Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06237153
Status:
RECRUITING
Last Update Posted:
2024-02-01
First Post:
2024-01-24
Brief Title:
Randomized Placebo Controlled Study of Triamcinolone Acetonide Extended Release Injection for Thumb CMC Osteoarthritis
Sponsor:
Marie Badalamente
Organization:
Stony Brook University
Study Overview
Official Title:
Randomized Placebo Controlled Study of Triamcinolone Acetonide Extended Release Injection for Thumb CMC Osteoarthritis
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
Current Orthopaedic practice for CMC osteoarthritis involves prescribing thumb braces oral non steroidal anti inflammatory medications NSAIDs andor corticosteroid injections 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Thumb 202 | OTHER | stonyBrookU | None |