CTM Injection for Thumb Arthritis
(CTM CMC Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Indiana Hand to Shoulder Center

Trial Summary

What is the purpose of this trial?

The goal of this study is to determine the success rate of a single Carpometacarpal (CMC) thumb injection after arthroplasty surgery for primary osteoarthritis of the CMC joint.

Research Team

Eligibility Criteria

This trial is for individuals who have had arthroplasty surgery to treat primary osteoarthritis in the thumb's carpometacarpal (CMC) joint. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be required to follow specific protocols.

Inclusion Criteria

I am having surgery for my thumb base.

I can go back to the Indiana Hand to Shoulder Center for follow-ups.

Patients who can consent to be a part of this study

See 1 more

Exclusion Criteria

I have had surgery before on the base of my thumb on the side that needs operation now.

Chronic narcotic use

I am not pregnant or breastfeeding.

See 2 more

Treatment Details

Interventions

CTM (Procedure)

Trial OverviewThe study is testing the effectiveness of a single injection treatment called CTM after CMC thumb joint surgery. Participants will either receive the CTM injection or a placebo to compare outcomes.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Treatment - CTMExperimental Treatment1 Intervention

For patients who randomize to CTM: An unblinded IHTSC Fellow, nurse/PA, or OR staff will use a 3 or 5 cc syringe to draw up the CTM Flow material. A 23, or 20 gauge needle will be used to inject the CTM after arthroplasty and prior to closure of the capsule. To draw up the injection: allow the particulate to settle to the bottom and withdrawal fluid into the 3 or 5 cc syringe. It is ok if some particulate is drawn up into the syringe. 2cc of CTM will be injected into each patient.

Group II: Placebo - SalinePlacebo Group1 Intervention

For patients who randomize to Saline: An unblinded IHTSC Fellow, nurse/PA, or OR staff will use a 3 or 5 cc syringe to draw up the saline. A 23 gauge needle will be used to inject the saline after arthroplasty and prior to closure of the capsule. 2cc of saline will be injected into each patient.