Use of Extended Release Triamcinolone in the Treatment of Rotator Cuff Disease

• Status: Recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwell Health
• Collaborators: Louis McIntyre MD; Russell Camhi, DO
• Treatments: FX006; Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

Criteria

Inclusion Criteria:

1. Male or female between the ages of 40-75 years old.

2. Able and willing to give written informed consent in accordance with the IRB.

3. Read and Speak English.

4. History indicative of rotator cuff disease.

5. Physical exam consistent with rotator cuff disease.

6. All patients will have AP and Outlet X ray views.

7. X rays will be normal or indicative of chronic RTC tearing

8. Musculoskeletal Ultrasound indicating intact RTC, full thickness tears, or large and massive cuff tears in older, sedentary individuals.

9. Willing to abstain from use of NSAIDs

Exclusion Criteria:

1. 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.

2. 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.

3. Known or suspected hypersensitivity to FX006 (or component of FX006), triamcinolone acetonide.