Status:
WITHDRAWN
Amnion-Based Injections in the Shoulder
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
Osteoarthritis of the Shoulder
Adhesive Capsulitis
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
Osteoarthritis (OA) of the shoulder is a common debilitating condition affecting up to 5% of the general population and as much as 32% of patients over 60 years of age. Clinically, OA is diagnosed by ...
Detailed Description
Amnion injections are commonly performed by community orthopaedic surgeons for many conditions, including osteoarthritis, rotator cuff tears, tendinitis, and others. Human placental tissue has been re...
Eligibility Criteria
Inclusion
- Age 18 years or greater
- Clinical diagnosis of adhesive capsulitis, clinically in the frozen phase at the time of enrollment OR Clinical diagnosis of osteoarthritis of the shoulder.
- Symptoms for 2-6 months
- Failure of conservative management.
- \> 25% reduction in active range of motion in \>= 2/3 planes of motion in the affected shoulder.
- No alternative medical explanation for symptoms
Exclusion
- Alternative explanation for symptoms including neurological disorders, or like conditions
- Pregnancy or desire to become pregnant
- Discretion of the enrolling clinician
- Exclusion in Amnion Injection Group:
- • Intra-articular steroid injection within 6 months of enrollment or surgical intervention in the within 12 months of enrollment in affected shoulder
Key Trial Info
Start Date :
October 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03770546
Start Date
October 30 2021
End Date
January 1 2023
Last Update
November 26 2021
Active Locations (1)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35205