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

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ClinicalTrials.gov Identifier: NCT02746874
Recruitment Status : Completed
First Posted : April 21, 2016
Results First Posted : February 2, 2021
Last Update Posted : February 2, 2021
Sponsor:
Information provided by (Responsible Party):
David Walega, Northwestern University

Tracking Information
First Submitted Date  ICMJE April 18, 2016
First Posted Date  ICMJE April 21, 2016
Results First Submitted Date  ICMJE August 20, 2019
Results First Posted Date  ICMJE February 2, 2021
Last Update Posted Date February 2, 2021
Actual Study Start Date  ICMJE December 1, 2016
Actual Primary Completion Date June 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 12, 2021)
Opioid Consumption After Surgery [ Time Frame: 48 hours ]
Pain medication will be calculated into oral morphine equivalents (ME) for the first 48 hours after surgery. Morphine equivalents determine a patient's cumulative intake of any drugs in the opioid class.
Original Primary Outcome Measures  ICMJE
 (submitted: April 18, 2016)
Opioid consumption after surgery [ Time Frame: 48 hours ]
Pain medication will be calculated into morphine equivalents
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2021)
  • Oral Morphine Equivalent Milligrams at Baseline. [ Time Frame: Pre operative ]
    The total morphine equivalent (milligrams) reported by the subject at baseline.
  • Oral Morphine Equivalents at Baseline Compared to 48 Hours Post-operative. [ Time Frame: 48 hours ]
    Total oral morphine equivalents at baseline compared to oral morphine equivalents at 48 hours post-operative.
  • Medication Quantification Scale III (MQSIII) Score 48 Hours Post-operative. [ Time Frame: 48 hours ]
    Medication Quantification Scale III (MQSIII) is a method of quantifying different pain drug regimens by evaluating the use of 22 distinct drug classes (e.g., nonsteroidal anti-inflammatory drugs [NSAIDs], antidepressants, benzodiazepines, opiates). A single value is calculated based on a patient's pain medication profile, taking into account dosages, and the types of pain medications prescribed. The score is calculated for a given pharmacologic class by taking its detriment weight, as determined by the physician, multiplied by a score given for dosage. The scores for each pharmacologic class prescribed to a patient are then summed to determine the overall score of a given pain medication regimen. The scale ranges from (0 low (good) 500 high (poor).
  • Number of Stairs Climbed on Post-operative Day 2. [ Time Frame: Post operative day 2 ]
    Number of stairs climbed on post-operative day 2 prior to discharge from the hospital.
  • Distance Walked on Post-operative Day 2. [ Time Frame: Post operative day 2 ]
    Distance in feet walked on post-operative day 2 prior to discharge from the hospital.
  • Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score 6 Months Post Operative [ Time Frame: 6 months post operative ]
    Western Ontario and McMaster Universities Arthritis Index (WOMAC) score 6 months post operative. The WOMAC score is a survey comprised of 24 items divided into three subscales: Pain (5 items), stiffness (2 items), and physical function (17 items). Subjects are asked a range of questions about their ability to carry out daily activities such as using the stairs, rising from sitting, lying in bed and conducting light or heavy domestic duties. Items are scored on a scale of 0-4 (lower scores indicate lower levels of symptoms or physical disability). Values are summed up for a combined WOMAC score of 0 (low) to 96 (high) Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitation.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2016)
Pain Score [ Time Frame: Baseline, Day of Surgery, 48 hours after surgery, and 1, 3, and 6 months following surgery ]
NRS pain scores (0 to 10, where 0 is no pain and 10 is unbearable pain).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Does Radiofrequency Ablation of the Articular Nerves of the Knee Prior to Total Knee Replacement Improve Pain Outcomes
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Arthroplasty, Replacement, Knee
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: Radiofrequency Ablation (RFA)
  • 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.
    Intervention: Procedure: Simulated Radiofrequency Ablation (RFA)
Publications * Walega D, McCormick Z, Manning D, Avram M. Radiofrequency ablation of genicular nerves prior to total knee replacement has no effect on postoperative pain outcomes: a prospective randomized sham-controlled trial with 6-month follow-up. Reg Anesth Pain Med. 2019 Apr 25. pii: rapm-2018-100094. doi: 10.1136/rapm-2018-100094. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 19, 2017)
70
Original Estimated Enrollment  ICMJE
 (submitted: April 18, 2016)
60
Actual Study Completion Date  ICMJE December 31, 2017
Actual Primary Completion Date June 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02746874
Other Study ID Numbers  ICMJE STU00200439
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party David Walega, Northwestern University
Study Sponsor  ICMJE Northwestern University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David Walega, MD Northwestern University Feinberg School of Medicine
PRS Account Northwestern University
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP