Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
200 participants
INTERVENTIONAL
2021-04-01
2026-03-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Clinical Study Evaluating Outcomes of Reverse Shoulder Arthroplasty With SMR Stemless
NCT04529798
Study of Zimmer Biomet Mymobility Application on Reverse Total Shoulder Arthroplasty (RTSA) Outcomes
NCT05789784
SMR Stemless Shoulder Arthroplasty Clinical Study
NCT02679352
S-33 SMR Shoulder HP Reverse Glenosphere
NCT05339815
Post-Market Study of Comprehensive Reverse Augmented Glenoid and Mini Humeral Tray in Total Shoulder Arthroplasty
NCT03726554
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
SMR Stemless Reverse
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.
SMR Reverse Shoulder System
Control Arm: SMR Reverse Shoulder System
Conventional stemmed shoulder prostheses are commonly used in the clinical practice.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Control Arm: SMR Reverse Shoulder System
Conventional stemmed shoulder prostheses are commonly used in the clinical practice.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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)
22 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
NAMSA
OTHER
Limacorporate S.p.a
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Grant Garrigues, M.D.
Role: PRINCIPAL_INVESTIGATOR
Rush Orthopedics
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cedars-Sinai Kerlan-Jobe Institute
Los Angeles, California, United States
Western Orthopaedics
Denver, Colorado, United States
Levy Shoulder Center
Boca Raton, Florida, United States
AdventHealth
Orlando, Florida, United States
Rush Orthopaedics
Chicago, Illinois, United States
Upstate Orthopedics
East Syracuse, New York, United States
Duke University
Durham, North Carolina, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Rothman Orthopaedic
Philadelphia, Pennsylvania, United States
Guthrie
Sayre, Pennsylvania, United States
University of Texas- Health Science Center
San Antonio, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Janice Schuck
Role: primary
Jonathan Levy, MD
Role: backup
George Huffman, MD
Role: backup
Grant Garrigues, MD
Role: backup
Gregory Nicholson, MD
Role: backup
Brian Cole, MD
Role: backup
Nikhil Verma, MD
Role: backup
Kevin Setter, MD
Role: backup
Joseph Abboud, MD
Role: backup
Joseph Choi, MD
Role: backup
Ruby Samuel
Role: primary
Anil Dutta, MD
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
S-34
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.