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Knee Genicular Nerve Ablation by Thermal Radiofrequency vs Thermal Radiofrequency Plus Alcohol Neurolysis

A

Ain Shams University

Status

Enrolling

Conditions

Knee Osteoarthritis

Treatments

Procedure: genicular nerve ablation by thermal radiofrequency
Procedure: genicular nerve ablation by thermal radiofrequency plus alcohol neurolysis

Study type

Interventional

Funder types

Other

Identifiers

NCT05980338
knee genicular nerve ablation

Details and patient eligibility

About

the aim of our study is to compare effectiveness (satisfaction) and duration of pain relief between patients receiving the conventional thermal radiofrequency on the genicular nerves alone vs patients who will receive the conventional method plus alcohol neurolysis of the targeted nerves.

Enrollment

52 estimated patients

Sex

All

Ages

60 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Both genders.
  2. Age between 60-70 years.
  3. ASA 1,2 & 3 physical status.
  4. x ray imaging confirming the osteoarthritis and unwell or not candidate for knee replacement surgery

Exclusion criteria

  1. Neurological disorders.(previous cerebrovascular stroke , neuropathy , or weakness )
  2. coagulopathy ( plt < 50000, INR > 1.7 )
  3. Infection at or near the injection site.
  4. presence of pacemaker or defibrillator 5 - Acute knee injury.

6- age < 60 or >70 years

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

52 participants in 2 patient groups

control group
Active Comparator group
Description:
The patients are placed in supine position with knee preparation using an iodine-based product and drape in a sterile manner Then the ground pad of the radio frequency machine will be placed in the other leg (we used the Neurotherm NT1100 re generator) All the patients will be monitored by ECG, noninvasive blood pressure and pulse oximetry The 3 entry sites will be detected under fluoroscopy then local anesthesia will be performed using lidocaine 2% followed by the insertion of the 3 radiofrequency cannulas (STRYKER 20 G, 9 cm with 1 cm active tip) targeting the 3 main nerves ( superior medial genicular, superior lateral genicular and the inferior medial genicular nerves ). this group will receive radio frequency alone .
Treatment:
Procedure: genicular nerve ablation by thermal radiofrequency
study group
Experimental group
Description:
this group will pass through the all steps but after the radiofrequency is done at each level a 1 ml of 70% alcohol will be injected making a total of 3 ml injection to each nerve.
Treatment:
Procedure: genicular nerve ablation by thermal radiofrequency
Procedure: genicular nerve ablation by thermal radiofrequency plus alcohol neurolysis

Trial contacts and locations

1

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Central trial contact

samuel H Daniel, MD; Lydia E Zakhary, MD

Data sourced from clinicaltrials.gov

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