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

NCT06171529 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-03-28

No results posted yet for this study

Summary

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.

Conditions

  • Osteoarthritis
  • Osteoarthritis Thumb Base Joint
  • Carpometacarpal Osteoarthritis
  • Thumb

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

Sponsors & Collaborators

  • CTM Biomedical

    collaborator INDUSTRY

  • Indiana Hand to Shoulder Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-07
Primary Completion
2025-12-31
Completion
2026-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06171529 on ClinicalTrials.gov