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

NCT ID: NCT06171529

Last Updated: 2024-03-28

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-07
• Study Completion Date: 2026-01-31

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.

Detailed Description

CTM Biomedical markets and distributes decellularized particulate human placental connective-tissue matrix products, intended solely for homologous use to supplement or replace damaged or inadequate connective-tissue. These are structural tissue allografts processed according to the criteria contained in 21CFR 1271.10(a) for regulation solely under section 361 of the Public Health Service Act. CTM Flow is decellularized particulate human placental connective-tissue matrix provided in a vial.

Postoperative pain after basilar thumb arthritis reconstruction is often quite significant. CTM flow is an extracellular matrix implant that supplements and replaces damaged tissues. Small unpublished case series in total knee arthroplasty, ENT procedures, and rotator cuff repair have shown beneficial results from CTM. We hope to show similar results in this assessment of CTM in the Post-operative CMC arthroplasty patient population.

The primary outcome measure will be narcotic use postoperatively in the first 3 weeks after surgery, as measured by patient tracking. Patients will track post-op pain meds including narcotics, and OTC pain medication for the duration of their follow up period. Per standard of care, patients will be encouraged to change to Tylenol and/or ibuprofen pain medicine as soon as they are able.

Secondary outcomes will be quickDASH and VAS pain.

Conditions

Osteoarthritis; Osteoarthritis Thumb Base Joint; Carpometacarpal Osteoarthritis; Thumb

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo - Saline

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

placebo/Saline control injection

Treatment - CTM

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 Type: EXPERIMENTAL

CTM

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Placebo

placebo/Saline control injection

Intervention Type: OTHER

Other Intervention Names

Saline

Eligibility Criteria

Inclusion Criteria

1. Males or females age 18 or older

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

3. Patients who can consent to be a part of this study

4. Patients who are able to return to the Indiana Hand to Shoulder Center or satellite location for follow up time points

Exclusion Criteria

1. Additional procedures at the same time

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

3. Chronic narcotic use

4. Women who are pregnancy or breastfeeding

5. Non-English speaking

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CTM Biomedical

INDUSTRY

Sponsor Role: collaborator

Indiana Hand to Shoulder Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Indiana Hand to Shoulder Center

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

IHTSC CTM Series HC22-3

Identifier Type: -

Identifier Source: org_study_id