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Efficacy of a Single Image Guided Injection of CTM for Glenohumeral Arthritis — HC22-1  

Shoulder Osteoarthritis Clinical Trial

Official title:
Efficacy of a Single Image Guided Injection of Connective Tissue Matrix for Glenohumeral Arthritis

Clinical Trial Summary

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. The goal of this study is to determine the success rate of a single, image guided glenohumeral CTM injection (for radiographically confirmed glenohumeral osteoarthritis at follow up intervals of 1, 2, 3, 4, 6, 9, and 12 months. This will be measured using the Likert Pain Scale (LPS) and Oxford Shoulder Score (OSS). Secondary goals are to identify if certain demographic or imaging factors exist that predict early symptom recurrence requiring additional intervention, defined as a second connective tissue matrix injection, a subsequent corticosteroid injection, or arthroplasty.

Clinical Trial Description

A recent prospective study by our center identified a clinically meaningful and statistical improvement after corticosteroid injection in the Oxford Shoulder Score and VAS pain scores in patients with glenohumeral arthritis2. 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. Osteoarthritis creates pain due to damaged tissues. CTM has been approved to supplement and replace damaged tissues. It is not replacing the damaged cartilage with new cartilage, but rather with other connective tissues. Previous unpublished studies in tonsil surgery and knee arthritis surgery have shown improvement from the CTM injections. Image guided injection of the glenohumeral joint has been shown to be more accurate than blind in-office injections and will thus be used in this study3. The goal of this study is to determine the success rate of a single, image guided glenohumeral (GH) CTM injection (for radiographically confirmed glenohumeral osteoarthritis at follow up intervals of 1, 2, 3, 4, 6, 9, and 12 months. This will be measured using the Likert Pain Scale (LPS) and Oxford Shoulder Score (OSS). Secondary goals are to identify if certain demographic or imaging factors exist that predict early symptom recurrence requiring additional intervention, defined as a second connective tissue matrix injection, a subsequent corticosteroid injection, or arthroplasty. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06171542
Study type Interventional
Source Indiana Hand to Shoulder Center
Contact
Status Active, not recruiting
Phase Phase 1
Start date December 22, 2022
Completion date April 30, 2025
View Details
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