Shoulder Implant for Arthritis

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

102 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is a multicenter, prospective, non-randomized, non-controlled, dual cohort post market surveillance study. The primary objective of this study is to confirm the safety and performance of the Comprehensive Reverse Shoulder System when used with the Comprehensive Porous Augmented Glenoid Baseplate and/or Comprehensive Mini Humeral Tray in primary and revision reverse shoulder arthroplasty.

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 data supports the effectiveness of the treatment Comprehensive Mini Humeral Tray, Comprehensive Reverse Augmented Glenoid for shoulder arthritis?

Research suggests that using a custom metal glenoid implant in reverse total shoulder arthroplasty (a type of shoulder surgery) can help address severe bone loss, which is a common issue in shoulder arthritis. Additionally, the placement of the humeral tray (part of the shoulder implant) can influence shoulder movement and muscle function, potentially improving outcomes for patients. ^{1 2 3 4 5}

Is the shoulder implant for arthritis generally safe for humans?

The shoulder implant, including versions like the Comprehensive Mini Humeral Tray and Comprehensive Reverse Augmented Glenoid, has been studied in various forms. Some studies report complications such as infections, nerve issues, and implant loosening, but also show good short- and medium-term results. Design improvements have reduced some early issues, suggesting it is generally safe, though long-term data varies. ^{3 6 7 8 9}

How is the Comprehensive Mini Humeral Tray and Comprehensive Reverse Augmented Glenoid treatment unique for shoulder arthritis?

This treatment is unique because it uses a reverse shoulder arthroplasty approach with augmented glenoid baseplates, which can provide better outcomes for patients with glenoid deformities compared to traditional bone grafting methods. ^{2 3 10 11 12}

Research Team

Erin Osborn

Principal Investigator

Zimmer Biomet

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Reverse total shoulder glenoid component inclination affects glenohumeral kinetics during abduction: a cadaveric study. [2023]

2. China pubmed.ncbi.nlm.nih.gov

[RESEARCH DEVELOPMENT OF REVERSE TOTAL SHOULDER ARTHROPLASTY]. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Early results of reverse total shoulder arthroplasty using a patient-matched glenoid implant for severe glenoid bone deficiency. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Effect of humeral tray placement on impingement-free range of motion and muscle moment arms in reverse shoulder arthroplasty. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Management of glenoid bone loss in primary reverse shoulder arthroplasty : a systematic review and meta-analysis. [2022]

6. France pubmed.ncbi.nlm.nih.gov

New design of a cementless glenoid component in unconstrained shoulder arthroplasty: a prospective medium-term analysis of 143 cases. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Midterm results of a total shoulder prosthesis fixed with a cementless glenoid component. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Complications with reverse total shoulder arthroplasty and recent evolutions. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Influence of Glenosphere and baseplate parameters on Glenoid bone strains in reverse shoulder Arthroplasty. [2020]

10. Korea (South) pubmed.ncbi.nlm.nih.gov

Clinical and Radiologic Outcomes of Small Glenoid Baseplate in Reverse Total Shoulder Arthroplasty: A Prospective Multicenter Study. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Augmented baseplates yield optimum outcomes when compared with bone graft augmentation for managing glenoid deformity during reverse total shoulder arthroplasty: a retrospective comparative study. [2023]

12. Korea (South) pubmed.ncbi.nlm.nih.gov

Treatment of instability with scapular notching and glenoid component loosing by partial mixed different implant revision. [2020]