Connective Tissue Matrix for Rotator Cuff Tendinopathy

PHASE4Active, not recruitingINTERVENTIONAL
Enrollment

92

Participants

Timeline

Start Date

December 4, 2023

Primary Completion Date

January 15, 2027

Study Completion Date

January 15, 2028

Conditions
TendinopathyShoulder PainRotator Cuff TendinitisRotator Cuff Tendinosis
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."

Trial Locations (4)

15090

AHN Wexford Health & Wellness Pavilion, Wexford

AHN Wexford Hospital, Wexford

15212

Allegheny Health Network Allegheny General Hospital, Pittsburgh

Allegheny Health Network Federal North Medical Office Building, Pittsburgh

All Listed Sponsors
collaborator

Connective Tissue Matrix Biomedical, LLC

UNKNOWN

lead

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

OTHER

NCT06160427 - Connective Tissue Matrix for Rotator Cuff Tendinopathy | Biotech Hunter | Biotech Hunter