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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 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. The trial reports 11 study locations across 8 states.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04697004
The ClinicalTrials.gov registry entry for NCT04697004 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Limacorporate S.p.a, which has 2 total studies on file at ClinicalTrials.gov.
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 reports 11 study locations spanning 8 distinct geographic areas - top geographies include 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.
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