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Completed

NCT Number: NCT03343808

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

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

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Observational

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cooled radiofrequency ablation of genicular nerves

Procedure

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.

Primary outcomes

  1. Treatment success was defined as the number of subjects whose knee pain is reduced by ± 50% based on the Visual Analogue Scale (VAS).

    Time frame: one year after the procedure

    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".

Secondary outcomes

  1. Short Form (36) Health Survey

    Time frame: one year after the procedure

    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.

  2. Knee Society Score (KSS)

    Time frame: one year after the procedure

    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).

Sponsors and collaborators

Lead sponsor

Hospital Son Espases

Other

Collaborators

  • José Andrés López Riquelme
  • María del Pilar Sanchís Cortés

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Nov 17, 2017
Registry last updated
Nov 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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