50
Participants
Start Date
March 7, 2023
Primary Completion Date
December 31, 2025
Study Completion Date
January 31, 2026
CTM
CTM Flow is stored in 1cc vials and is stable at room temperature and does not need to be refrigerated. CTM Flow will be supplied to and stored at the IHTSC Beltway Surgery Center. Product will be stored at room temperature without continued temperature control. All product will be kept in the Beltway Surgery Center and will not be separated from the marketed non-study CTM. Treating Surgeons will remain blinded to the treatment group, but will ensure that only the injection is billed to patients and the CTM or saline are provided at no cost. Lexie Reissaus, CCRP will track drug accountability.
Placebo
placebo/Saline control injection
Indiana Hand to Shoulder Center, Indianapolis
Collaborators (1)
CTM Biomedical
INDUSTRY
Indiana Hand to Shoulder Center
OTHER