Connective Tissue Matrix (CTM) Compared to Corticosteroid Injections: A Pilot Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of the study is to see which is better at treating patients which rotator cuff tendinopathy (RCT): a single injection of Connective Tissue Matrix boost (CTM) or a steroid shot. Patients will be randomized (like flipping a coin) to the treatment. Patients and researchers will be blinded (not know) what group the patients are in. Patients will come back to the study clinic at 6 weeks, 3 months and 6 months after the shot to answer questionnaires, have a physical exam, and complete physical function tests to check their shoulder.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Patients aged 18-80 years old with rotator cuff tendinopathy

• A corticosteroid or CTM-type injection was determined by the clinician to be the proper medical treatment course and patient is willing to undergo the injection

Locations
United States
Pennsylvania
Allegheny Health Network Federal North Medical Office Building
RECRUITING
Pittsburgh
Contact Information
Primary
Clinical Trials
Clinicaltrials@ahn.org
1-877-660-6777
Time Frame
Start Date: 2024-11-25
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 52
Treatments
Placebo_comparator: 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.
Experimental: CTM Boost
TM 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.
Related Therapeutic Areas
Sponsors
Leads: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Collaborators: CTM Biomedical

This content was sourced from clinicaltrials.gov