Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING NA

SMR Stemless Reverse Vs SMR Reverse Shoulder System

NCT04697004 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 200 participants
Start Date 2021-04-01
Est. Completion 2026-03-30
Phase NA

Sponsor

Limacorporate S.p.a

29 total trials

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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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 29 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04697004 reports 11 study locations spanning 8 distinct geographic areas — top geographies include Pennsylvania, Florida, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04697004?

This trial is sponsored by Limacorporate S.p.a, which has 29 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial