Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06160427
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2023-11-29
Brief Title:
Connective Tissue Matrix for Rotator Cuff Tendinopathy
Sponsor:
Allegheny Singer Research Institute also known as Allegheny Health Network Research Institute
Organization:
Allegheny Singer Research Institute also known as Allegheny Health Network Research Institute
Study Overview
Official Title:
Connective Tissue Matrix CTM for Rotator Cuff Tendinopathy A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-03
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:
The purpose of this research study is to determine if the effectiveness of a single injection of CTM Boost in the treatment of patients with rotator cuff tendinopathy RCT is as effective as a single injection of platelet rich plasma PRP in reducing the symptoms of RCT
Detailed Description:
Rotator cuff tendinopathy RCT is a chronic degenerative process which causes both shoulder pain as well as limited range of motion It is currently estimated that approximately 5 of RCT is being managed surgically which highlights the importance of effective non-operative treatment strategies
The advent of platelet rich plasma PRP a sample of blood drawn from a patient and concentrated to include mainly platelets and potent inflammatory mediators which promote healing has shown promise as another treatment modality when injected at the site of tendon damage Placenta-derived decellularized connective tissue matrix CTM may represent an alternative therapy for RCT Placenta-derived biologics can be administered as an injection and have been shown to promote tenocyte proliferation and to reduce inflammation in vitro thus potentially accelerating and enhancing tendon healing
This study is being conducted to determine if injection of CTM Boost is non-inferior to injection of PRP with regard to pain and function at Month 6 post-injection in patients with rotator cuff tendinopathy
The advent of platelet rich plasma PRP a sample of blood drawn from a patient and concentrated to include mainly platelets and potent inflammatory mediators which promote healing has shown promise as another treatment modality when injected at the site of tendon damage Placenta-derived decellularized connective tissue matrix CTM may represent an alternative therapy for RCT Placenta-derived biologics can be administered as an injection and have been shown to promote tenocyte proliferation and to reduce inflammation in vitro thus potentially accelerating and enhancing tendon healing
This study is being conducted to determine if injection of CTM Boost is non-inferior to injection of PRP with regard to pain and function at Month 6 post-injection in patients with rotator cuff tendinopathy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None