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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	40 Years - 75 Years
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04094298
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Northwell Health
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Russell Camhi
Principal Investigator Affiliation	Northwell Health
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Rotator Cuff Tears, Rotator Cuff Tendinitis, Rotator Cuff Impingement, Injections, Glucocorticoids

Additional Details

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.

Arms & Interventions

Arms

Experimental: Treatment Group

Patients receiving the 32-unit injection of FX006.

Interventions

Drug: - FX006 Injection

One injection of extended release triamcinolone. 32 milligram injection of the extended release triamcinolone in a 75:25 ratio of polylactic-co-glycolic acid (PLGA) microspheres to drug load of 25%. The drug product is reconstituted with diluent containing an isotonic, sterile aqueous solution of sodium chloride, carboxymethylcellulose sodium and polysorbate-80 to form a suspension prior to injection.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Great Neck, New York

Status

Recruiting

Address

Northwell Health Orthopedic Institute at Great Neck

Great Neck, New York, 11021

Site Contact

Caroline Aprigliano

[email protected]

516-640-0317

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