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Use of Extended Release Triamcinolone in the Treatment of Rotator Cuff Disease
Sponsor: Northwell Health
Summary
The primary objective of this study is to assess the overall safety and general tolerability of extended release triamcinolone acetate (TA-ER/FX006) in patient with rotator cuff disease. The study will enroll 65 patients, aged 40-75 years old, in a longitudinal case series level IV study using extended release triamcinolone to treat shoulder pain from rotator cuff disease. Inclusion criteria will be shoulder pain without a history of trauma and physical exam consistent with rotator cuff tendinitis, impingement syndrome or rotator cuff tear.
Key Details
Gender
All
Age Range
40 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
65
Start Date
2019-07-15
Completion Date
2025-01-31
Last Updated
2024-12-27
Healthy Volunteers
No
Conditions
Interventions
FX006 Injection
One injection of extended release triamcinolone. 32 milligram injection of the extended release triamcinolone in a 75:25 ratio of polylactic-co-glycolic acid (PLGA) microspheres to drug load of 25%. The drug product is reconstituted with diluent containing an isotonic, sterile aqueous solution of sodium chloride, carboxymethylcellulose sodium and polysorbate-80 to form a suspension prior to injection.
Locations (1)
Northwell Health Orthopedic Institute at Great Neck
Great Neck, New York, United States