Efficacy of a Single Injection of CTM for Post-Operative CMC Arthritis

NAEnrolling by invitationINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

March 7, 2023

Primary Completion Date

December 31, 2025

Study Completion Date

January 31, 2026

Conditions
OsteoarthritisOsteoarthritis Thumb Base JointCarpometacarpal OsteoarthritisThumb
Interventions
DEVICE

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.

OTHER

Placebo

placebo/Saline control injection

Trial Locations (1)

46260

Indiana Hand to Shoulder Center, Indianapolis

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

CTM Biomedical

INDUSTRY

lead

Indiana Hand to Shoulder Center

OTHER