Stemless vs Standard Shoulder Replacement for Joint Dysfunction

Recruiting at 8 trial locations

Overseen By Tory Sears

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Limacorporate S.p.a

Must not be taking: Corticosteroids

Disqualifiers: BMI > 40, Recent shoulder surgery, Others

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

Compensation: Varies

Number of Visits: 6

Duration: 24 months

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two shoulder replacement treatments to determine if the new stemless version, the SMR Stemless Reverse Shoulder System, matches the standard SMR Reverse Shoulder System in reducing pain and improving shoulder movement. It targets individuals with serious shoulder joint issues, such as severe arthritis or an irreparable rotator cuff tear. Those who have not found relief with non-surgical treatments might be suitable for this study. Participants will be randomly assigned to receive either the stemless or standard shoulder replacement to compare effectiveness. As an unphased trial, this study provides patients with the opportunity to explore innovative treatment options that could enhance their quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have had corticosteroid injections in the shoulder within the last 3 months, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the SMR Stemless Reverse shoulder system is generally well-tolerated. One study found that 13.4% of patients experienced complications, and 5.5% required additional surgery. These rates are similar to those of traditional shoulder implants.

For those considering the SMR Reverse Shoulder System, it is important to know that this trial compares it as a well-established option. Both treatments aim to reduce pain and improve shoulder movement.

Although these numbers might seem technical, they indicate that the stemless option has been studied and found to be as safe as other commonly used shoulder implants. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Most shoulder replacements involve a standard prosthetic with a long stem inserted into the arm bone, which can be invasive and require significant bone removal. The SMR Stemless Reverse is unique because it eliminates the need for this long stem, potentially preserving more of the patient's natural bone. This could lead to quicker recovery times and less post-surgery pain. Researchers are excited about this treatment because it offers a less invasive option compared to traditional shoulder replacements, which might improve patient outcomes and satisfaction. Meanwhile, the SMR Reverse Shoulder System serves as a comparator, representing the current standard approach that utilizes a stemmed implant.

What evidence suggests that this trial's treatments could be effective for joint dysfunction?

Research has shown that the SMR Stemless Reverse shoulder replacement, one of the treatments studied in this trial, performs as well as traditional shoulder implants with stems. Patients using this stemless system reported less pain and improved shoulder movement. This treatment also preserves more bone and may result in fewer complications. The aim is for it to match the effectiveness of the regular SMR Reverse Shoulder System, another treatment option in this trial and a trusted choice for shoulder replacement. Early results suggest the stemless option could be a strong alternative for those seeking shoulder joint relief. ^{1 2 3 5 6}

Who Is on the Research Team?

Grant Garrigues, MD

Principal Investigator

Rush Orthopedics

Are You a Good Fit for This Trial?

This trial is for adults over 22 years old needing a primary total shoulder replacement due to severe joint issues like rotator cuff tear arthropathy or osteoarthritis. Candidates must have tried non-surgical treatments without relief. Exclusions include obesity (BMI > 40), certain bone and metabolic conditions, recent surgeries on the same or opposite shoulder, and systemic infections.

Inclusion Criteria

I am 22 years old or older.

I have shoulder damage due to a tendon tear.

I have significant bone loss or deformity in my shoulder socket.

Exclusion Criteria

I haven't had corticosteroid injections in my shoulder in the last 3 months.

I have not had shoulder surgery on the opposite side within the last 3 months nor require active treatment for it.

I have a large bone cyst or defect near the end of a bone.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo total reverse shoulder arthroplasty with either the SMR Stemless Reverse or SMR Reverse Shoulder System

24 months

3, 6, 12, and 24 month visits

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of implant loosening and quality of life measures

24 months

3, 6, 12, and 24 month visits

What Are the Treatments Tested in This Trial?

Interventions

• SMR Reverse Shoulder System
• SMR Stemless Reverse

Trial Overview The study compares two types of shoulder replacements: SMR Stemless Reverse (new investigational device) versus the standard SMR Reverse Shoulder System. It's designed to see if the new stemless system is just as good as the traditional one in reducing pain and improving mobility.

How Is the Trial Designed?

Group I: SMR Stemless Reverse Experimental Treatment 1 Intervention

Group II: SMR Reverse Shoulder System Active Control 1 Intervention

SMR Reverse Shoulder System is already approved in European Union, United States for the following indications:

Approved in European Union as SMR Reverse for:

• Primary osteoarthritis
• Cuff tear arthropathy
• Post-traumatic glenohumeral arthritis
• Chronic irreducible shoulder dislocation
• Revision surgery for failed anatomical total shoulder arthroplasty
• Revision surgery for failed proximal humerus hemiarthroplasty

Approved in United States as SMR Reverse for:

• Completely torn rotator cuff that cannot be repaired
• Cuff tear arthropathy
• Previous shoulder replacement that was unsuccessful
• Severe shoulder pain and difficulty lifting arm away from side or over head
• Complex fracture of the shoulder joint
• Chronic shoulder dislocation
• Tumor of the shoulder joint

Who Is Running the Clinical Trial?

Limacorporate S.p.a

Lead Sponsor

Trials

31

Recruited

3,300+

NAMSA

Collaborator

Trials

55

Recruited

21,500+

Published Research Related to This Trial

In a meta-analysis of 6 studies, patients with shoulder arthropathy who received stemless shoulder prostheses showed significantly greater postoperative range of motion compared to those with conventional stemmed prostheses.

However, there were no significant differences in postoperative constant scores or complication rates between the two types of prostheses, suggesting that while stemless prostheses may improve mobility, they do not lead to better overall clinical outcomes or safety profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of stemless and conventional stemmed shoulder arthroplasties in shoulder arthropathy: A meta-analysis. Shin, YS., Lee, WS., Won, JS.[2023]

The Delta Xtend Reverse Shoulder System has proven to be a reliable option for both primary and revision shoulder arthroplasty, with good to excellent functional outcomes reported five years post-surgery for 50 patients.

Radiographic analysis showed that most patients maintained adequate glenoid component positioning and experienced minimal scapular notching, indicating effective implant performance and stability over the mid-term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Midterm Results of the Delta Xtend Reverse Shoulder System: A Five-Year Outcome Study. Horneff, JG., Nicholson, TA., Namdari, S., et al.[2022]

Stemless reverse shoulder arthroplasty (RSA) has potential advantages such as fewer complications related to the shaft, better bone preservation, and easier revision surgeries, which could improve patient outcomes.

European studies indicate that certain stemless RSA designs show similar early and mid-term outcomes compared to traditional stemmed RSA implants, but long-term results and differences in design between European and U.S. trials need further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stemless Reverse Shoulder Arthroplasty. Luthringer, TA., Horneff, JG., Abboud, JA.[2023]

In a study of 20 patients who underwent SMR® stemless shoulder hemiarthroplasty for primary osteoarthritis, significant improvements were observed in shoulder function, with the mean Constant Score increasing from 41.7 preoperatively to 85.7 postoperatively over an average follow-up of 3 years.

No cases of implant loosening or failure were reported, indicating a high level of safety and efficacy for the SMR® stemless system in shoulder arthroplasty.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stemless Hemiarthroplasty of the Shoulder Using the SMR® System: Summary of Six-Year Experience and Surgical Technique. Pokorný, D., Fulín, P., Heřt, J., et al.[2023]

In a study of 26 patients who underwent shoulder arthroplasty revisions to reverse implants, the use of a modular shoulder replacement system allowed for successful revisions without the need to remove the humeral stem, leading to shorter surgery times and minimal blood loss.

Patients showed significant clinical improvement, with a Constant score of 47.88 and an EQ-VAS score increase from 40 to 70, indicating effective pain relief and enhanced range of motion after the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conversion of shoulder arthroplasty to reverse implants: clinical and radiological results using a modular system. Castagna, A., Delcogliano, M., de Caro, F., et al.[2021]

In a study of 496 reverse total shoulder arthroplasties (RSA) using the LimaCorporate SMR® system over 14 years, significant improvements were observed in shoulder function, with the Constant Score increasing from 26.9 to 71.9 and active elevation improving from 48.5° to 127.35° after surgery.

The SMR® system demonstrated excellent safety, with no implant failures or signs of wear in the UHMWPE components, and a low incidence of scapular notching at only 2.7%, attributed to the implant's modular design.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reverse Total Shoulder Arthroplasty: 14-Year Clinical Experience with 496 Performed Arthroplasties. Pokorný, D., Fulín, P., Heřt, J., et al.[2022]

In a study of 29 patients who underwent stemless reverse shoulder arthroplasty (RSA), no significant differences in clinical outcomes were found compared to 24 matched patients who received conventional stemmed RSA, suggesting that stemless RSA is equally effective.

While there was one case of dislocation in the stemless group, the incidence of scapular notching was lower compared to the stemmed group, indicating a potential safety advantage for stemless RSA in certain patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short to mid-term results of stemless reverse shoulder arthroplasty in a selected patient population compared to a matched control group with stem. Moroder, P., Ernstbrunner, L., Zweiger, C., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8569012/

Clinical and radiological outcomes of a stemless reverse ... At short-term follow-up, stemless reverse shoulder systems show comparable clinical and radiological outcomes compared to stemmed reverse implants in the ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04529798

Clinical Study Evaluating Outcomes of Reverse Shoulder ... The focus of this study is the evaluation on clinical, patient-reported and radiographical outcomes of SMR Stemless Reverse Shoulder Arthroplasty. There is ...

3. trialx.com trialx.com/clinical-trials/listings/222584/smr-stemless-reverse-vs-smr-reverse-shoulder-system/

SMR Stemless Reverse vs SMR Reverse Shoulder System The SMR Stemless Reverse is intended for total, primary shoulder joint replacement by reducing pain and restoring shoulder articular mobility ...

4. trials.arthritis.org trials.arthritis.org/trials/NCT04697004

SMR Stemless Reverse Vs SMR Reverse Shoulder System This is a prospective, multi-center, randomized, controlled trial to demonstrate non-inferiority of the SMR Stemless Reverse to the SMR Reverse Shoulder System.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2666639125001427

Stemless shoulder arthroplasty: what are the benefits? Stemless reverse total shoulder arthroplasty (slrTSA) shares benefits with its anatomic counterpart, including reduced complications, bone preservation, and ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2666639125000264

Review Article Stemless reverse total shoulder arthroplasty Across all 15 studies, comparative and noncomparative studies, overall complication rates for stemless rTSA stood at 13.4% and revision rates at 5.5%.