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

NCT ID: NCT04094298

Last Updated: 2024-12-27

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-15
• Study Completion Date: 2025-01-31

Brief 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.

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Group

Patients receiving the 32-unit injection of FX006.

Group Type: EXPERIMENTAL

FX006 Injection

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

No other interventions

Eligibility 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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwell Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Russell Camhi

Role: PRINCIPAL_INVESTIGATOR

Northwell Health

Locations

Northwell Health Orthopedic Institute at Great Neck

Great Neck, New York, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 29664853 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19054817 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20124055 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19535272 (View on PubMed)

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.

Reference Type: RESULT

PMID: 29664865 (View on PubMed)

Other Identifiers

19-0258

Identifier Type: -

Identifier Source: org_study_id