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

Osteoarthritis Clinical Trial

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

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.

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 Small unpublished case series in total knee arthroplasty, ENT procedures, and rotator cuff repair have shown beneficial results from CTM.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

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06171529
Study type Interventional
Source Indiana Hand to Shoulder Center
Contact
Status Enrolling by invitation
Phase N/A
Start date March 7, 2023
Completion date January 31, 2026
View Details
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