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Does Radiofrequency Ablation of the Articular Nerves of the Knee Prior to Total Knee Replacement Improve Pain Outcomes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02746874
Recruitment Status : Active, not recruiting
First Posted : April 21, 2016
Last Update Posted : September 6, 2018
Sponsor:
Collaborator:
Halyard Health
Information provided by (Responsible Party):
David Walega, Northwestern University

Brief Summary:

More than 300,000 total knee joint replacement surgeries are performed per year in the United States and safe, effective management of post-operative pain in these patients, often elderly, deconditioned, obese, or with co-morbid diseases like sleep apnea, can be challenging and often require a multidisciplinary, multimodal approach. Opiates have been a mainstay of treatment in the post-operative period with varying degrees of success and complications. Inadequately controlled postoperative pain is not uncommon. Poorly controlled pain inhibits early mobilization and hinders post-operative physical therapy.

A new paradigm for treating post-operative pain following total knee replacement may be the use of cooled radiofrequency ablation (C-RFA) of the articular sensory nerve supply of the knee capsule prior to surgery, to desensitize the knee by blocking sensory afferents to the anterior capsule and thereby decrease post-operative pain. There are several publications that have demonstrated the use of RFA in patients with chronic knee pain from osteoarthritis however the use of RFA in the preoperative management of pain in patients undergoing total knee joint replacement has not been investigated.

The aim of this study is to determine if patients undergoing unilateral total knee replacement obtain any post-operative pain relieving benefits from C-RFA of the articular sensory nerve supply when performed prior to surgery, as compared to sham controls who receive only local anesthetic injections of these same nerves without the benefit of ablation treatment.


Condition or disease Intervention/treatment Phase
Arthroplasty, Replacement, Knee Procedure: Radiofrequency Ablation (RFA) Procedure: Simulated Radiofrequency Ablation (RFA) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Radiofrequency Ablation of the Articular Nerves of the Knee Prior to Total Knee Replacement Improve Pain Outcomes? A Prospective Randomized Sham-Control Trial With 6 Month Follow Up
Study Start Date : December 2015
Estimated Primary Completion Date : November 15, 2018
Estimated Study Completion Date : November 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Active Comparator: Active Group
Radiofrequency ablation procedure of the three articular branches of the knee joint. The targets will be thermally lesioned for 2 minutes 30 seconds thereby causing neurolysis.
Procedure: Radiofrequency Ablation (RFA)
The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected prior to lesioning.

Sham Comparator: Placebo Group
Simulated Radiofrequency Ablation procedure of the three articular branches of the knee joint.The targets will be not be thermally lesioned for 2 minutes 30 seconds therefore not causing neurolysis.
Procedure: Simulated Radiofrequency Ablation (RFA)
The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected. A simulate sham lesion will be performed at each target site.




Primary Outcome Measures :
  1. Opioid consumption after surgery [ Time Frame: 48 hours ]
    Pain medication will be calculated into morphine equivalents


Secondary Outcome Measures :
  1. Pain Score [ Time Frame: Baseline, Day of Surgery, 48 hours after surgery, and 1 (+/-1), 3 (+/-1), and 6 (+/-1) months following surgery ]
    Numerical rating pain score (0 to 10, where 0 is no pain and 10 is unbearable pain).



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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • osteoarthritis of the knee scheduled to undergo their first unilateral knee joint replacement
  • willingness to undergo fluoroscopy-guided C-RFA or sham treatment

Exclusion Criteria:

  • pregnancy,
  • severe cardiac/pulmonary compromise,
  • acute illness/infection,
  • coagulopathy
  • bleeding disorder,
  • allergic reactions,
  • contraindications to a local anesthetic

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): NCT02746874


Locations
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United States, Illinois
Anesthesiology Pain Medicine Center
Chicago, Illinois, United States, 60605
Sponsors and Collaborators
Northwestern University
Halyard Health
Investigators
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Principal Investigator: David Walega, MD Northwestern University Feinberg School of Medicine
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: David Walega, Associate Professor of Anesthesiology, Northwestern University
ClinicalTrials.gov Identifier: NCT02746874    
Other Study ID Numbers: STU00200439
First Posted: April 21, 2016    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by David Walega, Northwestern University:
Total Knee Replacement, Replacement of the knee joint,