SMR Stemless Reverse vs SMR Reverse Shoulder System

Study Purpose

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. 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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	22 Years and Over
Gender	All

More 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)

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04697004
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Limacorporate S.p.a
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Grant Garrigues, M.D.
Principal Investigator Affiliation	Rush Orthopedics
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry, Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Arthroplasty, Replacement

Arms & Interventions

Arms

Experimental: SMR Stemless Reverse

Active Comparator: SMR Reverse Shoulder System

Interventions

Device: - Investigational Arm: SMR Stemless Reverse

The SMR Stemless Reverse is intended for total, primary shoulder joint replacement by reducing pain and restoring shoulder articular mobility function.

Device: - Control Arm: SMR Reverse Shoulder System

Conventional stemmed shoulder prostheses are commonly used in the clinical practice.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Cedars-Sinai Kerlan-Jobe Institute, Los Angeles, California

Status

Withdrawn

Address

Cedars-Sinai Kerlan-Jobe Institute

Los Angeles, California, 90045

Site Contact

[email protected]

+39 348 5816391

Western Orthopaedics, Denver, Colorado

Status

Active, not recruiting