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

NCT06171542 | Unknown Phase 1 FDA Device

• 1 other identifier: IHTSC CTM Project HC22-2
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis Shoulder; Glenohumeral Osteoarthritis; Shoulder Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• Likert Pain Scale

  PROM

  12 Months

• Oxford Shoulder Score

  PROM

  12 Months

Study Arms (1)

CTM Shoulder Injection

EXPERIMENTAL

Device: CTM Injection

Interventions

CTM Injection 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.

CTM Shoulder Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Radiographic documented Glenohumeral osteoarthritis (grade 1-3)
• Males or females age 18 or older
• Patients receiving a CTM injection for their initial treatment
• Patients who can consent to be a part of this study
• Patients who are able keep up regular communication through phone calls or electronic PROs

You may not qualify if:

• Inflammatory Arthritis
• Brachial Plexopathy
• Cervical spine abnormalities such as radiculopathies
• age less than 18 years
• those unable to keep up monthly communication through phone calls and/or electronic PROs
• Absence of glenohumeral osteoarthritis
• Pregnancy or breastfeeding
• Non-english speaking

Sponsors & Collaborators

• Indiana Hand to Shoulder Center: lead
• CTM Biomedical: collaborator

Study Sites (1)

Indiana Hand to Shoulder Center

Indianapolis, Indiana, 46260, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: December 14, 2023
• Study Start: December 22, 2022
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2025
• Last Updated: March 27, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)