Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06237153

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

Led by Marie Badalamente · Updated on 2024-02-01

30

Participants Needed

1

Research Sites

110 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female over 18 years of age
  • X-ray diagnosis of carpometacarpal (CMC) osteoarthritis Eaton stages I, II, or III
  • Visual Analog Scale (VAS) pain score of 5 or greater in the affected thumb
  • Ability to give written informed consent and comply with study requirements
  • Willingness to avoid opioid or over-the-counter pain medications during the study, with use logged if non-compliant
Not Eligible

You will not qualify if you...

  • Females who are pregnant, nursing, planning pregnancy during the study, or unwilling to use birth control
  • Any condition or abnormality that may compromise patient safety or study data quality
  • Known or suspected allergy to Triamcinolone Acetonide extended-release or its components
  • Stage IV CMC osteoarthritis
  • Rheumatoid arthritis, septic or gouty arthritis, psoriatic arthritis, thumb joint effusion, DeQuervain's disease, trigger thumb
  • History of CMC joint surgery
  • Serious uncontrolled medical conditions
  • Received hyaluronan or platelet rich plasma injections to affected joint within 6 months
  • Received steroid injection to affected joint within 3 months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Stony Brook Orthopaedics

Stony Brook, New York, United States, 11794

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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