Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06323980
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-02-27
Brief Title:
INHANCE Stemless Reverse Shoulder IDE
Sponsor:
DePuy Orthopaedics
Organization:
DePuy Orthopaedics
Study Overview
Official Title:
Randomized Prospective Multi-Center Study of the INHANCE Stemless Total Reverse Shoulder System
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
None
Brief Summary:
21 Randomized Controlled Multi-Center Prospective Pre-Market Study of the INHANCE Stemless Reverse Cementless Total Shoulder
Detailed Description:
There is one primary effectiveness endpoint and there are three primary safety endpoints
1 Primary effectiveness endpoint - Adjusted Constant-Murley Change from Baseline ACM CFB at 2 years post-operative
2 Primary safety endpoints
1 No revision removal reoperation supplemental fixation or other intervention for any system component
2 No humeral or glenoid radiolucent line 2 mm is present in 50 or more zones at 2 years
3 No conclusive evidence of migration and tilt 5mm migration and 10 tilt of the humeral or glenoid component at 2 years
The study will be successful if the primary effectiveness endpoint non-inferiority analysis is successfully demonstrated and no significant difference is seen on any of the 3 primary safety endpoints
1 Primary effectiveness endpoint - Adjusted Constant-Murley Change from Baseline ACM CFB at 2 years post-operative
2 Primary safety endpoints
1 No revision removal reoperation supplemental fixation or other intervention for any system component
2 No humeral or glenoid radiolucent line 2 mm is present in 50 or more zones at 2 years
3 No conclusive evidence of migration and tilt 5mm migration and 10 tilt of the humeral or glenoid component at 2 years
The study will be successful if the primary effectiveness endpoint non-inferiority analysis is successfully demonstrated and no significant difference is seen on any of the 3 primary safety endpoints
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None