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NCT04697004 · ClinicalTrials.gov registry record · NA
SMR Stemless Reverse Vs SMR Reverse Shoulder System
A NA study of Arthroplasty, Replacement, sponsored by Limacorporate S.p.a.
- Recruiting
- Registry status
- NA
- Development phase
- 200
- Enrollment target
- 11
- Study locations
NCT04697004: Recruiting NA study of Arthroplasty, Replacement, sponsored by Limacorporate S.p.a.
NCT04697004 is a NA study of Arthroplasty, Replacement that is actively recruiting participants, run by Limacorporate S.p.a. The registered enrollment target is 200 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower). The trial reports 11 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04697004, a NA study of Arthroplasty, Replacement, is actively recruiting participants, sponsored by Limacorporate S.p.a.
- RECRUITING
- Registry status
- NA
- Development phase
- 200 participants
- Enrollment target
- 11
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DEVICE Investigational Arm: SMR Stemless Reverse
- DEVICE Control Arm: SMR Reverse Shoulder System
Study Locations (11)
Pennsylvania
- University of Pennsylvania - Philadelphia
- Rothman Orthopaedic - Philadelphia
- Guthrie - Sayre
Florida
- Levy Shoulder Center - Boca Raton
- AdventHealth - Orlando
California
- Cedars-Sinai Kerlan-Jobe Institute - Los Angeles
Colorado
- Western Orthopaedics - Denver
Illinois
- Rush Orthopaedics - Chicago
New York
- Upstate Orthopedics - East Syracuse
North Carolina
- Duke University - Durham
Texas
- University of Texas- Health Science Center - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2021-04-01 |
| Est. Completion | 2026-03-30 |
| Phase | NA |
What NCT04697004 shows while recruiting
NCT04697004 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Arthroplasty, Replacement appearing as the primary indexed condition, and to 2 interventions - of which Investigational Arm: SMR Stemless Reverse is the first listed.
NCT04697004 lists 11 locations in 8 states (Pennsylvania, Florida, California).
Frequently Asked Questions
What is clinical trial NCT04697004 about?
NCT04697004 is a clinical study titled "SMR Stemless Reverse Vs SMR Reverse Shoulder System". 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 Shou...
What is the current status of trial NCT04697004?
This trial is currently recruiting. It is a NA study. The enrollment target is 200 participants. The study started on 2021-04-01. Estimated completion is 2026-03-30.
What conditions does trial NCT04697004 study?
This clinical trial studies the following conditions: Arthroplasty, Replacement.
What interventions are being tested in trial NCT04697004?
The interventions under investigation include: Investigational Arm: SMR Stemless Reverse (DEVICE), Control Arm: SMR Reverse Shoulder System (DEVICE).
Who is sponsoring clinical trial NCT04697004?
This trial is sponsored by Limacorporate S.p.a, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04697004 being conducted?
This trial has 11 study locations across California, Colorado, Florida, Illinois, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04697004's enrollment target sits among peer trials
200 506th of 2000 higher than 1,435 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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