Connective Tissue Matrix Compared to Steroid Injections for Rotator Cuff Tendinopathy

NARecruitingINTERVENTIONAL
Enrollment

52

Participants

Timeline

Start Date

November 25, 2024

Primary Completion Date

October 31, 2025

Study Completion Date

December 31, 2025

Conditions
Rotator Cuff Tendinopathy
Interventions
DRUG

celgene

"CTM Boost (CTM Biomedical, Miami, FL) is a decellularized Human Cellular and Tissue Based Allograft (HCT/P) derived from placental connective tissue. It is marketed as an allograft for homologous use to supplement or replace damaged or inadequate connective tissue. It is regulated as a minimally-manipulated biologic by the FDA and is marketed as an allograft for homologous use to supplement or replace damaged or inadequate connective tissue. It is administered applied into the tissue via injection.~Participant will undergo a single injection of 2.0cc of the injectable CTM allograft, administered using a 20G needle in the subacromial space. 3mL of ropivacaine will be mixed into the syringe prior to administration of the injection. Posttreatment pain control (hydrocodone/acetaminophen #20 5/500 mg) will be used."

DRUG

Corticosteroid

Kenalog-40 is a long-acting corticosteroid injection for intramuscular (into the muscle) or intra-articular (into the joints) use. It may be used to treat many different types of inflammatory conditions. In this study, a 2.0cc dose injection of Kenalog-40 will be administered directly into the subacromial space using a 20G needle. 3mL of ropivacaine will be injected along with the steroid (as part of the same injection). Posttreatment pain control (hydrocodone/acetaminophen #20 5/500 mg) will be used.

Trial Locations (1)

15212

RECRUITING

Allegheny Health Network Federal North Medical Office Building, Pittsburgh

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

CTM Biomedical

INDUSTRY

lead

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

OTHER