Ultrasound-guided Monopolar Versus Bipolar Radiofrequency Ablation for Genicular Nerves in Chronic Knee Osteoarthritis

NCT ID: NCT04112264

Last Updated: 2020-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-04

Study Completion Date

2021-06-01

Brief Summary

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Radiofrequency ablation of the genicular nerves using ultrasound is safe and effective for treating intractable knee osteoarthritis pain by using either monopolar or bipolar radiofrequency ablation.

This technique is based on anatomical studies demonstrating that genicular nerves are accompanied by genicular arteries. Ultrasound-guided RF genicular ablation yielded both significant reductions in knee pain and improvements in functional capacity.

Detailed Description

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The aim of this study is to compare between ultrasound guided monopolar and bipolar radiofrequency ablation in chronic knee osteoarthritis.

Osteoarthritis of knee joint is one of the most common disease conditions with advanced age and leads to considerable morbidity in terms of pain, stiffness, limitation in functions, disturbance in sleep and psychological disturbance

A diagnostic genicular nerve block (GNB) with local anesthetic is performed before RF genicular ablation, and a successful response to GNB is considered to indicate the need for RF genicular ablation

Conditions

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Chronic Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Monopolar radiofrequency ablation

Patients will receive ultrasound-guided monopolar radiofrequency ablation

Group Type EXPERIMENTAL

Monopolar radiofrequency ablation

Intervention Type PROCEDURE

a radiofrequency cannula is advanced under USG guidance towards the nerve. The final position will be confirmed by using nerve stimulator with elicitation of paraesthesia along the area of knee joint supplied by that respected genicular nerve by stimulation at 50 Hz current of \<0.5 mV. The motor stimulation will be negative at all instances. For each genicular nerve, two conventional RF lesions are done for 120s at 80° of temperature using the Neurotherm 1100 RF generator.

Bipolar radiofrequency ablation

Patients will receive ultrasound-guided bipolar radiofrequency ablation

Group Type ACTIVE_COMPARATOR

Bipolar radiofrequency ablation

Intervention Type PROCEDURE

Two radiofrequency cannula are advanced under USG guidance towards the nerve. The final position will be confirmed by using nerve stimulator with elicitation of paraesthesia by stimulation at 50 Hz current of \<0.5 mV. The motor stimulation will be negative at all instances. For each genicular nerve, two conventional RF lesions are done for 120s at 80° of temperature using the Neurotherm 1100 RF generator.

Interventions

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Monopolar radiofrequency ablation

a radiofrequency cannula is advanced under USG guidance towards the nerve. The final position will be confirmed by using nerve stimulator with elicitation of paraesthesia along the area of knee joint supplied by that respected genicular nerve by stimulation at 50 Hz current of \<0.5 mV. The motor stimulation will be negative at all instances. For each genicular nerve, two conventional RF lesions are done for 120s at 80° of temperature using the Neurotherm 1100 RF generator.

Intervention Type PROCEDURE

Bipolar radiofrequency ablation

Two radiofrequency cannula are advanced under USG guidance towards the nerve. The final position will be confirmed by using nerve stimulator with elicitation of paraesthesia by stimulation at 50 Hz current of \<0.5 mV. The motor stimulation will be negative at all instances. For each genicular nerve, two conventional RF lesions are done for 120s at 80° of temperature using the Neurotherm 1100 RF generator.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Radiologic tibiofemoral Osteoarthritis (Kellgren-Lawrence grade 2-4).
* Patients not responding to other treatments as physiotherapy, oral analgesics, and intraarticular injection with hyaluronic acids or steroids.
* Patients refused surgery.

Exclusion Criteria

* Patient refusal.
* Prior knee surgery.
* Acute knee pain.
* Intra-articular knee corticosteroid or hyaluronic acid injection in the past 3 months.
* Connective tissue diseases that affected the knee.
* Anticoagulant medication use.
* Local skin infection and sepsis at the site of intervention
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sherif A Mousa, MD

Role: STUDY_CHAIR

Professor of Anesthesia and Surgical Intensive Care

Locations

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Mansoura University

Al Mansurah, DK, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Sherif A Mousa, MD

Role: CONTACT

00201001637298

Ola T Abd El-Dayem, MD

Role: CONTACT

00201202811110

Facility Contacts

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Sherif A Mousa, MD

Role: primary

00201001637298

Ola T Abd El-Dayem, MD

Role: backup

00201202811110

Other Identifiers

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MD.19.03.152

Identifier Type: -

Identifier Source: org_study_id

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