SMR Stemless Reverse Vs SMR Reverse Shoulder System
Public ClinicalTrials.gov record NCT04697004. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04697004
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 200 participants
Conditions and interventions
Conditions
Interventions
Device
Eligibility (public fields only)
- Age range
- 22 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 31, 2021
- Primary completion
- Mar 29, 2026
- Completion
- Mar 29, 2026
- Last update posted
- Oct 1, 2024
2021 – 2026
United States locations
- U.S. sites
- 11
- U.S. states
- 8
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cedars-Sinai Kerlan-Jobe Institute | Los Angeles | California | 90045 | Withdrawn |
| Western Orthopaedics | Denver | Colorado | 80218 | Active, not recruiting |
| Levy Shoulder Center | Boca Raton | Florida | 33428 | Recruiting |
| AdventHealth | Orlando | Florida | 32803 | Recruiting |
| Rush Orthopaedics | Chicago | Illinois | 60612 | Recruiting |
| Upstate Orthopedics | East Syracuse | New York | 13057 | Recruiting |
| Duke University | Durham | North Carolina | 27708 | Active, not recruiting |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | Withdrawn |
| Rothman Orthopaedic | Philadelphia | Pennsylvania | 19107 | Recruiting |
| Guthrie | Sayre | Pennsylvania | 18840 | Recruiting |
| University of Texas- Health Science Center | San Antonio | Texas | 78229 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04697004, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 1, 2024 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04697004 live on ClinicalTrials.gov.