Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT06171542 |
Other study ID # |
IHTSC CTM Project HC22-2 |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
Phase 1
|
First received |
|
Last updated |
|
Start date |
December 22, 2022 |
Est. completion date |
April 30, 2025 |
Study information
Verified date |
December 2023 |
Source |
Indiana Hand to Shoulder Center |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
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.
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 Previous unpublished studies in tonsil surgery and knee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.