Arthroplasty, Replacement, Knee
Conditions
Keywords
Total Knee Replacement, Replacement of the knee joint,
Brief summary
More than 300,000 total knee joint replacement surgeries are performed per year in the United States and safe, effective management of post-operative pain in these patients, often elderly, deconditioned, obese, or with co-morbid diseases like sleep apnea, can be challenging and often require a multidisciplinary, multimodal approach. Opiates have been a mainstay of treatment in the post-operative period with varying degrees of success and complications. Inadequately controlled postoperative pain is not uncommon. Poorly controlled pain inhibits early mobilization and hinders post-operative physical therapy. A new paradigm for treating post-operative pain following total knee replacement may be the use of cooled radiofrequency ablation (C-RFA) of the articular sensory nerve supply of the knee capsule prior to surgery, to desensitize the knee by blocking sensory afferents to the anterior capsule and thereby decrease post-operative pain. There are several publications that have demonstrated the use of RFA in patients with chronic knee pain from osteoarthritis however the use of RFA in the preoperative management of pain in patients undergoing total knee joint replacement has not been investigated. The aim of this study is to determine if patients undergoing unilateral total knee replacement obtain any post-operative pain relieving benefits from C-RFA of the articular sensory nerve supply when performed prior to surgery, as compared to sham controls who receive only local anesthetic injections of these same nerves without the benefit of ablation treatment.
Interventions
PROCEDURERadiofrequency 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.
PROCEDURESimulated 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.
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* osteoarthritis of the knee scheduled to undergo their first unilateral knee joint replacement * willingness to undergo fluoroscopy-guided C-RFA or sham treatment
Exclusion criteria
* pregnancy, * severe cardiac/pulmonary compromise, * acute illness/infection, * coagulopathy * bleeding disorder, * allergic reactions, * contraindications to a local anesthetic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Consumption After Surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oral Morphine Equivalents at Baseline Compared to 48 Hours Post-operative. | 48 hours | Total oral morphine equivalents at baseline compared to oral morphine equivalents at 48 hours post-operative. |
| Medication Quantification Scale III (MQSIII) Score 48 Hours Post-operative. | 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). |
| Oral Morphine Equivalent Milligrams at Baseline. | Pre operative | The total morphine equivalent (milligrams) reported by the subject at baseline. |
| Distance Walked on Post-operative Day 2. | Post operative day 2 | Distance in feet walked on post-operative day 2 prior to discharge from the hospital. |
| Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score 6 Months Post Operative | 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. |
| Number of Stairs Climbed on Post-operative Day 2. | Post operative day 2 | Number of stairs climbed on post-operative day 2 prior to discharge from the hospital. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 35 |
| 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. | 32 |
| Total | 67 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Surgery Date Changed | 0 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Active Group | Total | Placebo Group |
|---|---|---|---|
| Age, Continuous | 66 Years STANDARD_DEVIATION 7 | 66 Years STANDARD_DEVIATION 8 | 66 Years STANDARD_DEVIATION 9 |
| BMI (kg/m^2) | 32.0 BMI (kg/m^2) STANDARD_DEVIATION 5.4 | 31 BMI (kg/m^2) STANDARD_DEVIATION 5.3 | 30.5 BMI (kg/m^2) STANDARD_DEVIATION 5.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 7 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants | 60 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Operative site Left Side | 19 Participants | 33 Participants | 14 Participants |
| Operative site Right Side | 16 Participants | 34 Participants | 18 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 13 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 7 Participants | 4 Participants |
| Race (NIH/OMB) White | 27 Participants | 47 Participants | 20 Participants |
| Region of Enrollment United States | 35 participants | 67 participants | 32 participants |
| Sex: Female, Male Female | 20 Participants | 40 Participants | 20 Participants |
| Sex: Female, Male Male | 15 Participants | 27 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 32 |
| other Total, other adverse events | 8 / 35 | 9 / 32 |
| serious Total, serious adverse events | 0 / 35 | 0 / 32 |
Outcome results
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.
Time frame: 48 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Active Group | Opioid Consumption After Surgery | 192 Morphine Equivalents (ME) |
| Placebo Group | Opioid Consumption After Surgery | 144 Morphine Equivalents (ME) |
p-value: 0.978Wilcoxon (Mann-Whitney)
Secondary
Distance Walked on Post-operative Day 2.
Distance in feet walked on post-operative day 2 prior to discharge from the hospital.
Time frame: Post operative day 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Group | Distance Walked on Post-operative Day 2. | 216 feet | Standard Deviation 134 |
| Placebo Group | Distance Walked on Post-operative Day 2. | 232 feet | Standard Deviation 115 |
p-value: 0.466t-test, 2 sided
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).
Time frame: 48 hours
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Active Group | Medication Quantification Scale III (MQSIII) Score 48 Hours Post-operative. | 33 score on a scale | Standard Deviation 8 |
| Placebo Group | Medication Quantification Scale III (MQSIII) Score 48 Hours Post-operative. | 35 score on a scale | Standard Deviation 7 |
p-value: 0.371t-test, 2 sided
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.
Time frame: Post operative day 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Group | Number of Stairs Climbed on Post-operative Day 2. | 7 stairs | Standard Deviation 4 |
| Placebo Group | Number of Stairs Climbed on Post-operative Day 2. | 8 stairs | Standard Deviation 5 |
p-value: 0.325t-test, 2 sided
Secondary
Oral Morphine Equivalent Milligrams at Baseline.
The total morphine equivalent (milligrams) reported by the subject at baseline.
Time frame: Pre operative
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Active Group | Oral Morphine Equivalent Milligrams at Baseline. | 0 milligrams |
| Placebo Group | Oral Morphine Equivalent Milligrams at Baseline. | 0 milligrams |
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.
Time frame: 48 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Active Group | Oral Morphine Equivalents at Baseline Compared to 48 Hours Post-operative. | -187 Morphine Equivalents (ME) |
| Placebo Group | Oral Morphine Equivalents at Baseline Compared to 48 Hours Post-operative. | -191 Morphine Equivalents (ME) |
p-value: 0.978Wilcoxon (Mann-Whitney)
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.
Time frame: 6 months post operative
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Active Group | Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score 6 Months Post Operative | 8 score on a scale |
| Placebo Group | Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score 6 Months Post Operative | 9 score on a scale |
p-value: 0.368Wilcoxon (Mann-Whitney)
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.
Time frame: 1 month
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Active Group | 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 |
| Placebo Group | Medication Quantification Scale Version III (MSQVIII) at 1 Month in Patients With Hospital Anxiety and Depression Scores of Less Than 11. | 5 score on a scale |
p-value: 0.687Wilcoxon (Mann-Whitney)
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.
Time frame: 3 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Active Group | 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 |
| Placebo Group | 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 |
p-value: 0.687Wilcoxon (Mann-Whitney)
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.
Time frame: 48 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Active Group | 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 |
| Placebo Group | Medication Quantification Scale Version III (MSQVIII) at 48 Hours in Patients With Hospital Anxiety and Depression Scores of Less Than 11. | 34 score on a scale |
p-value: 0.593Wilcoxon (Mann-Whitney)
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.
Time frame: 6 month
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Active Group | 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 |
| Placebo Group | 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 |
p-value: 0.813Wilcoxon (Mann-Whitney)
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.
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Active Group | 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 |
| Placebo Group | Medication Quantification Scale Version III (MSQVIII) at Baseline in Patients With Hospital Anxiety and Depression Scores of Less Than 11. | 4 score on a scale |
p-value: 0.509Wilcoxon (Mann-Whitney)
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.
Time frame: 1 month post operative
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Active Group | Total Oral Morphine Equivalents in Milligrams at 1 Month in Patients With Hospital Anxiety and Depression Scores (HADS) of Less Than 11. | 10 milligrams |
| Placebo Group | Total Oral Morphine Equivalents in Milligrams at 1 Month in Patients With Hospital Anxiety and Depression Scores (HADS) of Less Than 11. | 5 milligrams |
p-value: 0.301Wilcoxon (Mann-Whitney)
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.
Time frame: 3 month post operative
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Active Group | Total Oral Morphine Equivalents in Milligrams at 3 Months in Patients With Hospital Anxiety and Depression Scores (HADS) of Less Than 11. | 0 milligrams |
| Placebo Group | Total Oral Morphine Equivalents in Milligrams at 3 Months in Patients With Hospital Anxiety and Depression Scores (HADS) of Less Than 11. | 0 milligrams |
p-value: 0.826Wilcoxon (Mann-Whitney)
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.
Time frame: 48 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Active Group | 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 |
| Placebo Group | Total Oral Morphine Equivalents in Milligrams at 48 Hours in Patients With Hospital Anxiety and Depression Scores (HADS) of Less Than 11. | 138 milligrams |
p-value: 0.913Wilcoxon (Mann-Whitney)
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.
Time frame: 6 month post operative
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Active Group | Total Oral Morphine Equivalents in Milligrams at 6 Months in Patients With Hospital Anxiety and Depression Scores (HADS) of Less Than 11. | 0 Milligrams |
| Placebo Group | Total Oral Morphine Equivalents in Milligrams at 6 Months in Patients With Hospital Anxiety and Depression Scores (HADS) of Less Than 11. | 0 Milligrams |
p-value: 0.813Wilcoxon (Mann-Whitney)
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.
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Active Group | Total Oral Morphine Equivalents in Milligrams at Baseline in Patients With Hospital Anxiety and Depression Scores (HADS) of Less Than 11. | 0 milligrams |
| Placebo Group | Total Oral Morphine Equivalents in Milligrams at Baseline in Patients With Hospital Anxiety and Depression Scores (HADS) of Less Than 11. | 0 milligrams |
p-value: 0.84Wilcoxon (Mann-Whitney)
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.
Time frame: 1 month post operative
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Active Group | 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 |
| Placebo Group | 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. | 13 score on a scale |
p-value: 0.047Wilcoxon (Mann-Whitney)
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.
Time frame: 3 month post operative
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Active Group | 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 |
| Placebo Group | 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. | 8 score on a scale |
p-value: 0.115Wilcoxon (Mann-Whitney)
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.
Time frame: 6 month post operative
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Active Group | 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 |
| Placebo Group | 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 |
p-value: 0.349Wilcoxon (Mann-Whitney)
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.
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Active Group | 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 |
| Placebo Group | 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. | 40 score on a scale |