Status:
UNKNOWN
Efficacy of a Single Image Guided Injection of CTM for Glenohumeral Arthritis
Lead Sponsor:
Indiana Hand to Shoulder Center
Collaborating Sponsors:
CTM Biomedical
Conditions:
Osteoarthritis Shoulder
Glenohumeral Osteoarthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 c...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06171542
Start Date
December 22 2022
End Date
April 30 2025
Last Update
March 27 2024
Active Locations (1)
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1
Indiana Hand to Shoulder Center
Indianapolis, Indiana, United States, 46260