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Preop Cooled Radiofrequency Ablation for Total Knee Replacement

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ClinicalTrials.gov Identifier: NCT03893292
Recruitment Status : Withdrawn (Lack of participants)
First Posted : March 28, 2019
Last Update Posted : November 13, 2020
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Postoperative Pain Knee Osteoarthritis 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 Design
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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Pilot Study on the Utility of Cooled Radiofrequency Ablation in Patients Prior to Total Knee Arthroplasty
Actual Study Start Date : January 24, 2019
Actual Primary Completion Date : October 30, 2020
Actual Study Completion Date : October 30, 2020

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Groups and Cohorts
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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.


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


Secondary Outcome Measures :
  1. Knee Disability [ Time Frame: Up to 1 year post-total knee replacement ]
    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.

  2. Function assessed using the PROMIS-physical function computer adaptive test [ Time Frame: Up to 1 year post-total knee replacement ]
    Function will be assessed using the PROMIS-physical function computer adaptive test. A higher score indicates higher function.


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing unilateral primary total knee replacement for the treatment of knee osteoarthritis
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03893292


Locations
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United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
Sponsors and Collaborators
Hospital for Special Surgery, New York
Investigators
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Principal Investigator: Jonathan Kirschner, MD Hospital for Special Surgery, New York
More Information
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Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT03893292    
Other Study ID Numbers: 2018-1149
First Posted: March 28, 2019    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases