Clinical trial NCT06514703: Comparative Study of CT and Fluoroscopic Guided Genicular Nerve Ablation in the Treatment of Knee Osteoarthritis
Official title: Comparative Study of CT and Fluoroscopic Guided Genicular Nerve Ablation in the Treatment of Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Knee Osteoarthritis
Genicular Nerve Ablation
CT-guided Ablation
Fluoroscopic-guided Ablation
Pain Management
Minimally Invasive Procedures
Patient Satisfaction
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2024-07-23
Enrollment: 60
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 (e.g., 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.

Eligibility criteria: Inclusion Criteria:

* Adults aged 45 to 80 years.
* Diagnosed with knee osteoarthritis.
* Knee osteoarthritis refractory to conservative treatment.
* Able to provide informed consent.
* Agree to follow the study procedures and attend follow-up visits.

Exclusion Criteria:

* Prior knee surgery within the last six months.
* Contraindications to genicular nerve ablation (e.g., certain types of infections, bleeding disorders).
* Severe comorbid conditions that may interfere with the study outcomes (e.g., rheumatoid arthritis, other severe autoimmune diseases).
* Current participation in another clinical trial that could interfere with the outcomes of this study.
* Allergy or sensitivity to the materials used in the ablation procedures.

Primary outcomes:
measure: Reduction in Knee Pain
timeFrame: 3 months post-procedure
Secondary outcomes:
measure: Improvement in Knee Function
timeFrame: Assessed at baseline, 1 month, 3 months, and 6 months post-procedure
measure: Incidence of Procedure-Related Adverse Events
timeFrame: From the time of procedure up to 6 months
measure: Patient Satisfaction with the Procedure
timeFrame: 3 months post-procedure
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University, Faculty of Medicine
state: Sharkia
Study officials:
affiliation: Assistant Professor of Diagnostic and Interventional Radiology, Zagazig Uni.
name: Ahmed A Bessar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: