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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06237153
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Marie Badalamente
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Carpometacarpal (CMC) Osteoarthritis

Additional Details

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.

Arms & Interventions

Arms

Experimental: Triamcinolone acetonide extended release suspension injection

Active drug treatment

Placebo Comparator: Saline Placebo Injection

Placebo comparator

Interventions

Drug: - Triamcinolone Acetonide extended release suspension

Active steroid

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Stony Brook Orthopaedics, Stony Brook, New York

Status

Recruiting

Address

Stony Brook Orthopaedics

Stony Brook, New York, 11794

Site Contact

Susan Greco

[email protected]

631-444-3421

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