Sequential Genicular Nerve Ablation Prior to Geniculate Artery Embolization in Knee Pain

NCT06514755 | Recruiting

• 1 other identifier: GNA-GAE-KP
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate whether performing genicular nerve ablation (GNA) before geniculate artery embolization (GAE) improves pain relief and knee function in patients with chronic knee pain. The main questions it aims to answer are:

• Does performing GNA prior to GAE enhance pain relief, as measured by the Visual Analog Scale (VAS), at 3 months post-procedure?
• Does the sequential approach improve knee function as assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)? Study investigators will compare two groups to see if the sequential approach (GNA followed by GAE) provides better outcomes compared to GAE alone. Participants will:
• Undergo either sequential GNA followed by GAE or GAE alone
• Have their knee pain and function assessed at baseline, 1 month, 3 months, and 6 months post-procedure
• Complete a structured patient satisfaction questionnaire (PSQ) at 3 months post-procedure
• Be monitored for procedure-related adverse events up to 6 months post-procedure,

Conditions

Chronic Knee Pain; Osteoarthritis

Keywords

Genicular Nerve Ablation; Geniculate Artery Embolization; Knee Function; Patient Satisfaction

Outcome Measures

Primary Outcomes (1)

• Reduction in Knee Pain

  This outcome measures 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 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)

Sequential GNA Followed by GAE

EXPERIMENTAL

Participants in this group will undergo genicular nerve ablation (GNA), followed by geniculate artery embolization (GAE) one month later. The GNA procedure will target the genicular nerves responsible for knee pain, and the GAE procedure will target the geniculate arteries to reduce inflammation and pain. The sequence is designed to optimize pain relief and functional outcomes.

Procedure: GNA followed by GAE

GAE Alone

ACTIVE COMPARATOR

Participants in this group will receive geniculate artery embolization (GAE) alone, without prior genicular nerve ablation (GNA). The GAE procedure will target the geniculate arteries to reduce inflammation and pain. This arm serves as the control to compare the effectiveness and safety of the sequential GNA followed by GAE intervention.

Procedure: GAE alone

Interventions

GNA followed by GAE PROCEDURE

Participants in the experimental arm will undergo genicular nerve ablation (GNA), a minimally invasive procedure targeting the genicular nerves to interrupt pain transmission. One month after undergoing GNA, participants will receive geniculate artery embolization (GAE), which targets the geniculate arteries to reduce inflammation and pain.

Sequential GNA Followed by GAE

GAE alone PROCEDURE

Participants in the active comparator arm will receive geniculate artery embolization (GAE) alone, a minimally invasive procedure targeting the geniculate arteries to reduce inflammation and pain, without prior genicular nerve ablation (GNA).

GAE Alone

Eligibility Criteria

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

You may qualify if:

• Adults aged 18 to 80 years.
• Diagnosed with chronic knee pain 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:

• Contraindications to GNA or GAE procedures (e.g., allergy to local anesthetics, active infection at the procedure site).
• Recent knee surgery within the last six months.
• 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University, Faculty of Medicine

Zagazig, 44519, Egypt

RECRUITING

MeSH Terms

Conditions

Osteoarthritis; Patient Satisfaction

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; 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: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Diagnostic and Interventional Radiology

Model Details: Participants will be randomly assigned to one of two groups: one undergoing sequential genicular nerve ablation (GNA) followed by geniculate artery embolization (GAE), and the other receiving GAE alone.

Study Record Dates

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

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)