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CTM Injection for Thumb Arthritis (CTM CMC Trial)

N/A

Waitlist Available

Research Sponsored by Indiana Hand to Shoulder Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients presenting for basilar thumb reconstruction surgery (any surgical technique)

Be older than 18 years old

Must not have

Patients with previous basilar thumb reconstruction on the operative side (revision surgery)

Women who are pregnancy or breastfeeding

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Summary

This trial will measure the effectiveness of an injection to treat thumb arthritis after surgery. #arthritis #thumb #injection

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Potential side effects of the CTM injection are not detailed here, but common injection-related side effects might include pain at the injection site, swelling, bruising, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am having surgery for my thumb base.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am not pregnant or breastfeeding.

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I do not speak English.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Narcotic Use

Secondary study objectives

VAS Pain

quickDASH

Trial Design

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.

0 / 4Eligibility criteria met