Connective Tissue Matrix for Rotator Cuff Tendinopathy

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06160427
Study type	Interventional
Source	Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Contact	Patrick Demeo, MD
Phone	412-359-3895
Email	patrick.demeo@ahn.org
Status	Recruiting
Phase	Phase 4
Start date	December 4, 2023
Completion date	January 15, 2028

View Details

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