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

Launched by INDIANA HAND TO SHOULDER CENTER · Dec 6, 2023

Keywords

ClinConnect Summary

This study is testing whether a single injection of CTM Flow, a tissue matrix made from human placenta tissue, given during basilar (thumb base) joint reconstruction surgery for thumb osteoarthritis, helps with recovery compared with a saline placebo. The main goal is to see if CTM reduces the use of narcotic pain medications in the first 3 weeks after surgery. Researchers will also look at hand function and pain at about 6 months after surgery.

About who can join: adults 18 and older who are having basilar thumb reconstruction for thumb base osteoarthritis at the Indiana Hand to Shoulder Center. Key inclusion: able to consent and return for follow-up visits. Exclusions include having another procedure at the same time, a previous basilar thumb reconstruction on the same thumb, chronic narcotic use, pregnancy or breastfeeding, or not speaking English. The trial plans to enroll about 50 participants, randomly assigned to either CTM or saline in a blinded setup (participants and most study staff don’t know which treatment you received). Each participant gets 2 cc injected after the arthroplasty procedure. The study is ongoing with completion expected around late 2025 to early 2026. CTM and saline injections are provided at no cost to participants, and the sponsor is CTM Biomedical partnering with Indiana Hand to Shoulder Center.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Males or females age 18 or older
• • 2. Patients presenting for basilar thumb reconstruction surgery (any surgical technique)
• • 3. Patients who can consent to be a part of this study
• • 4. Patients who are able to return to the Indiana Hand to Shoulder Center or satellite location for follow up time points
• Exclusion Criteria:
• • 1. Additional procedures at the same time
• • 2. Patients with previous basilar thumb reconstruction on the operative side (revision surgery)
• • 3. Chronic narcotic use
• • 4. Women who are pregnancy or breastfeeding
• • 5. Non-English speaking