteoarthritis, Post Traumatic Arthritis
- What is being tested?
- Global ICON
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 12 sitesin 4 countries
- Study dates
- 18 Oct 2017to 18 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
12 sites in 4 countries.
12 sites in 4 countries
United Kingdom5 sites
Woodend Hospital
Aberdeen, AB252ZB
The Royal Bournemouth Hospital
Bournemouth, BH7 7DW
North Bristol NHS Trust
Bristol, BS10 5NB
James Cook University Hospital
Middlesbrough, TS4 3BW
City Hospital
Nottingham, NG5 1PB
Germany3 sites
Vulpius Klinik
Bad Rappenau, 74906
Orthopädische Klinik der Medizinischen Hochschule Hannover im Diakovere Annastift
Hanover, 30625
Sportklinik Ravensburg
Ravensburg, 88214
Netherlands3 sites
Treant Hospital
Emmen, NL-7824AA
Groene Hart Ziekenhuis
Gouda, 2803 HH
Tergooi Hospital
Hilversum
About this study
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.
Read the 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.
- Conditions
- Osteoarthritis, Post Traumatic Arthritis
- Being tested
- Global ICON
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Global ICONDevice
The study device is the GLOBAL ICON stemless humeral component, consisting of the Anchor Plate and Humeral Head.
| Study group | Role | What they receive |
|---|---|---|
| Global ICON | Other | The study device is the GLOBAL ICON stemless humeral component, consisting of the Anchor Plate and Humeral Head. Receives: Device: Global ICON |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 24 months
Secondary outcomes (5)
Mean Adjusted Constant-Murley Score at Baseline, 3, 12, 24, and 60 Months Post-operative
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.
Measured: At Baseline (Day 0), 3, 12, 24, and 60 months
Mean Oxford Shoulder Score at Baseline, 3, 12, 24, and 60 Months Post-operative
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).
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Immediate post operative (0-10 Days), at 3, 12, 24, and 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start18 Oct 2017
- Primary completion13 Dec 2021
- Study completion18 Jun 2024
Why it stopped: The study was terminated because of concerns about subject attrition between the 5- and 10-year visits. A nested PMCF study at 10 years was proposed to the regulatory body and it was agreed this was an acceptable approach
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- DePuy Orthopaedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03168672
- Sponsor's protocol ID
- CT 1401
- Acronym
- Global ICON
- Status last verified
- Jul 2025
- First submitted
- 18 May 2017
- Last updated
- 5 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GLOBAL ICON Stemless Shoulder System Post Market Clinical Follow Up Study
- ClinicalTrials.gov ID
- NCT03168672
- Acronym / sponsor ID
- Global ICON / CT 1401
- Conditions
- Osteoarthritis, Post Traumatic Arthritis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated because of concerns about subject attrition between the 5- and 10-year visits. A nested PMCF study at 10 years was proposed to the regulatory body and it was agreed this was an acceptable approach
- Enrolment
- 171 participants (actual)
- Lead sponsor
- DePuy OrthopaedicsIndustry (pharma, biotech, devices)
- Study start
- 18 Oct 2017 (actual)
- Primary completion
- 13 Dec 2021 (actual)
- Study completion
- 18 Jun 2024 (actual)
- First posted
- 30 May 2017 (actual)
- Results
- Posted 8 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Global ICON | Other | Device: Global ICONThe study device is the GLOBAL ICON stemless humeral component, consisting of the Anchor Plate and Humeral Head. |
Who may qualify
- Ages
- 21 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Global ICONThe study device is the GLOBAL ICON stemless humeral component, consisting of the Anchor Plate and Humeral Head. | Device | Global ICON |
Primary outcome
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.
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.
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.
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).
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.
5 secondary outcomes
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
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
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 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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Global ICON in people with Osteoarthritis and Post Traumatic Arthritis, run by DePuy Orthopaedics at 12 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United Kingdom, Germany, Netherlands, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Overall Composite Clinical Success (time frame: At 24 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.