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Treatment - CTM for Osteoarthritis (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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

CTM CMC Trial 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.Check my eligibility

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.See study design

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.

CTM CMC Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I am having surgery for my thumb base.

CTM CMC Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Narcotic Use

Secondary outcome measures

VAS Pain

quickDASH

CTM CMC 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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Indiana Hand to Shoulder CenterLead Sponsor

8 Previous Clinical Trials

300 Total Patients Enrolled

2 Trials studying Osteoarthritis

80 Patients Enrolled for Osteoarthritis

CTM BiomedicalIndustry Sponsor

3 Previous Clinical Trials

99 Total Patients Enrolled

1 Trials studying Osteoarthritis

30 Patients Enrolled for Osteoarthritis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent are individuals engaging in this experiment?

"Affirmative. According to the information present on clinicaltrials.gov, this medical trial is currently seeking participants; it was initially posted on March 7th 2023 and most recently updated December 6th 2023. The team aims to enrol 50 individuals at a single site."

Answered by AI

Is enrolment for this trial still accessible to volunteers?

"Affirmative. Clinicaltrials.gov reveals that this scientific research, which was originally published on March 7th 2023, is presently looking for participants. To reach its recruitment goals, the clinical trial requires 50 patients from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Efficacy of a Single Injection of CTM for Post-Operative CMC Arthritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06171529.

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