Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06289686
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-02-22
Brief Title:
MIRROR Project 44 - Rotator Cuff Repairs With or Without BioEnthesis Augmentation
Sponsor:
Brooke Army Medical Center
Organization:
Brooke Army Medical Center
Study Overview
Official Title:
MIRROR Project 44 - Rotator Cuff Repairs With or Without BioEnthesis Augmentation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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 RC injuries are particularly prevalent difficult to repair and attachment between the bone and tendon is notoriously difficult to achieve The most common method and current standard of care SOC for reattaching connective tissues eg ligaments tendons to bone typically involves suture anchor-based techniques but this is fraught with problems More specifically re-tearing of the connective tissue after this procedure occurs in 30-60 of cases and can be even higher in patients who engage in smoking have a diagnosis of diabetes etc To address these clinical challenges Sparta Biopharma Inc Sparta developed a unique technology called BioEnthesis to improve the connection between the tendon and bone Pre-clinical in vivo studies demonstrated that the biphasic bovine cancellous matrix regenerated at the bone-soft tissue interface-thereby leading to high structural integrity and will likely lead to reduced re-tear rates over time The investigators hypothesize that patients in this interventional cohort will experience enhanced mobility reduced pain and less re-tears after RC procedures versus a standard suture anchor-based repair
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?:
True
Is an FDA AA801 Violation?:
None