Efficacy of a Single Image Guided Injection of CTM for Glenohumeral Arthritis

NCT ID: NCT06171542

Last Updated: 2024-03-27

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-22
• Study Completion Date: 2025-04-30

Brief 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.

Detailed 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 Previous unpublished studies in tonsil surgery and knee arthritis surgery have shown improvement from the CTM injections.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.

Conditions

Osteoarthritis Shoulder; Glenohumeral Osteoarthritis; Shoulder Osteoarthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CTM Shoulder Injection

Group Type: EXPERIMENTAL

CTM Injection

Intervention Type: DEVICE

All glenohumeral joint injections will be performed by a physician under the guidance of either ultrasound or fluoroscopy to ensure and document intra-articular needle placement. 2cc of CTM Flow will be injected. The glenohumeral joint will be injected with the medication under the discretion of the treating surgeon.

Interventions

CTM Injection

All glenohumeral joint injections will be performed by a physician under the guidance of either ultrasound or fluoroscopy to ensure and document intra-articular needle placement. 2cc of CTM Flow will be injected. The glenohumeral joint will be injected with the medication under the discretion of the treating surgeon.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Radiographic documented Glenohumeral osteoarthritis (grade 1-3)

2. Males or females age 18 or older

3. Patients receiving a CTM injection for their initial treatment

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

5. Patients who are able keep up regular communication through phone calls or electronic PROs

Exclusion Criteria

1. Inflammatory Arthritis

2. Brachial Plexopathy

3. Cervical spine abnormalities such as radiculopathies

4. age less than 18 years

5. those unable to keep up monthly communication through phone calls and/or electronic PROs

6. Absence of glenohumeral osteoarthritis

7. Pregnancy or breastfeeding

8. 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 Project HC22-2

Identifier Type: -

Identifier Source: org_study_id