Status:
ACTIVE_NOT_RECRUITING
Use of Extended Release Triamcinolone in the Treatment of Rotator Cuff Disease
Lead Sponsor:
Northwell Health
Conditions:
Rotator Cuff Tears
Rotator Cuff Tendinitis
Eligibility:
All Genders
40-75 years
Phase:
PHASE3
Brief 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 wil...
Detailed Description
The purpose of this study is to assess the safety and efficacy of TA-ER in the treatment of rotator cuff disease. The study will enroll 65 patients in a longitudinal case series level IV study using e...
Eligibility Criteria
Inclusion
- 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.
- Willing to abstain from use of NSAIDs
Exclusion
- 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.
Key Trial Info
Start Date :
July 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2025
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT04094298
Start Date
July 15 2019
End Date
January 31 2025
Last Update
December 27 2024
Active Locations (1)
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1
Northwell Health Orthopedic Institute at Great Neck
Great Neck, New York, United States, 11021