Shoulder Arthroplasty for Shoulder Conditions

Recruiting at 16 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and benefits of a new shoulder replacement system called the Zimmer Biomet Shoulder Arthroplasty System. It aims to assist individuals with shoulder joint issues, such as osteoarthritis (joint wear and tear) or rheumatoid arthritis (joint inflammation), who require shoulder replacement surgery. Participants should experience shoulder problems that impact daily life and are not well-managed by other treatments, including significant shoulder pain or a previous unsuccessful shoulder replacement. As an unphased trial, this study provides an opportunity to contribute to important research that could enhance shoulder replacement options for many patients.

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 prior data suggests that the Zimmer Biomet Shoulder Arthroplasty Systems and its instrumentation are safe?

Research has shown that the Zimmer Biomet Shoulder Arthroplasty Systems have been tested for safety and effectiveness in various settings. Specifically, the Sidus® Stem-Free Shoulder was deemed safe in a two-year study conducted in the US and Canada. This study found that patients generally tolerated the treatment well, with no major safety issues reported.

The Comprehensive® Total Shoulder System, designed for adaptability during surgery, has been used successfully in different situations. Early results suggest it is generally well-tolerated by patients, with most experiencing no serious side effects.

These findings provide some confidence in the safety of these systems for shoulder replacement surgeries. However, individual experiences may vary, so discussing any concerns with healthcare professionals is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Zimmer Biomet Total Shoulder Arthroplasty System because it offers a new level of precision and customization in shoulder replacement surgeries. Unlike traditional shoulder arthroplasty options, this system is designed with advanced instrumentation that allows for a more tailored fit to each patient's unique anatomy. This could lead to improved joint function and longevity of the implant, reducing the need for additional surgeries down the line. Additionally, the focus on both primary and revision surgeries broadens its applicability, potentially offering better outcomes for a wider range of patients.

What evidence suggests that the Zimmer Biomet Shoulder Arthroplasty Systems are effective for shoulder conditions?

Research has shown that the Zimmer Biomet Shoulder Arthroplasty Systems perform well in shoulder replacement surgeries. In this trial, participants will receive the Zimmer Biomet Total Shoulder Arthroplasty System. Studies have found that the Comprehensive® Total Shoulder System, part of the Zimmer Biomet systems, provides flexibility during surgery and offers options to meet different patient needs. This system is designed to help surgeons operate efficiently, potentially leading to better patient outcomes. Additionally, the Sidus Stem-Free Shoulder System, also part of the Zimmer Biomet systems, has been tested for safety and effectiveness in shoulder replacements. A study involving multiple centers found that this stemless system is a reliable choice for patients with good bone health, particularly those with conditions like osteoarthritis. Overall, these systems have demonstrated clinical benefits and are supported by positive early findings. ^{1 2 4 5 6}

Who Is on the Research Team?

Ryan Boylan

Principal Investigator

Zimmer Biomet

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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 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 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]

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]

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]

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]

Citations

1. 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 ... The Comprehensive® Total Shoulder System allows for surgeon efficiency through intraoperative flexibility, multiple humeral stem options and infinite humeral.

2. zimmerbiomet.com zimmerbiomet.com/content/dam/zimmer-biomet/medical-professionals/shoulder/sidus-stem-free-shoulder-system/sidus-stem-free-shoulder-surgical-technique.pdf

Sidus Stem-Free Shoulder Surgical Technique Sidus Shoulder is a total shoulder arthroplasty solution for patients with good bone stock that have either osteoarthritis, posttraumatic arthrosis, focal ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2468602619300567

A multicenter, prospective 2-year analysis of the Sidus ... The purpose of this multicenter, prospective study was to evaluate the efficacy and safety of a stemless total shoulder arthroplasty compared with a ...

4. zimmerbiomet.com zimmerbiomet.com/en/products-and-solutions/specialties/shoulder/comprehensive-total-shoulder-system.html

Comprehensive® Total Shoulder System The system uses innovative technologies to allow intraoperative flexibility, unmatched humeral stem options, and infinite humeral head offset possibilities.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT01878253

NCT01878253 | Sidus Stem-Free Shoulder IDE Study The purpose of this study is to determine if Sidus stem-free shoulder system is safe and effective when used in total shoulder replacement.

6. zimmerbiomet.com zimmerbiomet.com/en/products-and-solutions/specialties/shoulder/sidus-stem-free-shoulder.html

Sidus® Stem-Free Shoulder The Sidus System has demonstrated continued success with clinical data from a two year IDE study in the US and Canada1. The studies targeted patients with good ...