Shoulder Implant for Arthritis

Not currently recruiting at 5 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Zimmer Biomet

Disqualifiers: Osteoporosis, Osteomalacia, Metabolic disorders, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Surgical procedure

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new shoulder implant for individuals with arthritis and a severely damaged rotator cuff. The goal is to determine the safety and effectiveness of these implants in shoulder surgeries. Researchers are evaluating two different implants: the Comprehensive Mini Humeral Tray and the Comprehensive Reverse Augmented Glenoid, to assess their performance in surgeries. This trial may suit individuals with severe shoulder arthritis and a very weak rotator cuff, particularly if previous shoulder surgeries were unsuccessful. Participants must be able and willing to attend all follow-up appointments. As an unphased trial, this study provides a unique opportunity to contribute to the development of innovative shoulder implants.

Do I need to stop 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 coordinators or your doctor.

What prior data suggests that this shoulder implant is safe for arthritis patients?

Research has shown that the Comprehensive Mini Humeral Tray used in shoulder treatments yields promising results. Patients report improved shoulder movement and reduced pain. The implant remains stable and well-received, indicating general tolerance.

For the Comprehensive Reverse Augmented Glenoid, studies indicate a good initial track record. It effectively helps restore shoulder function. Short-term safety appears positive, though information on long-term use is limited.

Both treatments seem safe and stable for short-term improvement of shoulder issues. However, the long-term effects of the glenoid remain unclear. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the Comprehensive Mini Humeral Tray and the Comprehensive Reverse Porous Augmented Glenoid because these devices offer new approaches for patients with severe rotator cuff deficiencies. Unlike traditional shoulder implants, which may not fully accommodate the anatomical and functional deficits in these patients, these new devices are designed specifically for reverse shoulder arthroplasty. The Comprehensive Mini Humeral Tray provides a more compact design that fits better with the patient's existing shoulder structure, potentially leading to improved mobility and reduced recovery time. Meanwhile, the Comprehensive Reverse Porous Augmented Glenoid features a porous design that promotes better bone integration, offering greater implant stability and longevity. These innovations could significantly improve outcomes for individuals suffering from arthritic shoulder conditions with rotator cuff deficiencies.

What evidence suggests that this shoulder implant is effective for arthritis?

Research shows that the Comprehensive Mini Humeral Tray, a treatment in this trial used in reverse shoulder replacement surgery, has led to good results. Studies comparing different implant combinations have found stability and effectiveness two years post-surgery. For the Comprehensive Reverse Augmented Glenoid, another treatment option in this trial, special baseplates have improved implant stability and function. These advancements in reverse shoulder replacement have benefited patients with severe shoulder arthritis. Overall, both treatments in this trial have shown promise in enhancing shoulder movement and stability. ^{1 3 6 7 8}

Who Is on the Research Team?

Hillary Overholser

Principal Investigator

Zimmer Biomet

Are You a Good Fit for This Trial?

This trial is for adults over 18 who need shoulder replacement due to severe arthritis or rotator cuff injuries and have a working deltoid muscle. They must be able to follow the study plan and give informed consent. It's not for those with osteoporosis, metabolic bone diseases, rapid joint destruction, current substance abuse, infection risks, or uncooperative patients.

Inclusion Criteria

I am physically fit for implants and my shoulder muscle works well.

I have severe shoulder damage or a failed shoulder replacement with major tendon issues.

Patient must be able and willing to complete the protocol required follow-up

Exclusion Criteria

I have infections that could spread to the site of a medical implant.

I have been diagnosed with osteomalacia.

My X-rays show rapid joint damage or significant bone loss.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo reverse shoulder arthroplasty using the Comprehensive Reverse Shoulder System

Surgical procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment, including implant survivorship and adverse events

10 years

What Are the Treatments Tested in This Trial?

Interventions

• Comprehensive Mini Humeral Tray
• Comprehensive Reverse Augmented Glenoid

Trial Overview The safety and performance of two shoulder implant components—the Comprehensive Mini Humeral Tray and Porous Augmented Glenoid—are being tested in people needing new shoulders or revisions. The study observes patients at multiple centers without randomizing treatment groups.

How Is the Trial Designed?

Group I: Comp. Rev. Porous Augmented Glenoid Experimental Treatment 1 Intervention

Subjects with a grossly deficient rotator cuff in need of a reverse shoulder arthroplasty who met the inclusion/exclusion criteria and received the Comprehensive Reverse Porous Augmented Glenoid.

Group II: Comp. Rev. Mini Humeral Tray Experimental Treatment 1 Intervention

Subjects with a grossly deficient rotator cuff in need of a reverse shoulder arthroplasty who met the inclusion/exclusion criteria and received the Comprehensive Reverse Mini Humeral Tray

Who Is Running the Clinical Trial?

Zimmer Biomet

Lead Sponsor

Trials

383

Recruited

67,800+

Dr. Nitin Goyal

Zimmer Biomet

Chief Medical Officer since 2021

MD from Harvard Medical School

Ivan Tornos

Zimmer Biomet

Chief Executive Officer since 2023

MBA from the University of Miami School of Business, BBA in Finance and International Marketing and Management from the University of Georgia Terry College of Business

Published Research Related to This Trial

The study analyzed 12 CT scans to create a 3D biomechanical model of the shoulder, testing 17 different positions for the humeral tray in reverse shoulder arthroplasty, revealing that the direction of the offset significantly affects impingement and muscle functionality.

Maximizing impingement-free range of motion was best achieved with a posterolateral tray offset, while maximizing muscle moment arms required a medial tray offset, indicating that optimal tray placement should be tailored to individual patient needs due to the conflicting outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of humeral tray placement on impingement-free range of motion and muscle moment arms in reverse shoulder arthroplasty. Glenday, J., Kontaxis, A., Roche, S., et al.[2020]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37898968/

Mini-augmented glenoid baseplate and mini-humeral tray ... Mini-augmented glenoid baseplate and mini-humeral tray reverse total shoulder arthroplasty implant comparisons: two-year clinical outcomes.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1058274624006281

Shoulder Assessing the efficacy: mid-term clinical and ... This study validates the efficacy of a straight short stem for acceptable clinical outcomes and implant stability in RSA.

3. jsesinternational.org jsesinternational.org/article/S2666-6383(25)00197-5/fulltext

Augmented vs. standard glenoid baseplate use in reverse ... Mini-augmented glenoid baseplate and mini-humeral tray reverse total shoulder arthroplasty implant comparisons: two-year clinical outcomes.

4. withpower.com withpower.com/trial/phase-joint-diseases-7-2018-1ed9d

Shoulder Implant for Arthritis · Info for Participants What data supports the effectiveness of the treatment Comprehensive Mini Humeral Tray, Comprehensive Reverse Augmented Glenoid for shoulder arthritis?

5. researchgate.net researchgate.net/publication/379259556_A_two-year_comparison_of_reverse_total_shoulder_arthroplasty_mini-humeral_tray_and_augmented_mini-glenoid_baseplate_implants_vs_standard_implants

A two-year comparison of reverse total shoulder ... This study evaluated the clinical efficacy of three different RTSA glenoid baseplate and offset humeral tray combinations for patient-reported ...

6. zimmerbiomet.com zimmerbiomet.com/en/products-and-solutions/specialties/shoulder/comprehensive-reverse-shoulder-system.html

Comprehensive Reverse Shoulder System Zimmer Biomet's Comprehensive Reverse Shoulder System offers unmatched intraoperative flexibility as well as exclusive, clinically proven technologies.

7. zimmerbiomet.com zimmerbiomet.com/content/dam/zb-corporate/en/products/specialties/shoulder/comprehensive-total-shoulder-system/comprehensive-total-shoulder-system-early-clinical-outcomes.pdf

Comprehensive® Total Shoulder System Early Clinical ... At a minimum. 2-year follow-up, the authors found that their results were comparable to previous outcomes achieved with conventional length humeral components, ...

8. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf19/K193373.pdf

Biomet Inc. April 15, 2020 Kari Hovorka Regulatory Affairs ... The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and ...