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Preop Cooled Radiofrequency Ablation for Total Knee Replacement

NCT ID: NCT03893292

Last Updated: 2020-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-24

Study Completion Date

2020-10-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Postoperative Pain Knee Osteoarthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Preoperative cooled radiofrequency ablation

Patients who undergo cooled radiofrequency ablation within 4-8 weeks of their scheduled total knee replacement.

Total knee replacement

Intervention Type PROCEDURE

Patients will undergo total knee replacement surgery.

COOLIEF

Intervention Type DEVICE

The superior lateral genicular nerve, superior medial genicular nerve, and inferior medial geniculate nerve will be ablated.

Interventions

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Total knee replacement

Patients will undergo total knee replacement surgery.

Intervention Type PROCEDURE

COOLIEF

The superior lateral genicular nerve, superior medial genicular nerve, and inferior medial geniculate nerve will be ablated.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital for Special Surgery, New York

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jonathan Kirschner, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital for Special Surgery, New York

Locations

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Hospital for Special Surgery

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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2018-1149

Identifier Type: -

Identifier Source: org_study_id