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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Male or female \> 18 years of age.

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

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

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

• 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

Locations
United States
New York
Stony Brook Orthopaedics
RECRUITING
Stony Brook
Time Frame
Start Date: 2023-11-21
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 30
Treatments
Experimental: Triamcinolone acetonide extended release suspension injection
Active drug treatment
Placebo_comparator: Saline Placebo Injection
Placebo comparator
Related Therapeutic Areas
Sponsors
Leads: Marie Badalamente

This content was sourced from clinicaltrials.gov