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

Osteoarthritis Clinical Trial

— CTM CMC  

Official title:

Efficacy of a Single Injection of Connective Tissue Matrix for Post-Operative CMC Arthritis

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06171529
• Other study ID #: IHTSC CTM Series HC22-3
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 7, 2023
• Est. completion date: January 31, 2026

Study information

• Verified date: December 2023
• Source: Indiana Hand to Shoulder Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 Small unpublished case series in total knee arthroplasty, ENT procedures, and rotator cuff repair have shown beneficial results from CTM.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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: January 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carpometacarpal Osteoarthritis
• Osteoarthritis

Intervention

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

Locations

Country	Name	City	State
United States	Indiana Hand to Shoulder Center	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana Hand to Shoulder Center	CTM Biomedical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Narcotic Use	number of narcotic medications taken in recover	6 Weeks
Secondary	VAS Pain	PROM	6 Months
Secondary	quickDASH	PROM	6 Months