Comparing two reverse shoulder replacement implants for people needing shoulder joint replacement
Compares a stemless shoulder implant with a standard one in people needing shoulder replacement.
Key facts
- Who runs it
- Limacorporate S.p.a
- Where
- Boca Raton, Chicago, Denver, Durham, East Syracuse, Fishers, Los Angeles, Orlando, Philadelphia, San Antonio, Sayre, and Tampa, United StatesSee the 13 sites
- Trial code
- Registry title
- SMR Stemless Reverse vs SMR Reverse Shoulder System
- Status
- Recruiting
- People taking part
- 200 people, planned
- Started
- 1 Apr 2021
- Expected to end
- 30 Dec 2028
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Investigational Arm: SMR Stemless Reverse
- Control Arm: SMR Reverse Shoulder System
- Record updated
- 28 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who need a first total reverse shoulder replacement. Their shoulder must have a badly damaged rotator cuff and severe joint disease. They must still have strong symptoms after non-surgical treatment.
- Age
- 22 years or older.
- Sex
- All sexes.
- Disease stage
- Severe shoulder joint disease (disabled shoulder) with major rotator cuff damage. Examples: a rotator cuff tear that cannot be repaired, arthritis with such a tear, rotator cuff tear arthropathy, severe osteoarthritis with a stiff shoulder, bone loss or deformity of the shoulder socket, or a shoulder that keeps dislocating. Bones must be fully grown.
- Earlier treatment
- Symptoms must continue despite non-surgical treatment. This must be a first (primary) shoulder replacement. No surgery on the treated shoulder in the last 12 months, except a diagnostic arthroscopy with no procedures. No steroid injections in that shoulder in the last 3 months.
Main reasons for not taking part
- BMI over 40 kg/m2.
- Surgery on the other shoulder within 3 months, or hip or knee surgery within 6 months.
- Complete weakness of the deltoid muscle, or a nerve injury that harms shoulder function.
- Current or past infection in the body or bone.
- Weak or missing bone that could make the implant unstable, such as severe osteoporosis, a large cyst, or uncontrolled diabetes with HbA1C > 7.5% (58 mmol/mol).
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- Age ≥ 22 years of age
- Skeletally mature as evident by scapula and proximal humerus closure
- 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:; Arthritis with rotator cuff tear not reparable; Irreparable rotator cuff tear; Rotator cuff tear arthropathy; Severe osteoarthritis and rotator cuff deficiency or stiff shoulder; Significant glenoid or socket side bone deformed or loss; Reoccurrence of instability or a chronic shoulder dislocation; Any other medical reason that the investigator determine that subject is a good candidate for a reverse total shoulder arthroplasty
Who cannot take part
- Previous contralateral shoulder surgery within 3 months of enrollment or that requires active treatment (i.e. surgery or brace)
- Had surgery in the targeted shoulder within last 12 months of enrollment, except diagnostic arthroscopy without procedures
- Had surgery in lower limbs (such as hip or knee) within last 6 months of enrollment
- Corticosteroid injections in the ipsilateral shoulder within 3 months of enrollment
- Poor meta-epiphyseal bone stock compromising stability of the implant including but not limited to humeral head fracture, iatrogenic glenoid fracture, severe osteoporosis
- Extended bone loss after previous surgery defined as: complete bone loss of greater and lesser tuberosity
- Complete deltoid muscle insufficiency
- History of/or signs and/or symptoms of local or systemic infection including but not limited to septicemia; osteomyelitis
- Metabolic disorders which may impair fixation and stability of the implant including but not limited to uncontrolled diabetes mellitus with an HbA1C > 7.5%
- BMI > 40 kg/m2
- Glenoid retroversion great than 25 degrees based off a 2D axial CT scan
- Neurologically confirmed nerve lesion compromising shoulder joint function
- Meta-epiphyseal bony defect (including large cyst)
Where in United States
- Levy Shoulder CenterBoca Raton, United StatesContact: Janice SchuckTaking people
- Rush OrthopaedicsChicago, United StatesContact: Fabiana PavanNo longer taking part
- Western OrthopaedicsDenver, United StatesContact: Fabiana PavanNo longer taking part
- Duke UniversityDurham, United StatesContact: Fabiana PavanNo longer taking part
- Upstate OrthopedicsEast Syracuse, United StatesContact: Tina CraigTaking people
- Central Indiana OrthopedicsFishers, United StatesContact: Brad CrackelTaking people
- Cedars-Sinai Kerlan-Jobe InstituteLos Angeles, United StatesContact: Fabiana PavanNo longer taking part
- AdventHealthOrlando, United StatesContact: Carissa DavyTaking people
- Rothman OrthopaedicPhiladelphia, United StatesContact: Thema NicolsonTaking people
- University of PennsylvaniaPhiladelphia, United StatesContact: Fabiana PavanNo longer taking part
- University of Texas Health Science CenterSan Antonio, United StatesContact: Fabiana PavanNo longer taking part
- GuthrieSayre, United StatesContact: Brent BloomquistTaking people
- Foundation For Orthopaedic Research and EducationTampa, United StatesContact: Debbi Warren, RN, CCRC, ACRP-CPTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- SMR Stemless ReverseTreatment being tested
Treatment: Investigational Arm: SMR Stemless Reverse
- SMR Reverse Shoulder SystemExisting treatment, for comparison
Treatment: Control Arm: SMR Reverse Shoulder System
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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
- Plain-language title
- Comparing two reverse shoulder replacement implants for people needing shoulder joint replacementGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Record updated
- 28 October 2026