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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04697004
Study type Interventional
Source Limacorporate S.p.a
Contact Fabiana Pavan
Phone +39 348 5816391
Email Fabiana.Pavan@limacorporate.com
Status Recruiting
Phase N/A
Start date April 1, 2021
Completion date March 30, 2026

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