Randomized Placebo Controlled Study of Triamcinolone Acetonide Extended Release Injection for Thumb (CMC) Osteoarthritis

NCT ID: NCT06237153

Last Updated: 2024-02-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-21
• Study Completion Date: 2025-12-31

Brief Summary

The goal of this study is to investigate if a timed release steroid injection may be beneficial in treating carpometacarpal (CMC) joint (thumb) osteoarthritis. The main questions to be answered are:

1. does the steroid injection substantially reduce pain in the thumb

2. does the steroid injection help to increase thumb function Participants will be asked to undergo a thumb CMC joint injection and to attend follow up visits to assess pain and thumb function.

Detailed Description

Current Orthopaedic practice for CMC osteoarthritis involves prescribing thumb braces, oral non steroidal anti inflammatory medications (NSAID's) and/or corticosteroid injection(s) which may provide minimal relief, until symptoms become unbearable, leading to difficult and often complex surgical intervention and extended and painful post operative recovery times. Addition of a safe and effective and longer lasting conservative intervention may decrease pain and increase function in patients affected by CMC osteoarthritis.

Triamcinolone acetonide extended-release (TA-ER) suspension is novel and composed of polylactic-co-glycolic acid microspheres which allows for timed release of the steroid over the course of 12 weeks. It is FDA approved as Zilretta for injection and treatment of osteoarthritis of the knee.

We hypothesize that in a randomized, placebo controlled, double blind study that patients having TA-ER injection to the CMC joint will exhibit decreased pain levels and increased thumb function based on grip, tip and pinch strengths compared to placebo patients. One group of patients will receive CMC joint TA-ER injection and the other saline CMC joint injection. All will be followed for 12 weeks and one longer term follow up visit at 180 days.

Triamcinolone acetonide extended-release (steroid) injection for carpometacarpal (CMC) joint osteoarthritis may provide improved pain relief and thumb function as a conservative treatment for osteoarthritis of the base of the thumb.

Conditions

Carpometacarpal (CMC) Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Triamcinolone acetonide extended release suspension injection

Active drug treatment

Group Type: EXPERIMENTAL

Triamcinolone Acetonide extended release suspension

Intervention Type: DRUG

Active steroid

Saline Placebo Injection

Placebo comparator

Group Type: PLACEBO_COMPARATOR

Triamcinolone Acetonide extended release suspension

Intervention Type: DRUG

Active steroid

Interventions

Triamcinolone Acetonide extended release suspension

Active steroid

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male or female > 18 years of age.

2. X ray diagnosis of CMC osteoarthritis Eaton stages I, II or III.

3. VAS pain score in affected thumb of 5 or greater.

4. Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.

5. Willing to abstain from use of the following protocol-restricted medications during the study to be kept in a log if non compliant.

• Opioid or over the counter medications for pain for the study duration

Exclusion Criteria

1. Females who are pregnant or nursing or plan to become pregnant during the study; women 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 TA-ER (or component of TA-ER), triamcinolone acetonide.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Marie Badalamente

OTHER

Sponsor Role: lead

Responsible Party

Marie Badalamente

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Stony Brook Orthopaedics

Stony Brook, New York, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Susan Greco

Role: primary

Susan.Greco@stonybrookmedicine.edu

631-444-3421

Other Identifiers

Thumb 202

Identifier Type: OTHER

Identifier Source: secondary_id

Thumb 202

Identifier Type: -

Identifier Source: org_study_id