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Taking people in United StatesPhase 2

Slow-release steroid injection for thumb base osteoarthritis compared with placebo

Tests a slow-release steroid injection for pain and function in thumb osteoarthritis.

Key facts

Who runs it
Marie Badalamente
Where
Stony Brook, United StatesSee the site
Trial code
Registry title
Randomized Placebo Controlled Study of Triamcinolone Acetonide Extended Release Injection for Thumb (CMC) Osteoarthritis
Status
Recruiting
Phase
Phase 2
People taking part
30 people, planned
Started
21 Nov 2023
Planned end
31 Dec 2025
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Triamcinolone Acetonide extended release suspension
Record updated
1 February 2024

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with osteoarthritis of the thumb base joint (CMC joint) and thumb pain. It tests an extended release steroid injection against a saltwater placebo injection.

Age
Over 18 years
Sex
Male or female
Disease stage
CMC osteoarthritis seen on X-ray, Eaton stage I, II or III. Pain score (VAS) in the affected thumb of 5 or greater.
Earlier treatment
No hyaluronan or platelet rich plasma (PRP) injections into the affected CMC joint within 6 months. No steroid injection into that joint within 3 months. No past surgical reconstruction of the CMC joint. Opioids and over the counter pain medicines are not allowed during the study.

Main reasons for not taking part

  • Pregnant or nursing, planning a pregnancy, or unwilling to use birth control during the study
  • Stage IV CMC osteoarthritis
  • Rheumatoid, septic, gouty or psoriatic arthritis, fluid in the thumb joint, DeQuervain's disease or trigger thumb
  • Known or suspected allergy to TA-ER or triamcinolone acetonide
  • Terminal illness, or a chronic, serious, uncontrolled medical condition

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
  • Known or suspected hypersensitivity to TA-ER (or component of TA-ER), triamcinolone acetonide
  • Stage IV CMC osteoarthritis is excluded. Rationale for exclusion of stage IV is that these patients are most likely surgical candidates due to severe joint damage. Other exclusion criteria include rheumatoid arthritis, septic or gouty arthritis or psoriatic arthritis, thumb joint effusion, DeQuervain's disease, trigger thumb or history of CMC joint surgical reconstruction, or terminal or chronic and serious, uncontrolled associated medical conditions. Patients who have received hyaluronan or platelet rich plasma (PRP) injections to the affected CMC joint within 6 months will be excluded. Patients who have received a steroid injection to the affected CMC joint within 3 months will be excluded
  • Females who are pregnant or nursing or plan to become pregnant during the study; women who plan to conceive during the study; or unwilling to practice birth control during participation in the study

Where in United States

  • Stony Brook OrthopaedicsStony Brook, United StatesContact: Susan GrecoTaking people

About the trial

What the trial wants to find out

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:

Read full original descriptionShow less

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.

The 2 groups in the trial

  • Triamcinolone acetonide extended release suspension injectionTreatment being tested

    Active drug treatment

    Treatment: Triamcinolone Acetonide extended release suspension

  • Saline Placebo InjectionPlacebo, for comparison

    Placebo comparator

    Treatment: Triamcinolone Acetonide extended release suspension

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Randomized Placebo Controlled Study of Triamcinolone Acetonide Extended Release Injection for Thumb (CMC) Osteoarthritis
Plain-language title
Slow-release steroid injection for thumb base osteoarthritis compared with placeboGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
1 February 2024