RECRUITING

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

Conditions

Carpometacarpal (CMC) Osteoarthritis Thumb Osteoarthritis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-11-21

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06237153

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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.

Inclusion Criteria

Exclusion 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

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.

Contacts and Locations

Study Locations (Sites)

Stony Brook Orthopaedics

Stony Brook, New York, 11794

United States

Collaborators and Investigators

Sponsor: Marie Badalamente

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-21

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2023-11-21

Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

Thumb Osteoarthritis

Additional Relevant MeSH Terms

Carpometacarpal (CMC) Osteoarthritis