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ACTIVE NOT RECRUITING
NCT06160427
PHASE4

Connective Tissue Matrix for Rotator Cuff Tendinopathy

Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

View on ClinicalTrials.gov

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.

Official title: Connective Tissue Matrix (CTM) for Rotator Cuff Tendinopathy: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

92

Start Date

2023-12-04

Completion Date

2028-01-15

Last Updated

2025-09-08

Healthy Volunteers

No

Interventions

BIOLOGICAL

CTM Boost

Connective Tissue Matrix (CTM) Boost is a decellularized Human Cellular and Tissue Based Allograft derived from placental connective tissue. It is considered a minimally-manipulated biologic by the FDA and is marketed as an allograft for repairing connective tissue. It is administered via injection.

BIOLOGICAL

PRP

PRP is derived by a sample of blood drawn from a patient and concentrated to include mainly platelets and potent inflammatory mediators which promote healing. At baseline, a blood draw of 60 milliliter (mL) will be obtained and concentrated in an Angel System to yield 5 cc of PRP and a supra-physiological concentration of white blood cells. All injections will be done under ultrasound guidance. A two-part injection process will be used. An advancing 20 gauge 1.5-inch needle first placed 3 mL of 1% xylocaine proximal to the tendinopathic area or tear. The needle will then be re-inserted at the proximal aspect of the lesion and slowly removed while infiltrating of 5 mL of PRP without activation with Calcium Chloride/thrombin at the lesion and surrounding tendon.

Locations (4)

Allegheny Health Network Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Allegheny Health Network Federal North Medical Office Building

Pittsburgh, Pennsylvania, United States

AHN Wexford Health & Wellness Pavilion

Wexford, Pennsylvania, United States

AHN Wexford Hospital

Wexford, Pennsylvania, United States