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| ID | Type | Description | Link |
|---|---|---|---|
| Thumb 202 | Other Identifier | stonyBrookU |
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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:
Current Orthopaedic practice for CMC osteoarthritis involves prescribing thumb braces, oral non steroidal anti inflammatory medications (NSAID's) and/or corticosteroid injection(s) which may provide minimal relief, until symptoms become unbearable, leading to difficult and often complex surgical intervention and extended and painful post operative recovery times. Addition of a safe and effective and longer lasting conservative intervention may decrease pain and increase function in patients affected by CMC osteoarthritis.
Triamcinolone acetonide extended-release (TA-ER) suspension is novel and composed of polylactic-co-glycolic acid microspheres which allows for timed release of the steroid over the course of 12 weeks. It is FDA approved as Zilretta for injection and treatment of osteoarthritis of the knee.
We hypothesize that in a randomized, placebo controlled, double blind study that patients having TA-ER injection to the CMC joint will exhibit decreased pain levels and increased thumb function based on grip, tip and pinch strengths compared to placebo patients. One group of patients will receive CMC joint TA-ER injection and the other saline CMC joint injection. All will be followed for 12 weeks and one longer term follow up visit at 180 days.
Triamcinolone acetonide extended-release (steroid) injection for carpometacarpal (CMC) joint osteoarthritis may provide improved pain relief and thumb function as a conservative treatment for osteoarthritis of the base of the thumb.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triamcinolone acetonide extended release suspension injection | Experimental | Active drug treatment |
|
| Saline Placebo Injection | Placebo Comparator | Placebo comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triamcinolone Acetonide extended release suspension | Drug | Active steroid |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Pain Score | PAIN | Day 1 of injection to six months post injection |
| Measure | Description | Time Frame |
|---|---|---|
| QuickDash Thumb Function Questionnaire | Thumb Function | Day 1 of injection to six months post injection |
| Grip Strength | Grip Strength |
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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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stony Brook Orthopaedics | Recruiting | Stony Brook | New York | 11794 | United States |
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30 patients randomly assigned to drug treatment or saline placebo injection (15 patients in each arm)
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Study coordinator holds randomization code.
| Day 1 of injection to six months post injection |
| Pinch Strength | Pinch Strength | Day 1 of injection to six months post injection |
| Key Strength | Key Strength | Day 1 of injection to six months post injection |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 10, 2025 | Dec 29, 2025 | 1 | ||
| Jan 6, 2026 | Jan 22, 2026 | 2 | ||
| Jan 29, 2026 | Feb 17, 2026 | 3 |
| ID | Term |
|---|---|
| C562760 | Capillary Malformations, Congenital, 1 |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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