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Connective Tissue Matrix for Rotator Cuff Tendinopathy
Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
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
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.
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