Retrospective Study of the Results of Cooled Radiofrequency for Genicular Nerves Neurotomy in 40 Consecutive Patients With Osteoarthritis of the Knee and Painful Knee Arthroplasty

Osteoarthritis, Knee Clinical Trial

Official title:

Pain Treatment With Cooled Radiofrequency in Osteoarthritis and Total Knee Arthroplasty: Case Series in Hospital Universitario de Son Espases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03343808
• Other study ID #: 1-2017
• Status: Completed
• Phase: N/A
• First received: November 13, 2017
• Last updated: November 17, 2017
• Start date: January 8, 2015
• Est. completion date: May 26, 2017

Study information

• Verified date: November 2017
• Source: Hospital Son Espases
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Analyze the results of cooled radiofrequency in patients with chronic knee pain after one year of follow- up.

Description:

The investigators performed a retrospective case-series reviewed of 40 patients who underwent cooled RF of genicular nerves. The investigators evaluated results of the survey of quality of life (SF36), knee society score (KSS) and the Visual Analogue Scale (VAS).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 26, 2017
• Est. primary completion date: May 26, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

Inclusion Criteria:

• Chronic knee pain (older than 3 months, with no response to physiotherapy, medication or hyaluronic acid infiltration) with a pain intensity according to VAS>7/10

• The radiological criteria were witness of OA with Kellgren-Lawrence index of 2 to 4.

• Painful TKA with no apparent cause and with a radiological image where a proper placement was observed

Exclusion Criteria:

• Infection or lymphangitis of the member

• Acute knee pain

• Corticoids or hyaluronic acid infiltration with a high molecular weight prior to the surgery

• Pregnancy

• Severe neurological or psychiatric disorders

• Patients with pacemakers

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• cooled radiofrequency ablation of genicular nerves
Cooled RF consists of creating an injury in the nerve trough a high frequency flow. Unlike conventional RF, in cooled RF through a closed circuit where intravenous flows, we can create an injury for a longer period of time, at a lower temperature (standard RFA 90º C, cooled RFA 60º C) and within an area 8 times larger. As the lesion is spherical, and larger (about 10-12 mm in diameter), the chances of neurolysis of the nerve increase.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Hospital Son Espases	José Andrés López Riquelme, María del Pilar Sanchís Cortés

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment success was defined as the number of subjects whose knee pain is reduced by ± 50% based on the Visual Analogue Scale (VAS).	The VAS is a 11- point scale (0 points to 10 points), where 0 points equals "no pain" and 10 points equals the "worst pain".	one year after the procedure
Secondary	Short Form (36) Health Survey	The SF36 values eight parameters: physical function, social function, physical role, emotional role, mental health, vitality, pain and general health. Zero is the worst conceivable health and 100 the best.	one year after the procedure
Secondary	Knee Society Score (KSS)	The KSS consists of two parts. KS measures pain, range of motion, stability and alignment. FS measures the distance able to walk, the difficulty in going up or down stairs and the need for walking aids. The result is rated as excellent (80-100), good (70-79), regular (60-69) and bad (<60).	one year after the procedure