Ignite Creation Date:
2024-05-06 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 2:30 PM
Study NCT ID:
NCT05339815
Status:
UNKNOWN
Last Update Posted:
2022-10-24
First Post:
2022-04-08
Brief Title:
S-33 SMR Shoulder HP Reverse Glenosphere
Sponsor:
Limacorporate Spa
Organization:
Limacorporate Spa
Study Overview
Official Title:
Clinical and Radiographic Outcomes of Reverse Shoulder Arthroplasty Performed With 36-mm CoCrMo vs 40-mm Cross-linked UHMWPE Glenospheres
Status:
UNKNOWN
Status Verified Date:
2022-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Study Design Single arm retrospective and prospective single center post-market clinical study PurposeTo 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None