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

M

Mansoura University

Status

Unknown

Conditions

Chronic Knee Osteoarthritis

Treatments

Procedure: Bipolar radiofrequency ablation
Procedure: Monopolar radiofrequency ablation

Study type

Interventional

Funder types

Other

Identifiers

NCT04112264
MD.19.03.152

Details and patient eligibility

About

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.

Full description

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

Enrollment

50 estimated patients

Sex

All

Ages

40 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

50 participants in 2 patient groups

Monopolar radiofrequency ablation
Experimental group
Description:
Patients will receive ultrasound-guided monopolar radiofrequency ablation
Treatment:
Procedure: Monopolar radiofrequency ablation
Bipolar radiofrequency ablation
Active Comparator group
Description:
Patients will receive ultrasound-guided bipolar radiofrequency ablation
Treatment:
Procedure: Bipolar radiofrequency ablation

Trial contacts and locations

1

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Central trial contact

Sherif A Mousa, MD; Ola T Abd El-Dayem, MD

Data sourced from clinicaltrials.gov

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