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

November 17, 2017 updated by: Andrés Camprodón Alberca, Hospital Son Espases

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Observational

Enrollment (Actual)

40

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The procedure was performed to 33 patients with OA (two of them with inflammatory causes) and in 7 patients with TKA (four with revised TKA).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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".
one year after the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
one year after the procedure
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).
one year after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Son Espases

Collaborators

José Andrés López Riquelme
María del Pilar Sanchís Cortés

Investigators

  • Principal Investigator: Andrés Camprodón Alberca, Hospital Son Espases

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2015

Primary Completion (Actual)

May 26, 2016

Study Completion (Actual)

May 26, 2017

Study Registration Dates

First Submitted

November 13, 2017

First Submitted That Met QC Criteria

November 13, 2017

First Posted (Actual)

November 17, 2017

Study Record Updates

Last Update Posted (Actual)

November 20, 2017

Last Update Submitted That Met QC Criteria

November 17, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Osteoarthritis, Knee

Clinical Trials on cooled radiofrequency ablation of genicular nerves

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uganda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe