Comparing two shoulder replacement systems for joint pain relief
A Randomized, Multi-Center, Prospective, Safety and Efficacy Study Comparing the Outcome of Total Reverse Shoulder Arthroplasty (RSA) with SMR Stemless Reverse Vs SMR Reverse Shoulder System
This study is testing a new shoulder replacement system to see if it can relieve pain and improve shoulder function just as well as the traditional system for people with shoulder issues.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | Limacorporate S.p.a Industry-sponsored |
| Locations | 11 sites (Los Angeles, California and 10 other locations) |
| Trial ID | NCT04697004 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of the SMR Stemless Reverse shoulder replacement system against the traditional SMR Reverse Shoulder System. It is a prospective, multi-center, randomized, controlled trial designed to demonstrate that the new stemless system is not inferior to the established system in terms of pain relief and restoration of shoulder function. Eligible patients will be randomized into one of the two groups after meeting specific inclusion criteria and signing an informed consent form. The trial is expected to enroll participants over a period of 24 months.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 22 and older with severe shoulder joint dysfunction due to conditions like rotator cuff tears or severe osteoarthritis.
Not a fit: Patients with a BMI over 40 kg/m2 or those who have had recent shoulder surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide patients with a less invasive shoulder replacement option that offers similar or improved outcomes.
How similar studies have performed: Other studies have shown promising results with similar shoulder replacement approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥ 22 years of age 2. Skeletally mature as evident by scapula and proximal humerus closure 3. Candidate for primary total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy (disabled shoulder), when clinical indications based on physical exam and medical history including one or more of the following: 1. Arthritis with rotator cuff tear not reparable 2. Irreparable rotator cuff tear 3. Rotator cuff tear arthropathy 4. Severe osteoarthritis and rotator cuff deficiency or stiff shoulder 5. Significant glenoid or socket side bone deformed or loss 6. Reoccurrence of instability or a chronic shoulder dislocation 7. Any other medical reason that the investigator determine that subject is a good candidate for a reverse total shoulder arthroplasty Exclusion Criteria: 1. BMI \> 40 kg/m2 2. Previous contralateral shoulder surgery within 3 months of enrollment or that requires active treatment (i.e. surgery or brace) 3. Had surgery in the targeted shoulder within last 12 months of enrollment, except diagnostic arthroscopy without procedures 4. Had surgery in lower limbs (such as hip or knee) within last 6 months of enrollment 5. Corticosteroid injections in the ipsilateral shoulder within 3 months of enrollment 6. Complete deltoid muscle insufficiency 7. Glenoid retroversion great than 25 degrees based off a 2D axial CT scan 8. History of/or signs and/or symptoms of local or systemic infection including but not limited to septicemia; osteomyelitis 9. Neurologically confirmed nerve lesion compromising shoulder joint function 10. Poor meta-epiphyseal bone stock compromising stability of the implant including but not limited to humeral head fracture, iatrogenic glenoid fracture, severe osteoporosis 11. Metabolic disorders which may impair fixation and stability of the implant including but not limited to uncontrolled diabetes mellitus with an HbA1C \> 7.5% 12. Extended bone loss after previous surgery defined as: complete bone loss of greater and lesser tuberosity 13. Meta-epiphyseal bony defect (including large cyst)
Where this trial is running
Los Angeles, California and 10 other locations
- Cedars-Sinai Kerlan-Jobe Institute — Los Angeles, California, United States (Withdrawn)
- Western Orthopaedics — Denver, Colorado, United States (Active_not_recruiting)
- Levy Shoulder Center — Boca Raton, Florida, United States (Recruiting)
- AdventHealth — Orlando, Florida, United States (Recruiting)
- Rush Orthopaedics — Chicago, Illinois, United States (Recruiting)
- Upstate Orthopedics — East Syracuse, New York, United States (Recruiting)
- Duke University — Durham, North Carolina, United States (Active_not_recruiting)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Withdrawn)
- Rothman Orthopaedic — Philadelphia, Pennsylvania, United States (Recruiting)
- Guthrie — Sayre, Pennsylvania, United States (Recruiting)
- University of Texas- Health Science Center — San Antonio, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Grant Garrigues, M.D. — Rush Orthopedics
- Study coordinator: Fabiana Pavan
- Email: Fabiana.Pavan@limacorporate.com
- Phone: +39 348 5816391
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.