Comparative Study of CT and Fluoroscopic Guided Genicular Nerve Ablation in the Treatment of Knee Osteoarthritis

NCT06514703 | Recruiting

• 1 other identifier: CTFGNA-KOA
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Keywords

Knee Osteoarthritis; Genicular Nerve Ablation; CT-guided Ablation; Fluoroscopic-guided Ablation; Pain Management; Minimally Invasive Procedures; Patient Satisfaction

Outcome Measures

Primary Outcomes (1)

• Reduction in Knee Pain

  This measure assesses the change in knee pain as reported by participants using the Visual Analog Scale (VAS). A lower score indicates less pain, signifying an improvement.

  3 months post-procedure

Secondary Outcomes (3)

• Improvement in Knee Function

  Assessed at baseline, 1 month, 3 months, and 6 months post-procedure

• Incidence of Procedure-Related Adverse Events

  From the time of procedure up to 6 months

• Patient Satisfaction with the Procedure

  3 months post-procedure

Study Arms (2)

CT-Guided Genicular Nerve Ablation

EXPERIMENTAL

Participants in this arm will undergo genicular nerve ablation using computed tomography (CT) guidance. The procedure involves precise needle placement based on CT imaging to effectively target the genicular nerves responsible for transmitting pain signals from the knee.

Procedure: CT-Guided Genicular Nerve Ablation

Fluoroscopic-Guided Genicular Nerve Ablation

ACTIVE COMPARATOR

Participants in this arm will receive genicular nerve ablation using fluoroscopic guidance. The procedure utilizes real-time fluoroscopy to guide needle placement for the ablation of the genicular nerves.

Procedure: Fluoroscopic-Guided Genicular Nerve Ablation

Interventions

CT-Guided Genicular Nerve Ablation PROCEDURE

This procedure involves using computed tomography (CT) imaging to guide the precise placement of a needle for the ablation of genicular nerves in the knee. The goal is to disrupt the pain signals caused by osteoarthritis, providing long-term pain relief. The intervention is performed under local anesthesia and is aimed at patients who have not responded adequately to conservative pain management strategies.

CT-Guided Genicular Nerve Ablation

Fluoroscopic-Guided Genicular Nerve Ablation PROCEDURE

This procedure utilizes fluoroscopy to accurately guide the needle placement for the ablation of genicular nerves associated with osteoarthritis knee pain. The technique focuses on minimizing pain and improving functional mobility by disrupting nerve pathways that transmit pain signals. Like the CT-guided approach, it is intended for use in patients whose symptoms have not been sufficiently managed with non-invasive treatments.

Fluoroscopic-Guided Genicular Nerve Ablation

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University, Faculty of Medicine

Zagazig, Sharqia Province, 44519, Egypt

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee; Agnosia; Patient Satisfaction

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Ahmed A Bessar, MD, PhD

  Assistant Professor of Diagnostic and Interventional Radiology, Zagazig Uni.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed A Bessar, MD, PhD

CONTACT

+201000089595; Ahmedawadbessar@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: In this randomized controlled trial, a partial blinding strategy is employed where only the outcomes assessors are blinded to intervention group assignments. Given the distinct nature of the CT-guided and fluoroscopic-guided procedures, it is impractical to blind participants and care providers. Operators performing the ablation and participants will be aware of the imaging technique used. However, to ensure unbiased evaluation of clinical outcomes, outcomes assessors will not know participants' group assignments. This measure is crucial for preventing observer bias in assessing primary and secondary outcomes such as pain relief, functional improvement, and patient satisfaction.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Diagnostic and Interventional Radiology

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: July 23, 2024
• Study Start: September 29, 2024
• Primary Completion: April 30, 2025
• Study Completion: May 30, 2025
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)