CTM Injection for Shoulder Osteoarthritis

(HC22-1 Trial)

Overseen By Lexie Reissaus

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Indiana Hand to Shoulder Center

Disqualifiers: Inflammatory arthritis, Brachial plexopathy, Cervical spine abnormalities, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for individuals with shoulder osteoarthritis confirmed by X-rays. Participants will receive a single CTM injection guided by imaging to help with their condition. The study aims to track pain relief and improved shoulder function over time.

Inclusion Criteria

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

Patients who can consent to be a part of this study

I am getting a CTM injection as my first treatment.

Exclusion Criteria

Those unable to keep up monthly communication through phone calls and/or electronic PROs

I have nerve damage in my shoulder.

I have inflammatory arthritis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single image-guided injection of CTM for glenohumeral arthritis

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment at intervals of 1, 2, 3, 4, 6, 9, and 12 months

12 months

Multiple visits (in-person)

Treatment Details

Interventions

• CTM Injection

Trial Overview The trial tests the effectiveness of a human placental connective-tissue matrix (CTM) injection in managing shoulder osteoarthritis. Success rates are measured using pain and shoulder function scores at multiple intervals up to one year post-injection.

Participant Groups

Group I: CTM Shoulder Injection Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Indiana Hand to Shoulder Center

Lead Sponsor

Trials

9

Recruited

320+

CTM Biomedical

Industry Sponsor

Trials

5

Recruited

200+