Ignite Creation Date:
2024-07-17 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06481046
Status:
WITHDRAWN
Last Update Posted:
2024-07-01
First Post:
2020-10-22
Brief Title:
Treatment of Rotator Cuff Tears With Platelet Rich Plasma
Sponsor:
The Foundation for Orthopaedics and Regenerative Medicine
Organization:
The Foundation for Orthopaedics and Regenerative Medicine
Study Overview
Official Title:
Treatment of Rotator Cuff Tears With Platelet Rich Plasma
Status:
WITHDRAWN
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Use of PRP does not require a registered clinical trial
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the safety and effectiveness of dual platelet rich plasma PRP injections into the rotator cuff insertion and the area of the tendon proximal to the insertion
Detailed Description:
Patients who have rotator cuff pathology as established by clinical exam and confirmed with MRI and have failed activity modification will be enrolled in this study They will receive dual platelet rich plasma PRP injections one into the rotator cuff insertion and one into the area of the tendon proximal to the insertion in one treatment session PRP will be prepared through a double spin technique to create two 4 cc doses for injection Patients will evaluated at 6 months 1 year and two years for improvement in symptoms
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