Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:29 PM
Study NCT ID:
NCT03583151
Status:
UNKNOWN
Last Update Posted:
2018-07-11
First Post:
2018-06-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Corticosteroid vs. Amniotic Fluid Injections in Patients With Trigger Finger
Sponsor:
J&M Shuler
Organization:
Study Overview
Official Title:
Injection With Amniotic Fluid Versus Corticosteroid in Patients With Stenosing Tenosynovitis: a Randomized, Blinded Trial
Status:
UNKNOWN
Status Verified Date:
2018-06
Last Known Status:
ENROLLING_BY_INVITATION
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 proposed study aims to investigate whether amniotic fluid injections are a better alternative to corticosteroid injections as a conservative treatment for stenosing tenosynovitis. Based on results from our most recent pilot study exploring patient outcomes after receiving an amnion injection, we were able to observe symptom resolution in more than half of the study population. Adverse events were extremely rare and not related to study participation. Given the numerous occurrences of successful symptom resolution, the next step is to compare patient outcomes to those of patients who receive the standard steroid injection. This study will compare outcome measurements of patients who receive amnion injections to those who receive steroid injections.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: