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SMR Stemless Reverse Vs SMR Reverse Shoulder System

NCT04697004 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-10-02

No results posted yet for this 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

  • Arthroplasty, Replacement

Interventions

DEVICE

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.

DEVICE

Control Arm: SMR Reverse Shoulder System

Conventional stemmed shoulder prostheses are commonly used in the clinical practice.

Sponsors & Collaborators

  • NAMSA

    collaborator OTHER

  • Limacorporate S.p.a

    lead INDUSTRY

Principal Investigators

  • Grant Garrigues, M.D. · Rush Orthopedics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2026-03-30
Completion
2026-03-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04697004 on ClinicalTrials.gov