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Joint Replacement

Stemless vs Standard Shoulder Replacement for Joint Dysfunction

N/A
Recruiting
Led By Grant Garrigues, M.D.
Research Sponsored by Limacorporate S.p.a
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 22 years of age
Rotator cuff tear arthropathy
Must not have
Corticosteroid injections in the ipsilateral shoulder within 3 months of enrollment
Meta-epiphyseal bony defect (including large cyst)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 6, 12 and 24 month visits
Awards & highlights
No Placebo-Only Group

Summary

This trial is designed to show that the SMR Stemless Reverse is non-inferior to the SMR Reverse Shoulder System for the treatment of shoulder joint dysfunction.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed here, typical risks from shoulder replacement surgery may include infection, nerve damage, blood clots, implant loosening or wear, persistent pain, and complications from anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 22 years old or older.
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I have shoulder damage due to a tendon tear.
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I have significant bone loss or deformity in my shoulder socket.
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My bones are fully grown.
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I have severe joint pain and shoulder issues.
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My shoulder keeps dislocating or feels unstable again.
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I have arthritis and an unfixable tear in my shoulder muscle.
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I have a rotator cuff tear that cannot be fixed.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't had corticosteroid injections in my shoulder in the last 3 months.
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I have a large bone cyst or defect near the end of a bone.
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I have not had shoulder surgery on the opposite side within the last 3 months nor require active treatment for it.
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I had surgery on my leg or hip in the last 6 months.
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My shoulder muscle is completely weak or not working.
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I have a nerve injury affecting my shoulder movement.
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My diabetes is controlled, with an HbA1C of 7.5% or lower.
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I have no history or current signs of serious infections like septicemia or bone infection.
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I have weak shoulder bones that may affect the stability of an implant.
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I have lost all bone in specific areas of my shoulder after surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 6, 12 and 24 month visits
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6, 12 and 24 month visits for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Primary Efficacy Endpoint-Constant Murley Score
Primary Safety Endpoint-Absence of revisions, reoperations, and implant loosening.
Secondary study objectives
Elbow
Secondary Efficacy Measure-Constant-Murley Score
Secondary Efficacy Measure-EQ-5D-5L
+6 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: SMR Stemless ReverseExperimental Treatment1 Intervention
Group II: SMR Reverse Shoulder SystemActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Limacorporate S.p.aLead Sponsor
26 Previous Clinical Trials
2,884 Total Patients Enrolled
NAMSAOTHER
52 Previous Clinical Trials
20,623 Total Patients Enrolled
Grant Garrigues, M.D.Principal InvestigatorRush Orthopedics

Media Library

SMR Reverse Shoulder System (Joint Replacement) Clinical Trial Eligibility Overview. Trial Name: NCT04697004 — N/A
Joint Replacement Research Study Groups: SMR Stemless Reverse, SMR Reverse Shoulder System
Joint Replacement Clinical Trial 2023: SMR Reverse Shoulder System Highlights & Side Effects. Trial Name: NCT04697004 — N/A
SMR Reverse Shoulder System (Joint Replacement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04697004 — N/A
~51 spots leftby Mar 2026
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