Shoulder Arthroplasty for Shoulder Conditions

Recruiting at 14 trial locations

Overseen By Cayla Lafollette, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Zimmer Biomet

Disqualifiers: Pregnancy, Osteoporosis, Neuromuscular disease, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Surgery and immediate post-operative period

584 Participants Needed

Trial Summary

What is the purpose of this trial?

The objectives of this study are to confirm the safety, performance, and clinical benefits of Zimmer Biomet Shoulder Arthroplasty Systems and its instrumentation in primary or revision shoulder arthroplasty. These objectives will be assessed using standard scoring systems, radiographic evidence, and adverse event records. Safety of the system will be assessed by monitoring the frequency an incidence of adverse events.

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 team or your doctor.

What data supports the effectiveness of the Zimmer Biomet Shoulder Arthroplasty Systems treatment?

Research shows that the Zimmer Biomet glenoid vault reconstruction system (VRS) used in reverse shoulder arthroplasty has acceptable short-term outcomes and complication rates. Additionally, the TESS stemless shoulder prosthesis, which is part of the Zimmer Biomet systems, has shown maintained fixation and stability after three years, indicating its effectiveness in shoulder arthroplasty. ^{1 2 3 4 5}

Is shoulder arthroplasty generally safe for humans?

Research indicates that stemless shoulder arthroplasty systems, like the TESS and other similar implants, have evolved to reduce complications such as osteolysis (bone loss), stress shielding, and periprosthetic fractures (fractures around the implant). These systems are considered safe and effective, with improvements in fixation and stability over time. ^{2 4 5 6 7}

What makes the Zimmer Biomet Shoulder Arthroplasty Systems treatment unique for shoulder conditions?

The Zimmer Biomet Shoulder Arthroplasty Systems offer a modular design that allows for precise anatomical reconstruction of the shoulder joint, which can be tailored to individual patient needs. This system includes options like the stem-free shoulder, which avoids complications associated with traditional stemmed implants, making it a novel choice compared to standard shoulder arthroplasty treatments. ^{1 3 5 8 9}

Research Team

Ryan Boylan

Principal Investigator

Zimmer Biomet

Eligibility Criteria

This trial is for adults over 20 with shoulder issues like arthritis, fractures, or deformities who need a shoulder replacement and have a working deltoid muscle. It's not for those with neuromuscular diseases affecting the limb, severe bone conditions, infections near the joint, pregnant or breastfeeding women, vulnerable populations, or anyone unable to follow the study protocol.

Inclusion Criteria

Patient must be able and willing to sign the IRB/EC approved informed consent

I am 20 years old or older.

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

Exclusion Criteria

I have a significant shoulder injury or muscle paralysis.

I have a bone condition like osteoporosis or a metabolic disorder affecting my bones.

I have an infection near my shoulder that could affect a surgery site.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Zimmer Biomet Shoulder Arthroplasty System in primary or revision shoulder arthroplasty

Surgery and immediate post-operative period

Follow-up

Participants are monitored for safety and effectiveness after treatment, including radiographic evaluations and clinical assessments

2 years

Regular follow-up visits for radiographic and clinical assessments

Long-term Follow-up

Participants are monitored for implant survivorship and adverse events over a long-term period

10 years

Treatment Details

Interventions

• Zimmer Biomet Shoulder Arthroplasty Systems
• Zimmer Biomet Shoulder Arthroplasty Systems Instrumentation

Trial Overview The trial tests Zimmer Biomet Shoulder Arthroplasty Systems in patients needing new shoulders (primary) or replacements (revision). It checks if these implants are safe and work well by looking at patient scores on standard health scales, X-rays of their shoulders before and after surgery, and tracking any complications.

Participant Groups

Group I: Zimmer Biomet Total Shoulder Arthroplasty System Experimental Treatment 2 Interventions

Patients who are having primary or revision total shoulder arthroplasty who will receive a Zimmer Biomet Total Shoulder Arthroplasty System.

Zimmer Biomet Shoulder Arthroplasty Systems is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Sidus Stem-Free Shoulder for:

• Osteoarthritis
• Posttraumatic arthrosis
• Focal avascular necrosis of the humeral head
• Previous surgeries of the shoulder that do not compromise the fixation

Approved in United States as Comprehensive Total Shoulder System for:

• Osteoarthritis
• Fracture
• Rotator cuff arthropathy
• Other non-inflammatory shoulder issues

Approved in Canada as Sidus Stem-Free Shoulder for:

• Osteoarthritis
• Posttraumatic arthrosis
• Focal avascular necrosis of the humeral head
• Previous surgeries of the shoulder that do not compromise the fixation

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 UNIVERS 3-D prosthesis significantly improved shoulder function in 74 patients with glenohumeral osteoarthritis, with Constant scores increasing from 34.1 to 68.4 points after an average follow-up of 31.9 months.

The procedure demonstrated a low complication rate of 12.2% and a minimal incidence of radiolucent lines around the prosthesis, indicating both safety and efficacy in reconstructing shoulder anatomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical outcomes of treatment of glenohumeral osteoarthritis with new generation shoulder prosthesis]. Tang, KL., Li, QH., Habermeyer, P.[2016]

In a study of 12 shoulders (11 patients) undergoing reverse shoulder arthroplasty with the custom glenoid vault reconstruction system (VRS), significant improvements were observed in pain and shoulder function scores after an average follow-up of 30 months, indicating its efficacy for complex glenoid deformities.

All implants remained stable without any complications, suggesting that the VRS technique is a safe option for both primary and revision shoulder arthroplasties.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term outcomes of reverse shoulder arthroplasty using a custom baseplate for severe glenoid deficiency. Bodendorfer, BM., Loughran, GJ., Looney, AM., et al.[2021]

The modern cup arthroplasty system offers significant advantages over traditional humeral shaft arthroplasty, including the ability to avoid mandatory humeral head resection and the option to convert to a standard prosthesis if needed.

In a clinical trial involving 14 patients, the cup system demonstrated a notable improvement in shoulder function, with the Constant-Score increasing from an average of 23 to 55 points over a mean follow-up period of 6.1 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Total shoulder arthroplasty vs. hemiarthroplasty]. Arman, F.[2016]

In a study of 70 patients who received the TESS stemless humeral prosthesis, significant improvements in shoulder mobility were observed, with an average increase of 49 degrees in forward flexion and 20 degrees in external rotation after more than 3 years of follow-up.

Radiographic analysis showed no signs of implant migration or complications, indicating that the stemless design can achieve stable anatomical reconstruction of the proximal humerus, comparable to traditional prosthetic replacements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of a new stemless shoulder prosthesis: radiologic proof of maintained fixation and stability after a minimum of three years' follow-up. Huguet, D., DeClercq, G., Rio, B., et al.[2016]

The evolution of shoulder prostheses has led to a decrease in overall complication rates due to improved anatomic design, but there has been an increase in periprosthetic humeral fractures.

The stemless total evolutive shoulder system has been developed to minimize stem-related complications while maintaining the benefits of modern shoulder implants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placement of the stemless humeral component in the Total Evolutive Shoulder System (TESS). Geurts, GF., van Riet, RP., Jansen, N., et al.[2010]

Stemless total shoulder arthroplasty (TSA) is a safe and effective option for patients with shoulder issues, preserving bone stock and reducing complications like osteolysis and periprosthetic fractures.

As the incidence of TSA is expected to rise significantly, stemless implants are becoming increasingly popular due to their ability to improve anatomic reconstruction and biomechanical function of the shoulder joint.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stemless Total Shoulder: A Review of Biomechanical Fixation and Recent Results. Wodarek, J., Shields, E.[2023]

The custom-made CAD-CAM total shoulder replacement (TSR) significantly reduced pain levels and improved shoulder function in 37 patients with severe glenoid bone loss over a mean follow-up of 5 years, demonstrating its efficacy as a treatment option.

Despite a 16% revision rate due to complications like glenoid loosening and dislocation, the CAD-CAM TSR provided substantial clinical benefits, making it a reliable alternative for patients not suitable for standard shoulder implants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary shoulder arthroplasty using a custom-made hip-inspired implant for the treatment of advanced glenohumeral arthritis in the presence of severe glenoid bone loss. Chammaa, R., Uri, O., Lambert, S.[2018]

Shoulder arthroplasty is a versatile surgical option for various conditions, including osteoarthritis, and requires tailored approaches and implants for different indications.

The third generation of shoulder prostheses allows for precise reconstruction of the shoulder joint's anatomy, improving the centering of the glenohumeral joint during implantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Shoulder Arthroplasty. Surgical management]. Habermeyer, P., Lichtenberg, S., Magosch, P.[2021]

Reverse total shoulder arthroplasty (RTSA) has become more popular than total shoulder arthroplasty (TSA) in the U.S., with lower surgical complication rates for patients over 50 years old (2.25% for RTSA vs. 3.94% for TSA).

Patients with a history of tobacco use, depression, and obesity are at higher risk for complications, highlighting the importance of considering these factors when evaluating surgical options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical Complications After Reverse Total Shoulder Arthroplasty and Total Shoulder Arthroplasty in the United States. Ma, GC., Bradley, KE., Jansson, H., et al.[2021]

References

1. China pubmed.ncbi.nlm.nih.gov

[Clinical outcomes of treatment of glenohumeral osteoarthritis with new generation shoulder prosthesis]. [2016]

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

Short-term outcomes of reverse shoulder arthroplasty using a custom baseplate for severe glenoid deficiency. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

[Total shoulder arthroplasty vs. hemiarthroplasty]. [2016]

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

Results of a new stemless shoulder prosthesis: radiologic proof of maintained fixation and stability after a minimum of three years' follow-up. [2016]

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

Placement of the stemless humeral component in the Total Evolutive Shoulder System (TESS). [2010]

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

Stemless Total Shoulder: A Review of Biomechanical Fixation and Recent Results. [2023]

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

Primary shoulder arthroplasty using a custom-made hip-inspired implant for the treatment of advanced glenohumeral arthritis in the presence of severe glenoid bone loss. [2018]

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

[Shoulder Arthroplasty. Surgical management]. [2021]

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

Surgical Complications After Reverse Total Shoulder Arthroplasty and Total Shoulder Arthroplasty in the United States. [2021]