Ignite Creation Date:
2024-10-25 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06514716
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-17
Brief Title:
Intra-articular Corticosteroid Injection in GAE for Knee Knee Osteoarthritis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Role of Intra-articular Corticosteroid Injection in Geniculate Artery Embolization for Knee Osteoarthritis A Comparative Study
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to investigate the effectiveness and safety of intra-articular corticosteroid injection IACI in alleviating post-procedural pain and improving early outcomes in patients undergoing geniculate artery embolization GAE for knee osteoarthritis OA The main questions it aims to answer are
Does intra-articular corticosteroid injection reduce pain levels post-procedure compared to GAE alone
Does the combination of GAE and IACI improve functional outcomes and patient-reported outcomes compared to GAE alone
Investigators will compare patients receiving GAE with IACI to those receiving GAE alone to see if the addition of IACI provides superior pain relief and functional improvement
Participants will
Undergo geniculate artery embolization with or without intra-articular corticosteroid injection
Have their pain levels assessed using the Visual Analog Scale VAS at 1 week 2 weeks and 4 weeks post-procedure
Complete functional outcome assessments using the KOOS and WOMAC scores
Report any adverse events throughout the study period
Does intra-articular corticosteroid injection reduce pain levels post-procedure compared to GAE alone
Does the combination of GAE and IACI improve functional outcomes and patient-reported outcomes compared to GAE alone
Investigators will compare patients receiving GAE with IACI to those receiving GAE alone to see if the addition of IACI provides superior pain relief and functional improvement
Participants will
Undergo geniculate artery embolization with or without intra-articular corticosteroid injection
Have their pain levels assessed using the Visual Analog Scale VAS at 1 week 2 weeks and 4 weeks post-procedure
Complete functional outcome assessments using the KOOS and WOMAC scores
Report any adverse events throughout the study period
Detailed Description:
This study is a prospective randomized comparative trial designed to evaluate the role of intra-articular corticosteroid injection IACI in patients undergoing geniculate artery embolization GAE for knee osteoarthritis OA The trial will enroll adult participants diagnosed with knee OA who are eligible for GAE
Participants will be randomized into two groups Group A GAE with IACI and Group B GAE alone The primary outcome measure will be the Visual Analog Scale VAS pain scores at 1 week 2 weeks and 4 weeks post-procedure Secondary outcome measures will include functional improvement assessed using the Knee Injury and Osteoarthritis Outcome Score KOOS and the Western Ontario and McMaster Universities Arthritis Index WOMAC patient-reported outcomes and the incidence of adverse events
The study aims to determine whether the addition of IACI to GAE provides better pain relief and functional outcomes compared to GAE alone Data will be collected at baseline and specified time points post-procedure and statistical analysis will be conducted to compare the outcomes between the two groups This study is conducted in accordance with the principles of the Declaration of Helsinki and has received ethical approval from the institutional review board Informed consent will be obtained from all participants before enrollment
Participants will be randomized into two groups Group A GAE with IACI and Group B GAE alone The primary outcome measure will be the Visual Analog Scale VAS pain scores at 1 week 2 weeks and 4 weeks post-procedure Secondary outcome measures will include functional improvement assessed using the Knee Injury and Osteoarthritis Outcome Score KOOS and the Western Ontario and McMaster Universities Arthritis Index WOMAC patient-reported outcomes and the incidence of adverse events
The study aims to determine whether the addition of IACI to GAE provides better pain relief and functional outcomes compared to GAE alone Data will be collected at baseline and specified time points post-procedure and statistical analysis will be conducted to compare the outcomes between the two groups This study is conducted in accordance with the principles of the Declaration of Helsinki and has received ethical approval from the institutional review board Informed consent will be obtained from all participants before enrollment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None