Recruiting
Phase 2

Steroid Injection

Sponsor:

Marie Badalamente

Code:

NCT06237153

Conditions

Carpometacarpal (CMC) Osteoarthritis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Triamcinolone Acetonide extended release suspension

Study Details

Brief 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.

Conditions

Carpometacarpal (CMC) Osteoarthritis

Study ID

NCT06237153

Start date

Nov 21, 2023

Status verified date

Jan, 2024

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Triamcinolone acetonide extended release suspension injection

Active drug treatment

placebo comparator: Saline Placebo Injection

Placebo comparator

Interventions

Triamcinolone Acetonide extended release suspension

Active steroid

Primary outcome measure

  • Visual Analog Pain Score [ Time Frame: Day 1 of injection to six months post injection ]

Central Contacts and Locations

Locations

Stony Brook Orthopaedics

Recruiting

Stony Brook, New York, United States, 11794

Contacts

Principal Investigator:

Marie Badalamente, PhD

More Information

Sponsor

Marie Badalamente

Last update posted

Feb 1, 2024

Last verified

Jan, 2024

Keywords

  • Thumb Osteoarthritis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Marie Badalamente on 2024-02-01.