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

NCT06171529 | Unknown FDA Device

• 1 other identifier: IHTSC CTM Series HC22-3
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Narcotic Use

  number of narcotic medications taken in recover

  6 Weeks

Secondary Outcomes (2)

• VAS Pain

  6 Months

• quickDASH

  6 Months

Study Arms (2)

Placebo - Saline

PLACEBO COMPARATOR

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.

Other: Placebo

Treatment - CTM

EXPERIMENTAL

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.

Device: CTM

Interventions

CTM DEVICE

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.

Treatment - CTM

Placebo OTHER

placebo/Saline control injection

Also known as: Saline

Placebo - Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females age 18 or older
• Patients presenting for basilar thumb reconstruction surgery (any surgical technique)
• Patients who can consent to be a part of this study
• Patients who are able to return to the Indiana Hand to Shoulder Center or satellite location for follow up time points

You may not qualify if:

• Additional procedures at the same time
• Patients with previous basilar thumb reconstruction on the operative side (revision surgery)
• Chronic narcotic use
• Women who are pregnancy or breastfeeding
• Non-English speaking

Sponsors & Collaborators

• Indiana Hand to Shoulder Center: lead
• CTM Biomedical: collaborator

Study Sites (1)

Indiana Hand to Shoulder Center

Indianapolis, Indiana, 46260, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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. 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.

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: December 14, 2023
• Study Start: March 7, 2023
• Primary Completion: December 31, 2025
• Study Completion: January 31, 2026
• Last Updated: March 28, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)