Use of Extended Release Triamcinolone in the Treatment of Rotator Cuff Disease (NCT04094298) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Use of Extended Release Triamcinolone in the Treatment of Rotator Cuff Disease
United States65 participantsStarted 2019-07-15
Plain-language 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.
Who can participate
Age range40 Years – 75 Years
SexALL
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Inclusion criteria
✓. Male or female between the ages of 40-75 years old.
✓. Able and willing to give written informed consent in accordance with the IRB.
✓. Read and Speak English.
✓. History indicative of rotator cuff disease.
✓. Physical exam consistent with rotator cuff disease.
✓. All patients will have AP and Outlet X ray views.
✓. X rays will be normal or indicative of chronic RTC tearing
✓. Musculoskeletal Ultrasound indicating intact RTC, full thickness tears, or large and massive cuff tears in older, sedentary individuals.
Exclusion criteria
✕. Females who are pregnant or nursing or plan to become pregnant during the study; men who plan to conceive during the study; or unwilling to practice birth control during participation in the study.
. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
✕. Known or suspected hypersensitivity to FX006 (or component of FX006), triamcinolone acetonide.