Injection treatment for thumb osteoarthritis

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

This study is testing if a special steroid injection can help people with thumb arthritis feel less pain and use their thumbs better compared to a placebo injection.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Stony Brook University (Academic / other)
• Locations: 1 site (Stony Brook, New York)
• Trial ID: NCT06237153 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of a timed release steroid injection, Triamcinolone Acetonide extended release (TA-ER), in treating carpometacarpal (CMC) joint osteoarthritis in the thumb. Participants will receive either the TA-ER injection or a placebo saline injection, followed by assessments of pain and thumb function over a 12-week period. The goal is to determine if the steroid injection can significantly reduce pain and improve thumb functionality compared to the placebo. This approach aims to provide a safer and longer-lasting conservative treatment option for patients suffering from CMC osteoarthritis.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with a confirmed diagnosis of CMC osteoarthritis and a pain score of 5 or greater.

Not a fit: Patients with severe hypersensitivity to the treatment or those with certain medical conditions that compromise safety may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide significant pain relief and improved thumb function for patients with CMC osteoarthritis.

How similar studies have performed: While this approach is novel for CMC osteoarthritis, similar steroid injection methods have shown success in treating other types of osteoarthritis.

Eligibility criteria

Inclusion Criteria:

1. Male or female \> 18 years of age.
2. X ray diagnosis of CMC osteoarthritis Eaton stages I, II or III.
3. VAS pain score in affected thumb of 5 or greater.
4. Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
5. 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

Exclusion Criteria:

1. 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.
2. 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.
3. Known or suspected hypersensitivity to TA-ER (or component of TA-ER), triamcinolone acetonide.
4. 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.

Where this trial is running

Stony Brook, New York

• Stony Brook Orthopaedics — Stony Brook, New York, United States (Recruiting)

Conditions Carpometacarpal Osteoarthritis; Thumb Osteoarthritis