- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04094298
Use of Extended Release Triamcinolone in the Treatment of Rotator Cuff Disease
January 2, 2024 updated by: Northwell Health
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 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.
Study Type
Interventional
Enrollment (Estimated)
65
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hamna Muzammil
- Email: hmuzammil@northwell.edu
Study Contact Backup
- Name: Caroline Aprigliano
- Phone Number: 5166400317
- Email: caprigliano@northwell.edu
Study Locations
-
-
New York
-
Great Neck, New York, United States, 11021
- Recruiting
- Northwell Health Orthopedic Institute at Great Neck
-
Contact:
- Caroline Aprigliano
- Phone Number: 516-640-0317
- Email: caprigliano@northwell.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
- Willing to abstain from use of NSAIDs
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment Group
Patients receiving the 32-unit injection of FX006.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of adverse events
Time Frame: 24 weeks
|
Assess the overall safety extended release triamcinolone in acetate (TA-ER/FX006) in patient with rotator cuff disease.
Safety is evaluated on the basis of incidence of adverse events (AE).
These would be reported by the patient or discovered by the investigator from the following measure below: VAS (Visual Analogue Scale) is a scale to measure patient's pain.
SANE (Single Assessment Numeric Evaluation) a scale of 0 to 100 that patients rate their joint function, with 100 being normal function.
VR12 (Veterans RAND 12 Item Health Survey) is a patient-reported measure of a patient's overall health.
ASES (American Shoulder and Elbow Surgeons Standardized Shoulder Assessment) is a survey which measures function and pain in the shoulder.
Surveys could indicate an AE if there was increasing pain or worsening function which would not be expected.
This would direct the investigator into further physical exam and inquiry on possible injuries or any other AE.
Outcomes will not be aggregated.
|
24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in shoulder pain as assessed by VAS
Time Frame: 24 weeks
|
Assess changes in shoulder pain.
Change in shoulder pain as measured by VAS.
The VAS (Visual Analogue Scale for pain) is a continuous scale to measure patient's pain.
The scale is from 0 to 100 with 100 being the worst pain and 0 being no pain.
|
24 weeks
|
Change in shoulder function as assessed by SANE
Time Frame: 24 weeks
|
Assess changes in shoulder function.
Change in shoulder function as measured by SANE.
SANE (Single Assessment Numeric Evaluation) is a scale of 0 to 100 that patients rate their knee function, with 100 being normal function and 0 being no function.
|
24 weeks
|
Change in shoulder function as assessed by VR-12
Time Frame: 24 weeks
|
health.
It includes 12 questions which correspond to seven health domains: general health, physical function, limitations due to physical and emotional problems, bodily pain, energy level, social functioning, and mental health.
There are two scores from the VR-12, a Mental Component Score and a Physical Component Score.
The scores are reported as Z-scores (number of standard deviations away from population average).
The average score for the United States population is 50 and 1 standard deviation corresponds to 10 points.
|
24 weeks
|
Change in shoulder function and pain as assessed by ASES
Time Frame: 24 weeks
|
ASES (American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form) is a patient reported questionnaire which measures function and pain in the shoulder.
This is a 100 point scale that combines 50 points from pain and 50 points from function.
There are 2 sections to the form: pain and activities of daily living.
The pain section has 4 yes or no questions regarding timing of pain and pain medication, and 1 question involving a VAS scale from 0 (no pain) to 10 (worst pain).
The activities of daily living section has 10 questions and is ranked on a 0 (unable to perform) to 3 (no difficulty performing) scale.
|
24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Russell Camhi, Northwell Health
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Tashjian RZ, Deloach J, Porucznik CA, Powell AP. Minimal clinically important differences (MCID) and patient acceptable symptomatic state (PASS) for visual analog scales (VAS) measuring pain in patients treated for rotator cuff disease. J Shoulder Elbow Surg. 2009 Nov-Dec;18(6):927-32. doi: 10.1016/j.jse.2009.03.021. Epub 2009 Jun 16.
- Gaujoux-Viala C, Dougados M, Gossec L. Efficacy and safety of steroid injections for shoulder and elbow tendonitis: a meta-analysis of randomised controlled trials. Ann Rheum Dis. 2009 Dec;68(12):1843-9. doi: 10.1136/ard.2008.099572. Epub 2008 Dec 3.
- Tashjian RZ, Deloach J, Green A, Porucznik CA, Powell AP. Minimal clinically important differences in ASES and simple shoulder test scores after nonoperative treatment of rotator cuff disease. J Bone Joint Surg Am. 2010 Feb;92(2):296-303. doi: 10.2106/JBJS.H.01296.
- Conaghan PG, Hunter DJ, Cohen SB, Kraus VB, Berenbaum F, Lieberman JR, Jones DG, Spitzer AI, Jevsevar DS, Katz NP, Burgess DJ, Lufkin J, Johnson JR, Bodick N; FX006-2014-008 Participating Investigators. Effects of a Single Intra-Articular Injection of a Microsphere Formulation of Triamcinolone Acetonide on Knee Osteoarthritis Pain: A Double-Blinded, Randomized, Placebo-Controlled, Multinational Study. J Bone Joint Surg Am. 2018 Apr 18;100(8):666-677. doi: 10.2106/JBJS.17.00154.
- Jain NB. Do These Crystals Really Sparkle?: Commentary on an article by Philip G. Conaghan, MBBS, PhD, FRACP, FRCP, et al.: "Effects of a Single Intra-Articular Injection of a Microsphere Formulation of Triamcinolone Acetonide on Knee Osteoarthritis Pain. A Double-Blinded, Randomized, Placebo-Controlled, Multinational Study". J Bone Joint Surg Am. 2018 Apr 18;100(8):e56. doi: 10.2106/JBJS.17.01520. No abstract available.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 15, 2019
Primary Completion (Estimated)
December 1, 2024
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
August 7, 2019
First Submitted That Met QC Criteria
September 17, 2019
First Posted (Actual)
September 18, 2019
Study Record Updates
Last Update Posted (Actual)
January 5, 2024
Last Update Submitted That Met QC Criteria
January 2, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Wounds and Injuries
- Joint Diseases
- Musculoskeletal Diseases
- Muscular Diseases
- Rupture
- Shoulder Injuries
- Tendon Injuries
- Rotator Cuff Injuries
- Tendinopathy
- Shoulder Impingement Syndrome
- Physiological Effects of Drugs
- Anti-Inflammatory Agents
- Immunosuppressive Agents
- Immunologic Factors
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- FX006
Other Study ID Numbers
- 19-0258
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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