Clinical trial NCT04112264: Ultrasound-guided Monopolar Versus Bipolar Radiofrequency Ablation for Genicular Nerves in Chronic Knee Osteoarthritis
Official title: Effect of Monopolar Radiofrequency Ablation for Genicular Nerves Compared to Bipolar Radiofrequency Ablation Using Ultrasound in Treating Chronic Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Knee Osteoarthritis
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2019-10-02
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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

Eligibility criteria: 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

Primary outcomes:
measure: Osteoarthritis pain
timeFrame: basal value, at 1, 4, 12, 24 weeks post procedure
Secondary outcomes:
measure: Oxford Knee Score
timeFrame: basal value, at 1, 4, 12, 24 weeks post procedure
measure: The procedure time
timeFrame: from the start of advancement of the cannula to end of procedure.
measure: Patient satisfaction score
timeFrame: up to 24 weeks post procedure
measure: Changes in doses of rescue analgesics
timeFrame: up to 24 weeks post procedure
measure: The incidence of numbness
timeFrame: up to 24 weeks post procedure
measure: The incidence of paresthesia
timeFrame: up to 24 weeks post procedure
measure: The incidence of motor weakness
timeFrame: up to 24 weeks post procedure
measure: the proportion of successful responders
timeFrame: up to 24 weeks post procedure
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Mansoura University
state: DK
Study officials:
affiliation: Professor of Anesthesia and Surgical Intensive Care
name: Sherif A Mousa, MD
role: STUDY_CHAIR
References: