Amnion-Based Injections in the Shoulder
Osteoarthritis of the Shoulder, Adhesive Capsulitis
About this trial
This is an interventional treatment trial for Osteoarthritis of the Shoulder
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- University of Alabama at Birmingham
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Active Comparator
Experimental
Active Comparator
Osteoarthritis - Amnion Injection
Osteoarthritis - Betamethasone Injection
Adhesive Capsulitis - Amnion Injection
Adhesive Capsulitis - Betamethasone Injection
BioDRestore Elemental Tissue Matrix is a morselized, flowable tissue allograft derived from human amniotic tissues.
Betamethasone Sodium Phosphate and Betamethasone Acetate injection (To clarify, this is one formulation/injected solution, not separate solutions/interventions)
BioDRestore Elemental Tissue Matrix is a morselized, flowable tissue allograft derived from human amniotic tissues.
Betamethasone Sodium Phosphate and Betamethasone Acetate injection (To clarify, this is one formulation/injected solution, not separate solutions/interventions)