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

December 24, 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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
65

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • New York
      • Great Neck, New York, United States, 11021
        • Northwell Health Orthopedic Institute at Great Neck

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment Group
Patients receiving the 32-unit injection of FX006.
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.
Other Names:
  • No other interventions

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Northwell Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 15, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 10, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 7, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 18, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 24, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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