| Primary | Opioid Consumption After Surgery | 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. | | Posted | | Median | Inter-Quartile Range | Morphine Equivalents (ME) | | 48 hours | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000192(105 to 274)
- OG001144(112 to 314)
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Wilcoxon (Mann-Whitney) | | .978 | | | | | | | | | | | | | | Superiority | | |
|
| Secondary | Oral Morphine Equivalent Milligrams at Baseline. | The total morphine equivalent (milligrams) reported by the subject at baseline. | | Posted | | Median | Inter-Quartile Range | milligrams | | Pre operative | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Secondary | Oral Morphine Equivalents at Baseline Compared to 48 Hours Post-operative. | Total oral morphine equivalents at baseline compared to oral morphine equivalents at 48 hours post-operative. | | Posted | | Median | Inter-Quartile Range | Morphine Equivalents (ME) | | 48 hours | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Secondary | Medication Quantification Scale III (MQSIII) Score 48 Hours Post-operative. | 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). | | Posted | | Median | Standard Deviation | score on a scale | | 48 hours | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Placebo Group |
|
| Secondary | Number of Stairs Climbed on Post-operative Day 2. | Number of stairs climbed on post-operative day 2 prior to discharge from the hospital. | | Posted | | Mean | Standard Deviation | stairs | | Post operative day 2 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Secondary | Distance Walked on Post-operative Day 2. | Distance in feet walked on post-operative day 2 prior to discharge from the hospital. | | Posted | | Mean | Standard Deviation | feet | | Post operative day 2 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Secondary | Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score 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. | | Posted | | Median | Inter-Quartile Range | score on a scale | | 6 months post operative | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Placebo Group |
|
| Post-Hoc | Medication Quantification Scale Version III (MSQVIII) at Baseline in Patients With Hospital Anxiety and Depression Scores of Less Than 11. | 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. | | Posted | | Median | Inter-Quartile Range | score on a scale | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | 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. |
|
| Post-Hoc | Medication Quantification Scale Version III (MSQVIII) at 48 Hours in Patients With Hospital Anxiety and Depression Scores of Less Than 11. | 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. | | Posted | | Median | Inter-Quartile Range | score on a scale | | 48 hours | | | | ID | Title | Description |
|---|
| OG000 | 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. |
|
| Post-Hoc | Medication Quantification Scale Version III (MSQVIII) at 1 Month in Patients With Hospital Anxiety and Depression Scores of Less Than 11. | 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. | | Posted | | Median | Inter-Quartile Range | score on a scale | | 1 month | | | | ID | Title | Description |
|---|
| OG000 | 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. |
|
| Post-Hoc | Medication Quantification Scale Version III (MSQVIII) at 6 Months in Patients With Hospital Anxiety and Depression Scores of Less Than 11. | 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. | | Posted | | Median | Inter-Quartile Range | score on a scale | | 6 month | | | | ID | Title | Description |
|---|
| OG000 | 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. |
|
| Post-Hoc | Medication Quantification Scale Version III (MSQVIII) at 3 Months in Patients With Hospital Anxiety and Depression Scores of Less Than 11. | 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. | | Posted | | Median | Inter-Quartile Range | score on a scale | | 3 months | | | | ID | Title | Description |
|---|
| OG000 | 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. |
|
| Post-Hoc | Total Oral Morphine Equivalents in Milligrams at Baseline in Patients With Hospital Anxiety and Depression Scores (HADS) of Less Than 11. | 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. | | Posted | | Median | Inter-Quartile Range | milligrams | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Post-Hoc | Total Oral Morphine Equivalents in Milligrams at 48 Hours in Patients With Hospital Anxiety and Depression Scores (HADS) of Less Than 11. | 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. | | Posted | | Median | Inter-Quartile Range | milligrams | | 48 hours | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Post-Hoc | Total Oral Morphine Equivalents in Milligrams at 1 Month in Patients With Hospital Anxiety and Depression Scores (HADS) of Less Than 11. | 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. | | Posted | | Median | Inter-Quartile Range | milligrams | | 1 month post operative | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Post-Hoc | Total Oral Morphine Equivalents in Milligrams at 3 Months in Patients With Hospital Anxiety and Depression Scores (HADS) of Less Than 11. | 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. | | Posted | | Median | Inter-Quartile Range | milligrams | | 3 month post operative | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Post-Hoc | Total Oral Morphine Equivalents in Milligrams at 6 Months in Patients With Hospital Anxiety and Depression Scores (HADS) of Less Than 11. | 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. | | Posted | | Median | Inter-Quartile Range | Milligrams | | 6 month post operative | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Post-Hoc | 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. | 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. | | Posted | | Median | Inter-Quartile Range | score on a scale | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | 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. |
|
| Post-Hoc | 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. | 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. | | Posted | | Median | Inter-Quartile Range | score on a scale | | 1 month post operative | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| Post-Hoc | 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. | 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. | | Posted | | Median | Inter-Quartile Range | score on a scale | | 3 month post operative | | | | ID | Title | Description |
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| OG000 | 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. |
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| Post-Hoc | 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. | 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. | | Posted | | Median | Inter-Quartile Range | score on a scale | | 6 month post operative | | | | ID | Title | Description |
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| OG000 | 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. |
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