RecruitingPhase 2

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

United States30 participantsStarted 2023-11-21

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.
✕. 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.

What they're measuring

Visual Analog Pain Score

Timeframe: Day 1 of injection to six months post injection

Trial details

NCT IDNCT06237153

SponsorMarie Badalamente

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-31

View on ClinicalTrials.gov More Carpometacarpal (CMC) Osteoarthritis trials