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

Trial Summary

What is the purpose of this trial?

The SMR Stemless Reverse is intended for total, primary shoulder joint replacement by reducing pain and restoring shoulder articular mobility function. This is a prospective, multi-center, randomized, controlled trial to demonstrate non-inferiority of the SMR Stemless Reverse to the SMR Reverse Shoulder System. Patients with joint dysfunction who continue to experience significant symptoms despite an appropriate course of non-operative management are eligible. Patients will be considered enrolled into the study when an ICF has been signed, all inclusion criteria are met and no exclusion criteria are present including intraoperative exclusion criteria, and the patient is randomized into either the SMR Stemless Reverse (investigational) group, the SMR Reverse Shoulder System (control) group or is part of the roll-in population. Enrollment is expected to take approximately 24 months.

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.

What data supports the effectiveness of the SMR Reverse Shoulder System treatment for joint dysfunction?

The SMR Reverse Shoulder System has shown positive results in a study involving 496 cases over 14 years, with significant improvements in shoulder function and pain reduction, and no implant failures or wear issues. This suggests it is effective for treating severe shoulder joint problems. ^{1 2 3 4 5}

Is the SMR Reverse Shoulder System safe for humans?

The SMR Reverse Shoulder System has been used in various studies with no reported implant failures or significant complications over several years, indicating it is generally safe for humans. ^{1 2 5 6 7}

How does the SMR Stemless Reverse Shoulder System treatment differ from other treatments for shoulder joint dysfunction?

The SMR Stemless Reverse Shoulder System is unique because it uses a stemless design, which can lead to fewer complications related to the shaft, preserve more bone, and make future surgeries easier. This system is modular, allowing for customization to fit the patient's anatomy, and has shown promising results in terms of improved shoulder function and reduced pain. ^{2 4 5 6 7}

Research Team

Grant Garrigues, MD

Principal Investigator

Rush Orthopedics

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. Germany 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. [2019]

2. Czech Republic pubmed.ncbi.nlm.nih.gov

Reverse Total Shoulder Arthroplasty: 14-Year Clinical Experience with 496 Performed Arthroplasties. [2022]

3. Iran pubmed.ncbi.nlm.nih.gov

The Midterm Results of the Delta Xtend Reverse Shoulder System: A Five-Year Outcome Study. [2022]

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

Comparison of stemless and conventional stemmed shoulder arthroplasties in shoulder arthropathy: A meta-analysis. [2023]

5. Germany pubmed.ncbi.nlm.nih.gov

Conversion of shoulder arthroplasty to reverse implants: clinical and radiological results using a modular system. [2021]

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

Stemless Reverse Shoulder Arthroplasty. [2023]

7. Czech Republic pubmed.ncbi.nlm.nih.gov

Stemless Hemiarthroplasty of the Shoulder Using the SMR® System: Summary of Six-Year Experience and Surgical Technique. [2023]