Randomized Placebo Controlled Study of Triamcinolone Acetonide Extended Release Injection for Thumb (CMC) Osteoarthritis
Part of paid clinical trials in Stony Brook, New York.
- Sponsor
- Marie Badalamente
- Study ID
- NCT06237153
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Carpometacarpal (CMC) Osteoarthritis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Triamcinolone Acetonide extended release suspension — DRUGActive steroid
Study Details
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.
Key Dates
- Start date
- Nov 21, 2023
- Status verified
- Jan 2024
- Primary completion
- Dec 31, 2025
- Completion
- Dec 31, 2025
Study Design
- Enrollment
- 30 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Triamcinolone acetonide extended release suspension injectionActive drug treatment
- Placebo Comparator: Saline Placebo InjectionPlacebo comparator
Primary Outcome Measure
Visual Analog Pain Score [ Time Frame: Day 1 of injection to six months post injection ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Stony Brook Orthopaedics | Stony Brook | New York | 11794 | Marie Badalamente, PhD (PRINCIPAL_INVESTIGATOR) Samantha I. Muhlrad, MD (PRINCIPAL_INVESTIGATOR) |
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