Ignite Creation Date:
2024-05-06 @ 3:06 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04529798
Status:
RECRUITING
Last Update Posted:
2022-07-25
First Post:
2020-08-25
Brief Title:
Clinical Study Evaluating Outcomes of Reverse Shoulder Arthroplasty With SMR Stemless
Sponsor:
Arthro Medics AG
Organization:
Arthro Medics AG
Study Overview
Official Title:
A Monocentric Clinical Study Evaluating Clinical and Patient-reported Outcomes of Reverse Shoulder Arthroplasty With SMR Stemless
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
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:
SSPR
Brief Summary:
The objectives of this study are the assessment of the clinical radiographical and patient-reported outcomes of SMR Stemless Reverse Shoulder Arthroplasty LimaCorporate SpA used as standard of care over a period of at least 2 years of follow-up and the evaluation of the incidence of any complication
Detailed Description:
The focus of this study is the evaluation on clinical patient-reported and radiographical outcomes of SMR Stemless Reverse Shoulder Arthroplasty There is a retrospective and prospective study population
The follow up time-points are as of standard of care and not different for this study
Baseline
6 weeks postop
6 months postop
12 months postop
24 months postop
The follow up time-points are as of standard of care and not different for this study
Baseline
6 weeks postop
6 months postop
12 months postop
24 months postop
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