Shoulder Replacement Device for Osteoarthritis

(Global ICON Trial)

No longer recruiting at 12 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: DePuy Orthopaedics

Must not be taking: Chemotherapy, Corticosteroids

Disqualifiers: Osteoporosis, Infection, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: Immediate post-operative

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess the safety and performance of a new shoulder replacement device called the GLOBAL ICON. It is designed for individuals with severe shoulder osteoarthritis that is not caused by inflammation. Participants must follow the post-surgery schedule and sign a consent form. This trial may suit those with severe shoulder pain or disability due to osteoarthritis or past injuries. As an unphased trial, it offers participants the chance to contribute to the development of innovative treatments for shoulder conditions.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that this shoulder replacement device is safe for osteoarthritis?

Research has shown that the Global ICON stemless shoulder replacement device is generally safe. Studies have found that patients using this device achieved excellent results over 12 and 24 months. Importantly, no problems with the implant were reported during this period, suggesting that patients tolerate the device well. Clinical results and patient feedback support these findings, indicating positive experiences with the Global ICON device in the short to medium term. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Global ICON device is unique because it offers a stemless solution for shoulder replacement, which is particularly beneficial for patients with osteoarthritis. Unlike traditional shoulder replacements that require a stem inserted into the arm bone, the GLOBAL ICON uses an anchor plate and humeral head design. This approach can potentially result in less bone removal during surgery, leading to a faster recovery and less pain. Researchers are excited about this treatment because it may improve joint stability and function, while the less invasive nature may reduce complications associated with stemmed implants.

What evidence suggests that this device is effective for osteoarthritis?

Research has shown that the Global ICON stemless shoulder replacement, which participants in this trial will receive, works well for people with osteoarthritis. Studies found that patients experienced excellent results 12 and 24 months after receiving the implant, with no device-related problems. These studies suggest that the Global ICON effectively relieves pain and improves shoulder function. The device also performed well in both clinical check-ups and X-rays, similar to other stemless shoulder replacements. Overall, promising data supports the Global ICON's safety and effectiveness in treating shoulder osteoarthritis. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults with severe joint pain or disability from non-inflammatory arthritis, like osteoarthritis. Participants must be able to follow the study schedule and give consent. It's not for those under 21 or over 80, with previous shoulder treatments that could affect results, pregnant/breastfeeding women, people with certain bone diseases or conditions affecting bone quality, known allergies to implant materials, substance abuse issues, psychological disorders impacting treatment outcomes, or fractures compromising implant fixation.

Inclusion Criteria

I am willing and able to follow the post-surgery plan.

Patient has provided written Informed Consent to participate

I have severe joint pain or disability from osteoarthritis or injury-related arthritis.

Exclusion Criteria

My shoulder bone is too weak to support certain types of shoulder implants.

My bones are either too soft or too hard for safe implant surgery.

I am receiving treatment that may affect my bone health.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the GLOBAL ICON stemless humeral component implant

Immediate post-operative

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Visits at 3, 12, 24, 60, and 120 months post-operative

Long-term follow-up

Extended monitoring of device survivorship and performance

60 to 120 months

What Are the Treatments Tested in This Trial?

Interventions

• Global ICON

Trial Overview The GLOBAL ICON stemless humeral component is being tested in this study. The aim is to monitor its safety and performance after it has been marketed. This involves collecting data on how well it works and any potential issues in patients who have received this shoulder replacement device.

How Is the Trial Designed?

Group I: Global ICON Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

DePuy Orthopaedics

Lead Sponsor

Trials

81

Recruited

26,000+

Massimo Calafiore

DePuy Orthopaedics

Chief Executive Officer since 2023

MBA from Harvard Business School

Dr. Michael Stein

DePuy Orthopaedics

Chief Medical Officer since 2023

MD from University of Michigan

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10648431/

Medium-Term Clinical Outcomes of the Global Icon ... The Global Icon stemless replacements have excellent clinical outcomes in this cohort at 12- and 24-month follow-up with no implant-related complications.

2. orthopedicreviews.openmedicalpublishing.org orthopedicreviews.openmedicalpublishing.org/article/37042-short-term-results-of-a-new-anatomic-stemless-shoulder-arthroplasty-a-prospective-multicentre-study

Short-term results of a new anatomic stemless shoulder ... The new GLOBAL ICON stemless TSA showed good clinical and radiographic results at short-term follow up which were comparable to early results of other stemless ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12227341/

Promising short-term results after anatomical total shoulder ... The aim of this prospective study was, therefore, to evaluate the clinical and radiographic 2-year results of the Global Icon™ Stemless Shoulder ...

4. researchgate.net researchgate.net/publication/374997528_Medium-Term_Clinical_Outcomes_of_the_Global_Icon_Stemless_Shoulder_System_Results_of_a_2-Year_Follow-Up

(PDF) Medium-Term Clinical Outcomes of the Global Icon ... The Global Icon stemless replacements have excellent clinical outcomes in this cohort at 12- and 24-month follow-up with no implant-related complications.

5. mdpi.com mdpi.com/2077-0383/12/21/6745/review_report

Medium-Term Clinical Outcomes of the Global Icon ... The authors asses the outcomes (at 12 and 24 months) of primary total shoulder arthroplasty using the Global Icon stemless shoulder replacement.

6. mdpi.com mdpi.com/2077-0383/12/21/6745

Medium-Term Clinical Outcomes of the Global Icon ... The Global Icon stemless replacements have excellent clinical outcomes in this cohort at 12- and 24-month follow-up with no implant-related complications.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37959211/

Medium-Term Clinical Outcomes of the Global Icon ... The primary aim of this study was to assess the medium-term outcomes of the Global Icon stemless shoulder replacement in patients who have ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03877315

Patient Reported Outcome After Stemmed Versus Stemless ... The purpose of the study is to compare the short-term, patient-reported outcome of stemless and stemmed total shoulder arthroplasty. Detailed Description.