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

Northwell Health

Status and phase: Active, not recruiting; Phase 3

Conditions: Rotator Cuff Impingement; Rotator Cuff Tendinitis; Glucocorticoids; Injections; Rotator Cuff Tears

Treatments: Drug: FX006 Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04094298

19-0258

Details and patient eligibility

About

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.

Full 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 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. Patients will have normal Xrays or Xrays indicative of chronic cuff tearing and a musculoskeletal ultrasound indicating an intact rotator cuff, partial cuff tearing or cuff tear. Patients will undergo an ultrasound guided injection of TA-ER into the subacromial space from a lateral access point at the time of the examination. They will be monitored for any immediate adverse effects. Patient reported outcomes measures will be recorded with online questionnaires which include a Visual Analog Scale (VAS), Single assessment numeric evaluation (SANE), Veteran's Rand 12 (VR-12) and American Shoulder and Elbow Scale (ASES) and will be recorder pre-treatment and at 2, 4, 8 and 12 and 24 weeks post treatment. Patients will be asked to follow up for an in person evaluation at 4 weeks, 12 weeks and 24 weeks post injection.

Enrollment: 65 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

65 participants in 1 patient group

Treatment Group

Experimental group

Description:

Patients receiving the 32-unit injection of FX006.

Treatment:

Drug: FX006 Injection