Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06514703
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-17
Brief Title:
Comparative Study of CT and Fluoroscopic Guided Genicular Nerve Ablation in the Treatment of Knee Osteoarthritis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparative Study of CT and Fluoroscopic Guided Genicular Nerve Ablation in the Treatment of Knee Osteoarthritis
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 study is to evaluate the comparative effectiveness of CT-guided and fluoroscopic-guided genicular nerve ablation in reducing knee pain and improving function in adults diagnosed with knee osteoarthritis refractory to conservative treatment
The main questions it aims to answer are
Does CT-guided genicular nerve ablation provide superior pain relief compared to fluoroscopic-guided genicular nerve ablation
Is there a significant difference in functional improvement between the two techniques
Researchers will compare the outcomes between the CT-guided and fluoroscopic-guided groups to determine which method achieves better pain relief functional enhancement safety profile and patient satisfaction
Participants will
Undergo either CT-guided or fluoroscopic-guided genicular nerve ablation
Attend scheduled follow-up visits to assess pain levels knee function and any adverse events
Complete standardized questionnaires to provide feedback on pain relief functional improvement and overall satisfaction with the procedure
The main questions it aims to answer are
Does CT-guided genicular nerve ablation provide superior pain relief compared to fluoroscopic-guided genicular nerve ablation
Is there a significant difference in functional improvement between the two techniques
Researchers will compare the outcomes between the CT-guided and fluoroscopic-guided groups to determine which method achieves better pain relief functional enhancement safety profile and patient satisfaction
Participants will
Undergo either CT-guided or fluoroscopic-guided genicular nerve ablation
Attend scheduled follow-up visits to assess pain levels knee function and any adverse events
Complete standardized questionnaires to provide feedback on pain relief functional improvement and overall satisfaction with the procedure
Detailed Description:
Background
Knee osteoarthritis is a chronic degenerative joint disease affecting millions worldwide characterized by progressive cartilage loss inflammation and pain Despite various treatment options such as intra-articular corticosteroids viscosupplementation and PRP injections many patients experience inadequate relief or adverse effects Genicular nerve ablation has emerged as a promising minimally invasive technique to alleviate chronic knee pain by interrupting pain transmission from the genicular nerves to the central nervous system
Rationale
The rationale for comparing CT-guided and fluoroscopic-guided genicular nerve ablation lies in optimizing treatment outcomes while ensuring patient safety and satisfaction CT-guided procedures offer unparalleled precision in nerve localization potentially enhancing the accuracy of nerve ablation and improving clinical outcomes However this method involves higher radiation exposure compared to fluoroscopic guidance which utilizes real-time imaging with lower radiation doses Understanding which approach provides superior pain relief functional improvement and patient satisfaction is crucial for optimizing treatment protocols and guiding clinical practice
Objectives
Primary Objective
1 Evaluate the efficacy of CT-guided and fluoroscopic-guided genicular nerve ablation in reducing knee pain as measured by the visual analog scale VAS at 3 months post-procedure
Secondary Objectives
1 Evaluate changes in knee function using the Western Ontario and McMaster Universities Osteoarthritis Index WOMAC a validated scoring system specifically designed for osteoarthritis
2 Monitor and document any procedure-related adverse events to compare the safety profiles of both techniques
3 Evaluate patient satisfaction using the structured Patient Satisfaction Questionnaire PSQ
Study Design
This study is a randomized controlled trial RCT aimed at evaluating the comparative effectiveness of CT-guided versus fluoroscopic-guided genicular nerve ablation Eligible patients will be randomly allocated to one of the two treatment groups Given the specific nature of the interventions it may not be possible to blind participants or operators however to minimize potential bias outcome assessors will be blinded to the treatment assignments
Participants
Inclusion Criteria Adults aged 45-80 diagnosed with knee osteoarthritis refractory to conservative treatment characterized by persistent knee pain despite medication and physical therapy
Exclusion Criteria Patients with contraindications to genicular nerve ablation procedures eg allergy to local anesthetics active infection at the procedure site or recent knee surgery within the last six months
Interventions
1 CT-guided Genicular Nerve Ablation Patients will undergo CT-guided genicular nerve ablation involving meticulous planning of needle placement under CT imaging to accurately target the genicular nerves responsible for knee pain Ablation parameters will be standardized to ensure consistency across procedures
2 Fluoroscopic-guided Genicular Nerve Ablation Patients assigned to this group will undergo genicular nerve ablation under fluoroscopic guidance utilizing real-time X-ray imaging to guide needle placement and confirm adequate nerve coverage before ablation
Outcomes
Primary Outcome Reduction in knee pain measured by visual analog scale VAS at 3 months post-procedure
Secondary Outcomes
Improvement in knee function measured by changes in WOMAC scores over the follow-up period
Incidence and nature of any procedure-related adverse events
Patient-reported outcomes regarding satisfaction using the structured PSQ
Follow-Up
Participants will be closely monitored post-procedure with scheduled follow-up visits at 1 week 1 month 3 months and 6 months These visits will include clinical assessments pain evaluations functional tests and documentation of any adverse events
Conclusion
This study aims to provide valuable insights into the comparative effectiveness safety and patient satisfaction of CT-guided versus fluoroscopic-guided genicular nerve ablation in the management of knee osteoarthritis By rigorously evaluating these techniques the findings will inform clinical decision-making optimize treatment strategies and pave the way for future research aimed at enhancing outcomes for patients suffering from chronic knee pain
Knee osteoarthritis is a chronic degenerative joint disease affecting millions worldwide characterized by progressive cartilage loss inflammation and pain Despite various treatment options such as intra-articular corticosteroids viscosupplementation and PRP injections many patients experience inadequate relief or adverse effects Genicular nerve ablation has emerged as a promising minimally invasive technique to alleviate chronic knee pain by interrupting pain transmission from the genicular nerves to the central nervous system
Rationale
The rationale for comparing CT-guided and fluoroscopic-guided genicular nerve ablation lies in optimizing treatment outcomes while ensuring patient safety and satisfaction CT-guided procedures offer unparalleled precision in nerve localization potentially enhancing the accuracy of nerve ablation and improving clinical outcomes However this method involves higher radiation exposure compared to fluoroscopic guidance which utilizes real-time imaging with lower radiation doses Understanding which approach provides superior pain relief functional improvement and patient satisfaction is crucial for optimizing treatment protocols and guiding clinical practice
Objectives
Primary Objective
1 Evaluate the efficacy of CT-guided and fluoroscopic-guided genicular nerve ablation in reducing knee pain as measured by the visual analog scale VAS at 3 months post-procedure
Secondary Objectives
1 Evaluate changes in knee function using the Western Ontario and McMaster Universities Osteoarthritis Index WOMAC a validated scoring system specifically designed for osteoarthritis
2 Monitor and document any procedure-related adverse events to compare the safety profiles of both techniques
3 Evaluate patient satisfaction using the structured Patient Satisfaction Questionnaire PSQ
Study Design
This study is a randomized controlled trial RCT aimed at evaluating the comparative effectiveness of CT-guided versus fluoroscopic-guided genicular nerve ablation Eligible patients will be randomly allocated to one of the two treatment groups Given the specific nature of the interventions it may not be possible to blind participants or operators however to minimize potential bias outcome assessors will be blinded to the treatment assignments
Participants
Inclusion Criteria Adults aged 45-80 diagnosed with knee osteoarthritis refractory to conservative treatment characterized by persistent knee pain despite medication and physical therapy
Exclusion Criteria Patients with contraindications to genicular nerve ablation procedures eg allergy to local anesthetics active infection at the procedure site or recent knee surgery within the last six months
Interventions
1 CT-guided Genicular Nerve Ablation Patients will undergo CT-guided genicular nerve ablation involving meticulous planning of needle placement under CT imaging to accurately target the genicular nerves responsible for knee pain Ablation parameters will be standardized to ensure consistency across procedures
2 Fluoroscopic-guided Genicular Nerve Ablation Patients assigned to this group will undergo genicular nerve ablation under fluoroscopic guidance utilizing real-time X-ray imaging to guide needle placement and confirm adequate nerve coverage before ablation
Outcomes
Primary Outcome Reduction in knee pain measured by visual analog scale VAS at 3 months post-procedure
Secondary Outcomes
Improvement in knee function measured by changes in WOMAC scores over the follow-up period
Incidence and nature of any procedure-related adverse events
Patient-reported outcomes regarding satisfaction using the structured PSQ
Follow-Up
Participants will be closely monitored post-procedure with scheduled follow-up visits at 1 week 1 month 3 months and 6 months These visits will include clinical assessments pain evaluations functional tests and documentation of any adverse events
Conclusion
This study aims to provide valuable insights into the comparative effectiveness safety and patient satisfaction of CT-guided versus fluoroscopic-guided genicular nerve ablation in the management of knee osteoarthritis By rigorously evaluating these techniques the findings will inform clinical decision-making optimize treatment strategies and pave the way for future research aimed at enhancing outcomes for patients suffering from chronic knee pain
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