Comparing two shoulder replacement systems for joint pain relief

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Levy Shoulder Center
  Boca Raton, Florida, United States Recruiting
• AdventHealth
  Orlando, Florida, United States Recruiting
• Foundation for Orthopaedic Research and Education
  Tampa, Florida, United States Recruiting
• Central Indiana Orthopedics
  Fishers, Indiana, United States Recruiting
• Upstate Orthopedics
  East Syracuse, New York, United States Recruiting
• Rothman Orthopaedic
  Philadelphia, Pennsylvania, 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.