Ignite Creation Date:
2024-05-06 @ 2:27 AM
Last Modification Date:
2024-10-26 @ 11:18 AM
Study NCT ID:
NCT02049684
Status:
COMPLETED
Last Update Posted:
2019-08-19
First Post:
2014-01-23
Brief Title:
SPARC Shoulder PAtch for Rotator Cuff Tears
Sponsor:
The Leeds Teaching Hospitals NHS Trust
Organization:
The Leeds Teaching Hospitals NHS Trust
Study Overview
Official Title:
SPARC Shoulder PAtch for Rotator Cuff Tears
Status:
COMPLETED
Status Verified Date:
2019-08
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:
Rotator cuff tears injury to the muscle or tendons which stabilise the shoulder are one of the most common conditions affecting the shoulder Small and medium sized rotator cuff tears can be managed with arthroscopic or keyhole surgery Very large or massive tears are difficult to operate on and often have poor rates of healing As a result surgeons have investigated the use of products to improve the outcome of surgery on massive tears
The product that the investigators are currently using to try to improve the outcome of surgery for massive rotator cuff tears is called a patch The patch provides a scaffold to support the muscles of the rotator cuff Studies of rotator cuff surgery using similar patches have found that recovery is improved and there is a lower rate of postsurgical problems The aim of this study is to look at whether using the patch improves pain and the clinical function of the shoulder after surgery In addition the investigators would like to understand how the patch works To do this the investigators will scan take images of the shoulder using magnetic resonance imaging to look at the muscle damage in the shoulder before and after surgery
The product that the investigators are currently using to try to improve the outcome of surgery for massive rotator cuff tears is called a patch The patch provides a scaffold to support the muscles of the rotator cuff Studies of rotator cuff surgery using similar patches have found that recovery is improved and there is a lower rate of postsurgical problems The aim of this study is to look at whether using the patch improves pain and the clinical function of the shoulder after surgery In addition the investigators would like to understand how the patch works To do this the investigators will scan take images of the shoulder using magnetic resonance imaging to look at the muscle damage in the shoulder before and after surgery
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 13YH0030 | OTHER | Research Ethics Committee | None |