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 — DRUG
    Active 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 injection
    Active drug treatment
  • Placebo Comparator: Saline Placebo Injection
    Placebo comparator

Primary Outcome Measure

Visual Analog Pain Score [ Time Frame: Day 1 of injection to six months post injection ]

Locations (1)

FacilityCityStateZIPSite coordinators
Stony Brook OrthopaedicsStony BrookNew York11794
Susan Greco
631-444-3421
Marie Badalamente, PhD (PRINCIPAL_INVESTIGATOR)
Samantha I. Muhlrad, MD (PRINCIPAL_INVESTIGATOR)

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