ZILRETTA™ for Treatment of Idiopathic Adhesive Capsulitis

NCT04831255 | Terminated Phase 1 FDA Drug

• 1 other identifier: 21584
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

Adhesive capsulitis is a fairly common orthopedic condition that causes pain and loss of range of motion. There are a variety of ways to treat adhesive capsulitis, one of them being an intra-articular steroid injection. This is done to help decrease the inflammatory response caused by adhesive capsulitis. In this study, all participants will receive an intra-articular glenohumeral injection of ZILRETTA and will be followed up with at four time points over 1 year to observe pain, function and range of motion following the injection.

Conditions

Adhesive Capsulitis; Frozen Shoulder; Adhesive Capsulitis of Shoulder

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale Score

  Pain rating on a scale of 0-10, higher numbers indicating a worse outcome

  6 months after injection

Secondary Outcomes (10)

• American Shoulder and Elbow Society Score

  6 months after injection

• American Shoulder and Elbow Society Score

  12 months after injection

• PROMIS Physical Function Score

  6 months after injection

• PROMIS Physical Function Score

  12 months after injection

• Triplanar Range of Motion

  1 month after injection

Study Arms (1)

ZILRETTA

EXPERIMENTAL

Single injection of triamcinolone acetonide extended-release injectable suspension, injected in the glenohumeral joint under ultrasound guidance.

Drug: triamcinolone acetonide extended-release injectable suspension

Interventions

triamcinolone acetonide extended-release injectable suspension DRUG

ZILRETTA (triamcinolone acetonide extended-release injectable suspension) injection in the glenohumeral joint administered under ultrasound guidance.

Also known as: ZILRETTA

ZILRETTA

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of idiopathic adhesive capsulitis (onset \<6 months prior)
• Pain rating of 5 or greater out of 10 on 0-10 scale at time of enrollment
• Willing to come on site for follow up evaluations at 1 month, 3 months, 6 months, and 12 months after the injection

You may not qualify if:

• Active workers compensation case
• Known psychiatric disorders under active treatment
• Uncontrolled diabetes (defined as diabetic ketoacidosis, severe peripheral neuropathy, ophthalmologic or renal manifestations)
• Diagnosed osteoarthritis of the ipsilateral or contralateral shoulder
• Painful joint condition in another part of the body affecting perceived pain

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Bursitis

Interventions

Triamcinolone

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Brian Werner, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Orthopaedic Surgery

Model Details: All subjects receive the ZILRETTA injection

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: April 5, 2021
• Study Start: June 21, 2019
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)