Randomized Placebo Controlled Study of Triamcinolone Acetonide Extended Release Injection for Thumb (CMC) Osteoarthritis
Marie Badalamente
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.
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 an…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 n…
Interventions
- DrugTriamcinolone Acetonide extended release suspension
Active steroid
Location
- Stony Brook OrthopaedicsStony Brook, New York