NCT05339815

S-33 SMR Shoulder HP Reverse Glenosphere

Clinical and Radiographic Outcomes of Reverse Shoulder Arthroplasty Performed With 36-mm CoCrMo vs 40-mm Cross-linked UHMWPE Glenospheres.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 140 (estimated)
• Sponsor: Limacorporate S.p.a · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Study Design: Single arm, retrospective and prospective, single center, post-market clinical study Purpose:To demonstrate the safety and effectiveness of the SMR Reverse HP Shoulder System device for primary, fracture or revision total shoulder replacement out to 24 months. The eligible study population is the entire population that underwent a reverse shoulder arthroplasty performed with 36-mm CoCrMo versus 40-mm cross-linked UHMWPE glenospheres between January 1, 2013 and January 1, 2020 at Wrightington Hospital (UK) in accordance with the indication for use of the product.

Conditions

• Arthroplasty, Replacement, Shoulder

Interventions

Type	Name	Description
DEVICE	SMR shoulder arthroplasty	Data collection of population that underwent a reverse shoulder arthroplasty performed with SMR 36-mm CoCrMo versus 40-mm cross-linked UHMWPE glenospheres

Timeline

• Start date: 2022-10-17
• Primary completion: 2023-02-01
• Completion: 2023-05-01
• First posted: 2022-04-21
• Last updated: 2022-10-24

Locations

1 site across 1 country: United Kingdom