Preop Cooled Radiofrequency Ablation for Total Knee Replacement

A Pilot Study on the Utility of Cooled Radiofrequency Ablation in Patients Prior to Total Knee Arthroplasty

Total knee replacement surgery is commonly performed for patients suffering from severe knee osteoarthritis. However, 20% of patients continue to experience pain after surgery. There is currently no standardized pain management protocol for pain after total knee replacement. Cooled radiofrequency ablation has been used successfully to alleviate spin-related pain and has recently been approved by the FDA to treat chronic knee arthritic pain. This pilot study aims to collect preliminary data on the use of cooled radiofrequency ablation in patients undergoing total knee replacement.

Study Overview

• Status: Withdrawn
• Conditions: Postoperative Pain; Knee Osteoarthritis
• Intervention / Treatment: Procedure: Total knee replacement; Device: COOLIEF

Detailed Description

The number of patients who undergo total knee replacement is rising significantly. However, many of these patients are dissatisfied with the results, because they continue to experience pain postoperatively. This pain can be debilitating and can also be associated with decreased quality of life. Given the increasing number of patients undergoing total knee replacement and a dissatisfaction rate of 8-44%, improvements must be made in pain management protocols to help decrease pain in the immediate postoperative period following total knee replacement. Cooled radiofrequency ablation is a procedure that uses water-cooled technology to denervate the sensory nerves. It is widely used in the spine and is increasingly being used in the knee to treat osteoarthritis. Existing studies have shown that it can significantly reduce pain in patients with chronic osteoarthritis. In terms of its potential benefit as a preoperative measure to minimize postoperative pain, the literature is sparse. Results from this study will be used to generate hypotheses and power for future studies.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Hospital for Special Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing unilateral primary total knee replacement for the treatment of knee osteoarthritis

Description

Inclusion Criteria:

• Patients undergoing unilateral primary total knee replacement for osteoarthritis
• Pain >6 (on a scale of 0-10)
• Body mass index: 21-35 kg/m2

Exclusion Criteria:

• Age <65 years
• Patients who are wheelchair bound
• History of inflammatory arthritis or rheumatic disease
• Body mass index <21 or >35 kg/m2
• Chronic opioid use
• Pregnant women
• Non-English speaking

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Preoperative cooled radiofrequency ablation; Patients who undergo cooled radiofrequency ablation within 4-8 weeks of their scheduled total knee replacement.	Procedure: Total knee replacement; Patients will undergo total knee replacement surgery.; Device: COOLIEF; The superior lateral genicular nerve, superior medial genicular nerve, and inferior medial geniculate nerve will be ablated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	Pain will be assessing on a 0-10 scale, where 0=no pain and 10=most pain.	Up to 1 year post-total knee replacement

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee Disability	Knee disability will be assessed using the Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR). The score ranges from 0-100, where 0=total knee disability and 10=perfect health.	Up to 1 year post-total knee replacement
Function assessed using the PROMIS-physical function computer adaptive test	Function will be assessed using the PROMIS-physical function computer adaptive test. A higher score indicates higher function.	Up to 1 year post-total knee replacement

Collaborators and Investigators

• Sponsor: Hospital for Special Surgery, New York
• Investigators: Principal Investigator: Jonathan Kirschner, MD, Hospital for Special Surgery, New York

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2019
• Primary Completion (Actual): October 30, 2020
• Study Completion (Actual): October 30, 2020

Study Registration Dates

• First Submitted: March 26, 2019
• First Submitted That Met QC Criteria: March 27, 2019
• First Posted (Actual): March 28, 2019

Study Record Updates

• Last Update Posted (Actual): November 13, 2020
• Last Update Submitted That Met QC Criteria: November 10, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 2018-1149

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes