Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2025-12-26 @ 3:57 AM
Study NCT ID:
NCT03147118
Status:
COMPLETED
Last Update Posted:
2024-09-24
First Post:
2017-05-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluating Palpation Guided Injections in Trapeziometacarpal Arthritis
Sponsor:
Prisma Health-Upstate
Organization:
Study Overview
Official Title:
Evaluating Palpation Guided Injections in Trapeziometacarpal Arthritis
Status:
COMPLETED
Status Verified Date:
2024-09
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 objective of this study is to evaluate the accuracy of trapeziometacarpal injections using palpation alone. The importance of this study is one of education, cost containment, and decreased risk to the patient. If it can be shown that the accuracy of trapeziometacarpal injections using palpation alone is similar to the reported accuracy of ultrasound and fluoroscopy, then these guided techniques may not be needed.
Detailed Description:
The objective of this study is to evaluate the accuracy of trapeziometacarpal injections using palpation alone. If it can be shown that the accuracy of trapeziometacarpal injections using palpation alone is similar to the reported accuracy of ultrasound and fluoroscopy, then fluoroscopy and ultrasound guided techniques may not be needed. Due to the expenses associated with medications and testing, it is important to not accrue unnecessary costs if there is no perceived benefit. The investigators plan to enroll 50 patients presenting with trapeziometacarpal joint arthritis who agree to participate. These participants will undergo an injection technique consisting of palpating the base of the thumb and placing the needle into the trapeziometacarpal joint without the guidance of ultrasound or fluoroscopy. Contrast dye will be included in the standard injection of lidocaine and corticosteroid. After injection, the participant will have 2 fluoroscopy views of the thumb. The images will not be evaluated for injection accuracy prior to the patient leaving the clinic, so as to not introduce any bias by the treating physician. These images will be blindly reviewed by three investigators at a later date, and determined by consensus if there is contrast material in the joint. The accuracy rate can then be compared to data regarding accuracy of fluoroscopic and ultrasound guided injections of the trapeziometacarpal joint. If there is a similar accuracy rate between modalities, it can be concluded that ultrasound may not be worth the added cost to the patient and fluoroscopy may not be worth the added cost or radiation to the participant. Additionally, participants will be contacted at 6 weeks post injection to evaluate post-injection arthritis symptoms.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
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?: