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 range
40 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.