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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 6, 12 and 24 month visits
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3, 6, 12 and 24 month visits
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 6, 12 and 24 month visits
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Primary Efficacy Endpoint-Constant Murley Score
Primary Safety Endpoint-Absence of revisions, reoperations, and implant loosening.
Secondary outcome measures
Elbow
Secondary Efficacy Measure-Constant-Murley Score
Secondary Efficacy Measure-EQ-5D-5L
+6 moreTrial 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
45 Previous Clinical Trials
16,723 Total Patients Enrolled
Grant Garrigues, M.D.Principal InvestigatorRush Orthopedics
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 22 years old or older.I haven't had corticosteroid injections in my shoulder in the last 3 months.I have shoulder damage due to a tendon tear.I have significant bone loss or deformity in my shoulder socket.My doctor thinks I am a good candidate for shoulder replacement surgery.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.My bones are fully grown.I had surgery on my leg or hip in the last 6 months.My shoulder muscle is completely weak or not working.I have a nerve injury affecting my shoulder movement.My diabetes is controlled, with an HbA1C of 7.5% or lower.I have severe joint pain and shoulder issues.I have no history or current signs of serious infections like septicemia or bone infection.I am a candidate for shoulder replacement due to severe joint issues.My shoulder keeps dislocating or feels unstable again.I have arthritis and an unfixable tear in my shoulder muscle.I have weak shoulder bones that may affect the stability of an implant.Your body mass index (BMI) is higher than 40, which means you are severely overweight.I have not had shoulder surgery in the last year, except for a diagnostic look inside the joint.I have lost all bone in specific areas of my shoulder after surgery.I have a rotator cuff tear that cannot be fixed.
Research Study Groups:
This trial has the following groups:- Group 1: SMR Stemless Reverse
- Group 2: SMR Reverse Shoulder System
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has this clinical trial been disseminated to multiple health care centers in the city?
"The trial is currently enrolling patients from Cedars-Sinai Kerlan-Jobe Institute in Los Angeles, Duke University in Durham and the University of Texas - Health Science Center in San Antonio. In addition to these sites, there are 8 other locations partaking in this clinical study."
Answered by AI
Are there any vacancies in this clinical trial for individuals seeking treatment?
"According to clinicaltrials.gov, this medical trial is actively recruiting patients. It was listed on April 1st 2021 and the information has been refreshed as recently as December 17th 2021."
Answered by AI
What results is this trial designed to produce?
"This 24 month long clinical trial strives to ascertain the efficacy of a proposed intervention through the evaluation of its primary endpoint, namely the Constant Murley Score. The secondary outcomes include further analysis of Constant-Murley and Simple Shoulder Test scores as well as an absence of subsequent surgical interventions such as removals or supplemental fixations."
Answered by AI
How many individuals are currently enrolled in this research endeavor?
"This clinical trial necessitates the enrollment of 200 participants that meet its eligibility criteria. Locations for this research include Cedars-Sinai Kerlan-Jobe Institute in Los Angeles, CA and Duke University in Durham, NC."
Answered by AI
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