Trial Outcomes & Findings for Does Radiofrequency Ablation of the Articular Nerves of the Knee Prior to Total Knee Replacement Improve Pain Outcomes (NCT NCT02746874)

NCT ID: NCT02746874

Last Updated: 2021-02-02

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 70 participants
• Primary outcome timeframe: 48 hours
• Results posted on: 2021-02-02

Participant Flow

Participant milestones

Measure	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. 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.	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. 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.
Overall Study STARTED	35	35
Overall Study COMPLETED	35	32
Overall Study NOT COMPLETED	0	3

Reasons for withdrawal

Measure	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. 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.	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. 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.
Overall Study Withdrawal by Subject	0	1
Overall Study Surgery Date Changed	0	2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Active Group n=35 Participants 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. 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.	Placebo Group n=32 Participants 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. 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.	Total n=67 Participants Total of all reporting groups
Age, Continuous	66 Years STANDARD_DEVIATION 7 • n=5 Participants	66 Years STANDARD_DEVIATION 9 • n=7 Participants	66 Years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	12 Participants n=7 Participants	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	32 Participants n=5 Participants	28 Participants n=7 Participants	60 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) White	27 Participants n=5 Participants	20 Participants n=7 Participants	47 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment United States	35 participants n=5 Participants	32 participants n=7 Participants	67 participants n=5 Participants
Operative site Left Side	19 Participants n=5 Participants	14 Participants n=7 Participants	33 Participants n=5 Participants
Operative site Right Side	16 Participants n=5 Participants	18 Participants n=7 Participants	34 Participants n=5 Participants
BMI (kg/m^2)	32.0 BMI (kg/m^2) STANDARD_DEVIATION 5.4 • n=5 Participants	30.5 BMI (kg/m^2) STANDARD_DEVIATION 5.3 • n=7 Participants	31 BMI (kg/m^2) STANDARD_DEVIATION 5.3 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Active Group n=35 Participants 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. 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.	Placebo Group n=32 Participants 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. 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.
Opioid Consumption After Surgery	192 Morphine Equivalents (ME) Interval 105.0 to 274.0	144 Morphine Equivalents (ME) Interval 112.0 to 314.0

SECONDARY outcome

Timeframe: Pre operative

The total morphine equivalent (milligrams) reported by the subject at baseline.

Outcome measures

Measure	Active Group n=35 Participants 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. 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.	Placebo Group n=32 Participants 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. 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.
Oral Morphine Equivalent Milligrams at Baseline.	0 milligrams Interval 0.0 to 0.0	0 milligrams Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: 48 hours

Total oral morphine equivalents at baseline compared to oral morphine equivalents at 48 hours post-operative.

Outcome measures

Measure	Active Group n=35 Participants 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. 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.	Placebo Group n=32 Participants 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. 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.
Oral Morphine Equivalents at Baseline Compared to 48 Hours Post-operative.	-187 Morphine Equivalents (ME) Interval -233.0 to -148.0	-191 Morphine Equivalents (ME) Interval -254.0 to -133.0

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Active Group n=35 Participants 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. 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.	Placebo Group n=32 Participants 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. 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.
Medication Quantification Scale III (MQSIII) Score 48 Hours Post-operative.	33 score on a scale Standard Deviation 8	35 score on a scale Standard Deviation 7

SECONDARY outcome

Timeframe: Post operative day 2

Number of stairs climbed on post-operative day 2 prior to discharge from the hospital.

Outcome measures

Measure	Active Group n=35 Participants 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. 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.	Placebo Group n=32 Participants 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. 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.
Number of Stairs Climbed on Post-operative Day 2.	7 stairs Standard Deviation 4	8 stairs Standard Deviation 5

SECONDARY outcome

Timeframe: Post operative day 2

Distance in feet walked on post-operative day 2 prior to discharge from the hospital.

Outcome measures

Measure	Active Group n=35 Participants 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. 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.	Placebo Group n=32 Participants 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. 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.
Distance Walked on Post-operative Day 2.	216 feet Standard Deviation 134	232 feet Standard Deviation 115

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Active Group n=35 Participants 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. 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.	Placebo Group n=32 Participants 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. 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.
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score 6 Months Post Operative	8 score on a scale Interval 4.0 to 22.0	9 score on a scale Interval 2.0 to 14.0

POST_HOC outcome

Timeframe: Baseline

Medication Quantification Scale Version III (MQSVIII) is a single value 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 at baseline in patients (the scale ranges from (0 low (good) 500 high) with Hospital Anxiety and Depression Scores (HADS) of less than 11.The Hospital Anxiety and Depression Scores (HADS) is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The questionnaire is scored from 0-3 and this means that a person can score between 0 (low) and 21 (high) for either anxiety or depression.

Outcome measures

Measure	Active Group n=32 Participants 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. 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.	Placebo Group n=29 Participants 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. 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.
Medication Quantification Scale Version III (MSQVIII) at Baseline in Patients With Hospital Anxiety and Depression Scores of Less Than 11.	6.5 score on a scale Interval 3.0 to 10.0	4 score on a scale Interval 2.0 to 10.0

POST_HOC outcome

Timeframe: 48 hours

Medication Quantification Scale Version III (MQSVIII) is a single value 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 score on a scale of 0 good-500 poor at baseline in patients with Hospital Anxiety and Depression Scores (HADS) of less than 11.The Hospital Anxiety and Depression Scores (HADS) is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The questionnaire is scored from 0-3 and this means that a person can score between 0 (low) and 21 (high) for either anxiety or depression.

Outcome measures

Measure	Active Group n=32 Participants 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. 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.	Placebo Group n=27 Participants 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. 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.
Medication Quantification Scale Version III (MSQVIII) at 48 Hours in Patients With Hospital Anxiety and Depression Scores of Less Than 11.	33.5 score on a scale Interval 28.0 to 37.0	34 score on a scale Interval 30.0 to 38.0

POST_HOC outcome

Timeframe: 1 month

Medication Quantification Scale Version III (MQSVIII) is a single value 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 (score on a scale 0 good-500 poor) at baseline in patients with Hospital Anxiety and Depression Scores (HADS) of less than 11.The Hospital Anxiety and Depression Scores (HADS) is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The questionnaire is scored from 0-3 and this means that a person can score between 0 (low) and 21 (high) for either anxiety or depression.

Outcome measures

Measure	Active Group n=32 Participants 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. 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.	Placebo Group n=27 Participants 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. 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.
Medication Quantification Scale Version III (MSQVIII) at 1 Month in Patients With Hospital Anxiety and Depression Scores of Less Than 11.	7 score on a scale Interval 3.0 to 7.5	5 score on a scale Interval 0.0 to 9.0

POST_HOC outcome

Timeframe: 6 month

Medication Quantification Scale Version III (MQSVIII) is a single value 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) at baseline in patients with Hospital Anxiety and Depression Scores (HADS) of less than 11.The Hospital Anxiety and Depression Scores (HADS) is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The questionnaire is scored from 0-3 and this means that a person can score between 0 (low) and 21 (high) for either anxiety or depression.

Outcome measures

Measure	Active Group n=29 Participants 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. 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.	Placebo Group n=27 Participants 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. 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.
Medication Quantification Scale Version III (MSQVIII) at 6 Months in Patients With Hospital Anxiety and Depression Scores of Less Than 11.	0 score on a scale Interval 0.0 to 0.0	0 score on a scale Interval 0.0 to 0.0

POST_HOC outcome

Timeframe: 3 months

Medication Quantification Scale Version III (MQSVIII) is a single value 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 (score on a scale 0 good-500 poor) at baseline in patients with Hospital Anxiety and Depression Scores (HADS) of less than 11.The Hospital Anxiety and Depression Scores (HADS) is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The questionnaire is scored from 0-3 and this means that a person can score between 0 (low) and 21 (high) for either anxiety or depression.

Outcome measures

Measure	Active Group n=32 Participants 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. 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.	Placebo Group n=27 Participants 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. 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.
Medication Quantification Scale Version III (MSQVIII) at 3 Months in Patients With Hospital Anxiety and Depression Scores of Less Than 11.	0 score on a scale Interval 0.0 to 4.5	0 score on a scale Interval 0.0 to 6.0

POST_HOC outcome

Timeframe: Baseline

Total oral morphine equivalents in milligrams at baseline in patients with Hospital Anxiety and Depression Scores (HADS) of less than 11.The Hospital Anxiety and Depression Scores (HADS) is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The questionnaire is scored from 0-3 and this means that a person can score between 0 (low) and 21 (high) for either anxiety or depression.

Outcome measures

Measure	Active Group n=32 Participants 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. 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.	Placebo Group n=29 Participants 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. 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.
Total Oral Morphine Equivalents in Milligrams at Baseline in Patients With Hospital Anxiety and Depression Scores (HADS) of Less Than 11.	0 milligrams Interval 0.0 to 0.0	0 milligrams Interval 0.0 to 0.0

POST_HOC outcome

Timeframe: 48 hours

Total oral morphine equivalents in milligrams at 48 hours in patients with Hospital Anxiety and Depression Scores (HADS) of less than 11.The Hospital Anxiety and Depression Scores (HADS) is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The questionnaire is scored from 0-3 and this means that a person can score between 0 (low) and 21 (high) for either anxiety or depression.

Outcome measures

Measure	Active Group n=32 Participants 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. 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.	Placebo Group n=29 Participants 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. 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.
Total Oral Morphine Equivalents in Milligrams at 48 Hours in Patients With Hospital Anxiety and Depression Scores (HADS) of Less Than 11.	178.5 milligrams Interval 92.5 to 267.0	138 milligrams Interval 110.0 to 328.0

POST_HOC outcome

Timeframe: 1 month post operative

Total oral morphine equivalents in milligrams at 1 month in patients with Hospital Anxiety and Depression Scores (HADS) of less than 11.The Hospital Anxiety and Depression Scores (HADS) is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The questionnaire is scored from 0-3 and this means that a person can score between 0 (low) and 21 (high) for either anxiety or depression.

Outcome measures

Measure	Active Group n=32 Participants 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. 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.	Placebo Group n=27 Participants 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. 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.
Total Oral Morphine Equivalents in Milligrams at 1 Month in Patients With Hospital Anxiety and Depression Scores (HADS) of Less Than 11.	10 milligrams Interval 1.0 to 20.0	5 milligrams Interval 0.0 to 10.0

POST_HOC outcome

Timeframe: 3 month post operative

Total oral morphine equivalents in milligrams at 3 months in patients with Hospital Anxiety and Depression Scores (HADS) of less than 11.The Hospital Anxiety and Depression Scores (HADS) is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The questionnaire is scored from 0-3 and this means that a person can score between 0 (low) and 21 (high) for either anxiety or depression.

Outcome measures

Measure	Active Group n=32 Participants 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. 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.	Placebo Group n=27 Participants 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. 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.
Total Oral Morphine Equivalents in Milligrams at 3 Months in Patients With Hospital Anxiety and Depression Scores (HADS) of Less Than 11.	0 milligrams Interval 0.0 to 4.0	0 milligrams Interval 0.0 to 2.0

POST_HOC outcome

Timeframe: 6 month post operative

Total oral morphine equivalents in milligrams at 6 months in patients with Hospital Anxiety and Depression Scores (HADS) of less than 11.The Hospital Anxiety and Depression Scores (HADS) is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The questionnaire is scored from 0-3 and this means that a person can score between 0 (low) and 21 (high) for either anxiety or depression.

Outcome measures

Measure	Active Group n=29 Participants 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. 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.	Placebo Group n=27 Participants 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. 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.
Total Oral Morphine Equivalents in Milligrams at 6 Months in Patients With Hospital Anxiety and Depression Scores (HADS) of Less Than 11.	0 Milligrams Interval 0.0 to 0.0	0 Milligrams Interval 0.0 to 0.0

POST_HOC outcome

Timeframe: Baseline

WOMAC score at baseline in patients with Hospital Anxiety and Depression Scale (HADS) Scores of less than 11.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). Summed for a combined WOMAC score of 0 (low) to 96 (high) Higher scores indicate worse pain, stiffness, and functional limitation. The Hospital Anxiety and Depression Scores (HADS) is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression.The questionnaire is scored from 0-3 and this means that a person can score between 0 (low) and 21 (high) for either anxiety or depression.

Outcome measures

Measure	Active Group n=32 Participants 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. 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.	Placebo Group n=29 Participants 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. 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.
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at Baseline in Patients With Hospital Anxiety and Depression Scale (HADS) Scores of Less Than 11.	39.5 score on a scale Interval 32.5 to 52.0	40 score on a scale Interval 22.0 to 48.0

POST_HOC outcome

Timeframe: 1 month post operative

WOMAC score at 1 month in patients with Hospital Anxiety and Depression Scale (HADS) Scores of less than 11.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). Summed for a combined WOMAC score of 0 (low) to 96 (high) Higher scores indicate worse pain, stiffness, and functional limitation. The Hospital Anxiety and Depression Scores (HADS) is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression.The questionnaire is scored from 0-3 and this means that a person can score between 0 (low) and 21 (high) for either anxiety or depression.

Outcome measures

Measure	Active Group n=32 Participants 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. 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.	Placebo Group n=27 Participants 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. 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.
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 1 Month in Patients With Hospital Anxiety and Depression Scale (HADS) Scores of Less Than 11.	21 score on a scale Interval 14.0 to 28.0	13 score on a scale Interval 8.0 to 22.0

POST_HOC outcome

Timeframe: 3 month post operative

WOMAC score at 3 months in patients with Hospital Anxiety and Depression Scale (HADS) Scores of less than 11.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). Summed for a combined WOMAC score of 0 (low) to 96 (high) Higher scores indicate worse pain, stiffness, and functional limitation. The Hospital Anxiety and Depression Scores (HADS) is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression.The questionnaire is scored from 0-3 and this means that a person can score between 0 (low) and 21 (high) for either anxiety or depression.

Outcome measures

Measure	Active Group n=29 Participants 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. 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.	Placebo Group n=27 Participants 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. 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.
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 3 Month in Patients With Hospital Anxiety and Depression Scale (HADS) Scores of Less Than 11.	11.5 score on a scale Interval 6.0 to 23.5	8 score on a scale Interval 2.0 to 17.0

POST_HOC outcome

Timeframe: 6 month post operative

WOMAC score at 6 months in patients with Hospital Anxiety and Depression Scale (HADS) Scores of less than 11.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). Summed for a combined WOMAC score of 0 (low) to 96 (high) Higher scores indicate worse pain, stiffness, and functional limitation. The Hospital Anxiety and Depression Scores (HADS) is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression.The questionnaire is scored from 0-3 and this means that a person can score between 0 (low) and 21 (high) for either anxiety or depression.

Outcome measures

Measure	Active Group n=29 Participants 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. 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.	Placebo Group n=27 Participants 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. 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.
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 6 Month in Patients With Hospital Anxiety and Depression Scale (HADS) Scores of Less Than 11.	9 score on a scale Interval 4.0 to 20.0	9 score on a scale Interval 1.0 to 14.0

Adverse Events

Active Group

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Placebo Group

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Active Group n=35 participants at risk 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. 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.	Placebo Group n=32 participants at risk 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. 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.
Gastrointestinal disorders Nausea	22.9% 8/35 • Number of events 8 • Collection of adverse events 48 hours after total knee arthroplasty.	28.1% 9/32 • Number of events 9 • Collection of adverse events 48 hours after total knee arthroplasty.
Skin and subcutaneous tissue disorders Puritis	22.9% 8/35 • Number of events 8 • Collection of adverse events 48 hours after total knee arthroplasty.	28.1% 9/32 • Number of events 9 • Collection of adverse events 48 hours after total knee arthroplasty.

Additional Information

David Walega, MD

Northwestern University

Phone: 312-695-0061

Email: d-walega@northwestern.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place