NCT04697004

SMR Stemless Reverse Vs SMR Reverse Shoulder System

A Randomized, Multi-Center, Prospective, Safety and Efficacy Study Comparing the Outcome of Total Reverse Shoulder Arthroplasty (RSA) with SMR Stemless Reverse Vs SMR Reverse Shoulder System

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Limacorporate S.p.a · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2021-04-01
• Primary completion: 2026-03-30
• Completion: 2026-03-30
• First posted: 2021-01-06
• Last updated: 2024-10-02

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated device study