Ignite Creation Date:
2024-05-06 @ 7:28 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06025448
Status:
RECRUITING
Last Update Posted:
2023-11-07
First Post:
2023-06-28
Brief Title:
Is MIO-RSA Noninferior to BIO-RSA When it Comes to Mechanical Implant Stability
Sponsor:
Lovisenberg Diakonale Hospital
Organization:
Lovisenberg Diakonale Hospital
Study Overview
Official Title:
From Cuff Arthropathy to Reverse Shoulder Arthroplasty - a Multicentre Randomized Control Trial CARS 2 Is MIO-RSA Noninferior to BIO-RSA When it Comes to Mechanical Implant Stability Measured With CT-based Motion Analysis CTMA
Status:
RECRUITING
Status Verified Date:
2023-11
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:
CARS-2
Brief Summary:
This clinical trial will investigate whether metallic lateralization in reverse shoulder arthroplasty is as stable as bony lateralization during the first two postsurgical years measured with CT-based motion analysis CTMA
Detailed Description:
Lateralization of reverse shoulder arthroplasties may reduce the risk for complications such as limited range of motion ROM and scapular notching where the lower part of the scapular neck becomes eroded due to impingement against the humeral component Theres several ways to lateralize the glenoid component a bone transplant placed underneath the glenoid component Bony Increased Offset Reversed Shoulder Arthroplasty BIO-RSA has been used for some time Recently glenoid components with metallic lateralization of the joint centre Metal-Increased Offset Reversed Shoulder Arthroplasty MIO-RSA have been introduced but there is not much comparative literature on metal vs bony lateralization
Patients with osteoarthritis and medialization of the glenoid articular surface who willing to participate in a study will be randomized to receive either MIO-RSA or a BIO-RSA CT-based motion analysis CTMA will be used to measure the 3-dimensional migration pattern of the glenoid components to assess the stability of the prostheses up to two years after implantation
Patients with osteoarthritis and medialization of the glenoid articular surface who willing to participate in a study will be randomized to receive either MIO-RSA or a BIO-RSA CT-based motion analysis CTMA will be used to measure the 3-dimensional migration pattern of the glenoid components to assess the stability of the prostheses up to two years after implantation
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