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

NCT03343808 | Completed FDA Device

• 1 other identifier: 1-2017
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Osteoarthritis, Knee

Keywords

Cooled radiofrequency; chronic knee pain; knee arthroplasty; genicular nerve

Outcome Measures

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).

  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 Outcomes (2)

• Short Form (36) Health Survey

  one year after the procedure

• Knee Society Score (KSS)

  one year after the procedure

Interventions

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.

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Son Espases: lead
• José Andrés López Riquelme: collaborator
• María del Pilar Sanchís Cortés: collaborator

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Andrés Camprodón Alberca

  Hospital Son Espases

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedic Surgeon

Study Record Dates

• First Submitted: November 13, 2017
• First Posted: November 17, 2017
• Study Start: January 8, 2015
• Primary Completion: May 26, 2016
• Study Completion: May 26, 2017
• Last Updated: November 20, 2017

Record last verified: 2017-11