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| Name | Class |
|---|---|
| Halyard Health | INDUSTRY |
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To prove that total knee arthroplasty can be performed with little, if any need for opioids by using a combination of patient education, optimized pre-op and post-op pain and recovery protocols. The goal being opioid-free total knee arthroplasty.
All study patients will receive a standardized protocol
Methods:
Pre-op Optimization
Total Joint Procedure
Data Collection
Pain Management Regimen
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| opioids | Other | dosage frequency and duration |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Total Knee Replacement Performed Without Opioids Through 12 Weeks Postoperative | Using a combination of patient education, optimized pre-operative and post-operative pain protocols and optimized recovery protocols | 12 weeks |
| Number of Patients With Total Knee Arthroplasty Performed With Opiate Drugs Through 12 Weeks Postoperative | The total number of opioid tablets taken by patient after total knee arthroplasty performed through 12 weeks postoperative | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity | Pain level is measured by the Numerical Rating Scale (NRS) for pain utilizing minimum number 0 to maximum number 10 (0 represents no pain and 10 represents worst pain imaginable). The higher the number reported the worst the pain/outcome. This will be used to assess patient's level of pain relating to opioid use and recovery. |
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Inclusion Criteria:
Exclusion Criteria:
Schizophrenia Bipolar Disease Dementia
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A Partial and total knee arthroplasty Unilateral only
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| Name | Affiliation | Role |
|---|---|---|
| Andrew B Wickline, MD | St Elizabeth Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Elizabeth Medical Center | Utica | New York | 13501 | United States |
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All patients to have total knee arthroplasty. All patients have optimized BMI, hemoglobin, albumin, glucose control-A1C and blood pressure. All patients enrolled in educational program. All patients have pre-op physical therapy teaching.
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| ID | Title | Description |
|---|---|---|
| FG000 | Total Knee Arthoplasty | All study patients received the same surgical procedure by the same surgeon, using same implants, approach, pre and post-optimization and a simplified pain protocol at a single hospital or surgery center. The number of opioid tablets taken by each patient was calculated from electronic medical record chart review, post anesthesia care unit, nursing care prior to discharge, phone calls after discharge and follow-up in surgeon's office. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Total Knee Arthroplasty | Number of patients that had total knee arthroplasty after meeting study inclusion criteria |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients With Total Knee Replacement Performed Without Opioids Through 12 Weeks Postoperative | Using a combination of patient education, optimized pre-operative and post-operative pain protocols and optimized recovery protocols | Number of patents that took no opioids after total knee arthroplasty 12 weeks post surgery | Posted | Count of Participants | Participants | 12 weeks |
|
12 weeks
Adverse events were events that occurred from day of surgery through 12 week post-surgery.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Total Knee Arthoplasty | All study patients received the same surgical procedure by the same surgeon, using same implants, approach, pre and post-optimization and a simplified pain protocol at a single hospital or surgery center. The number of opioid tablets taken by each patient was calculated from electronic medical record chart review, post anesthesia care unit, nursing care prior to discharge, phone calls after discharge and follow-up in surgeon's office. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| infection | Infections and infestations | Systematic Assessment | patient had post surgery incision and drainage of acute total knee arthroplasty infection week 4 and placed on antibiotics. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| bleeding | Skin and subcutaneous tissue disorders | Non-systematic Assessment | bleeding from suture site which required a pressure bandage to control further bleeding |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Andrew Wickline | St Elizabeth Medical Center | 315-735-4496 | awickline23@gmail.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 30, 2020 | May 11, 2020 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D000701 | Analgesics, Opioid |
| ID | Term |
|---|---|
| D009294 | Narcotics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
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| postoperative days 1,2,3,postoperative day 10-14, 3 weeks post surgery, 6 weeks post surgery and 12 weeks post surgery |
| Knee Injury and Osteoarthritis Outcome Score Short Form (KOOS JR) | The Knee Injury and Osteoarthritis Outcome Score Short Form (KOOS JR) is a survey that is an assessment and questionnaire that rates a patients joint pain, stiffness and function in daily living. Patients answer questions about joint stiffness, pain and daily activities using the following scoring values: 0=none, 1=mild, 2=moderate, 3=severe, 4=extreme. The values for all questions are added up to get a raw score that ranges from a minimum of 0 to a maximum of 28. This raw score is converted to an interval score using a provided table. The interval score ranges from a minimum of 0 to a maximum of 100 where 0 = total knee disability and 100 = perfect knee health. The higher the score on scale from 0 to 100 the better the outcome. | Baseline (preoperative); 6 weeks post surgery; 12 weeks post surgery |
| Number of Participants Using Swift Path Educational Tool as Outpatients for Total Joint Replacement | Swift path is an Educational tool (diary) for patients undergoing total joint replacement, that patients follow from the initial booking of surgery through their recovery. It guides patients through potential risks involved with joint surgery, through a multimodal pain management protocol for pain prevention and through recovery. | 6 weeks |
| Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Days 10-14 | Exercise protocol for patients after total knee replacement where the patient performs a series of exercises every hour to help prevent blood clots and achieve appropriate range of motion goals. | Postop Days10-14 |
| Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Week 3 | Exercise protocol for patients after total knee replacement where the patient performs a series of exercises every hour to help prevent blood clots and achieve appropriate range of motion goals. | postoperative 3 weeks |
| Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Week 6 | Exercise protocol for patients after total knee replacement where the patient performs a series of exercises every hour to help prevent blood clots and achieve appropriate range of motion goals. | Postoperative 6 weeks |
| Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Post Week 12 | Exercise protocol for patients after total knee replacement where the patient performs a series of exercises every hour to help prevent blood clots and achieve appropriate range of motion goals. | Postoperative 12 weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m² |
|
| ASA | American Society of Anesthesiologists physical status classification system for assessing the fitness of patients before surgery. ASA I = normal healthy patient. ASA II = patient with mild systemic disease. ASA III = patient with severe systemic disease. ASA IV = patient with severe systemic disease that is a constant threat to life. | Number analyzed different from overall participants due to missing data from anesthesiologist record prior to surgery. | Number | participants |
|
|
|
| Primary | Number of Patients With Total Knee Arthroplasty Performed With Opiate Drugs Through 12 Weeks Postoperative | The total number of opioid tablets taken by patient after total knee arthroplasty performed through 12 weeks postoperative | Number of Participants Stratified by Total Quantity of Opioid Tablets Taken Post Total Knee Replacement | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| Secondary | Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity | Pain level is measured by the Numerical Rating Scale (NRS) for pain utilizing minimum number 0 to maximum number 10 (0 represents no pain and 10 represents worst pain imaginable). The higher the number reported the worst the pain/outcome. This will be used to assess patient's level of pain relating to opioid use and recovery. | 386 patients analyzed through 6 weeks; 340 patients analyzed at 12 weeks only. | Posted | Mean | Standard Deviation | score on a scale | postoperative days 1,2,3,postoperative day 10-14, 3 weeks post surgery, 6 weeks post surgery and 12 weeks post surgery |
|
|
|
|
| Secondary | Knee Injury and Osteoarthritis Outcome Score Short Form (KOOS JR) | The Knee Injury and Osteoarthritis Outcome Score Short Form (KOOS JR) is a survey that is an assessment and questionnaire that rates a patients joint pain, stiffness and function in daily living. Patients answer questions about joint stiffness, pain and daily activities using the following scoring values: 0=none, 1=mild, 2=moderate, 3=severe, 4=extreme. The values for all questions are added up to get a raw score that ranges from a minimum of 0 to a maximum of 28. This raw score is converted to an interval score using a provided table. The interval score ranges from a minimum of 0 to a maximum of 100 where 0 = total knee disability and 100 = perfect knee health. The higher the score on scale from 0 to 100 the better the outcome. | 311 patients reported KOOS JR scores at baseline which was prior to surgery. At 6 weeks 379 patients reported scores. At 12 weeks 341 patients reported scores. | Posted | Mean | Standard Deviation | score on a scale | Baseline (preoperative); 6 weeks post surgery; 12 weeks post surgery |
|
|
|
| Secondary | Number of Participants Using Swift Path Educational Tool as Outpatients for Total Joint Replacement | Swift path is an Educational tool (diary) for patients undergoing total joint replacement, that patients follow from the initial booking of surgery through their recovery. It guides patients through potential risks involved with joint surgery, through a multimodal pain management protocol for pain prevention and through recovery. | Posted | Count of Participants | Participants | 6 weeks |
|
|
|
| Secondary | Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Days 10-14 | Exercise protocol for patients after total knee replacement where the patient performs a series of exercises every hour to help prevent blood clots and achieve appropriate range of motion goals. | Physical therapy adherence for patients not taking opioids and taking opioids at 10-14 day follow-up visit | Posted | Count of Participants | Participants | Postop Days10-14 |
|
|
|
|
| Secondary | Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Week 3 | Exercise protocol for patients after total knee replacement where the patient performs a series of exercises every hour to help prevent blood clots and achieve appropriate range of motion goals. | Physical therapy adherence for patients not taking opioids and taking opioids at 3 week follow-up visit | Posted | Count of Participants | Participants | postoperative 3 weeks |
|
|
|
|
| Secondary | Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Week 6 | Exercise protocol for patients after total knee replacement where the patient performs a series of exercises every hour to help prevent blood clots and achieve appropriate range of motion goals. | Physical therapy adherence for patients not taking opioids and taking opioids at 6 week follow-up visit | Posted | Count of Participants | Participants | Postoperative 6 weeks |
|
|
|
|
| Secondary | Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Post Week 12 | Exercise protocol for patients after total knee replacement where the patient performs a series of exercises every hour to help prevent blood clots and achieve appropriate range of motion goals. | Physical therapy adherence for patients not taking opioids and taking opioids at 12 week follow-up visit | Posted | Count of Participants | Participants | Postoperative 12 weeks |
|
|
|
|
| 0 |
| 386 |
| 4 |
| 386 |
| 33 |
| 386 |
|
| right quadricep repair | Musculoskeletal and connective tissue disorders | Systematic Assessment | patient experienced right quadriceps repair which was torn during formal physical therapy post surgery week 8 |
|
| bowel obstruction | Gastrointestinal disorders | Systematic Assessment | not related to surgery Patient had a history of bowel obstruction |
|
| pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | unrelated to surgery occurred during patient rehab stay |
|
|
| fall | Social circumstances | Non-systematic Assessment | patient reported a fall (none resulted in an intervention or injuries) |
|
| motor weakness | Surgical and medical procedures | Non-systematic Assessment | motor weakness due to adductor canal anesthesia/numbness |
|
| paresthesia | Nervous system disorders | Non-systematic Assessment | persistent patient had history of multiple sclerosis prior to surgery |
|
| uncontrolled pain | Surgical and medical procedures | Non-systematic Assessment | persistent pain post surgery which included nerve pain and burning |
|
| early pain ball catheter removal by patient | Surgical and medical procedures | Non-systematic Assessment | patients removed pain ball prior to completion due to leakage or mechanical problem |
|
| inadvertent pain ball catheter removal | Surgical and medical procedures | Non-systematic Assessment | patient removed pain ball or disconnected pain ball by mistake |
|
| persistent numbness | Nervous system disorders | Non-systematic Assessment | patient experiencing numbness to touch |
|
| manipulation of knee joint | Musculoskeletal and connective tissue disorders | Systematic Assessment | patients required manipulation of knee joint due to poor range of motion of knee post surgery |
|
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| D020164 | Chemical Actions and Uses |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| >10 tablets |
|
|
| Postoperative Day 1 - Best with Activity |
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| Postoperative Day 1 - Worst with Activity |
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| Postoperative Day 2 - Best at Rest |
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| Postoperative Day 2 - Worst at Rest |
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| Postoperative Day 2 - Best with Activity |
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| Postoperative Day 2 - Worst with Activity |
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| Postoperative Day 3 - Best at Rest |
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| Postoperative Day 3 - Worst at Rest |
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| Postoperative Day 3 - Best with Activity |
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| Postoperative Day 3 - Worst with Activity |
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| Postoperative Days 10-14 - Best at Rest |
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| Postoperative Days 10-14 - Worst at Rest |
|
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| Postoperative Days 10-14 - Best with Activity |
|
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| Postoperative Days 10-14 Worst with Activity |
|
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| Postoperative Week 3 - Best at Rest |
|
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| Postoperative Week 3 - Worst at Rest |
|
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| Postoperative Week 3- Best with Activity |
|
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| Postoperative Week 3 - Worst with Activity |
|
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| Postoperative Week 6 - Best at Rest |
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| Postoperative Week 6 - Worst at Rest |
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| Postoperative Week 6 - Best with Activity |
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| Postoperative Week 6 - Worst with Activity |
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| Postoperative Week 12 - Best at Rest |
|
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| Postoperative Week 12 - Worst at Rest |
|
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| Postoperative Week 12 - Best with Activity |
|
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| Postoperative Week 12 - Worst with Activity |
|
|
Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity. |
| mean score |
| 2.4 |
| 2-Sided |
| 95 |
| 2.2 |
| 2.6 |
Represents patients reported pain score post operative day 1 worst at rest |
| Other |
| Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity | mean score | 2.9 | 2-Sided | 95 | 2.7 | 3.1 | Represents patients reported pain score post operative day 1 best with activity | Other |
| Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity | mean score | 4.6 | 2-Sided | 95 | 4.4 | 4.8 | Represents patients reported pain score post operative day 1 worst with activity | Other |
| Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity | mean score | 1.8 | 2-Sided | 95 | 1.6 | 2.0 | Represents patients reported pain score post operative day 2 best at rest | Other |
| Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity | mean score | 3.4 | 2-Sided | 95 | 3.2 | 3.6 | Represents patients reported pain score post operative day 2 worst at rest | Other |
| Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity | mean score | 4.2 | 2-Sided | 95 | 4.0 | 4.4 | Represents patients reported pain score post operative day 2 best with activity | Other |
| Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity | mean score | 5.9 | 2-Sided | 95 | 5.7 | 6.1 | Represents patients reported pain score post operative day 2 worst with activity | Other |
| Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity | mean score | 1.0 | 2-Sided | 95 | 0.8 | 1.2 | Represents patients reported pain score post operative day 3 best at rest | Other |
| Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity | mean score | 2.4 | 2-Sided | 95 | 2.2 | 2.6 | Represents patients reported pain score post operative day 3 worst at rest | Other |
| Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity | mean score | 3.3 | 2-Sided | 95 | 3.1 | 3.5 | Represents patients reported pain score post operative day 3 best with activity | Other |
| Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity | mean score | 5.0 | 2-Sided | 95 | 4.8 | 5.2 | Represents patients reported pain score post operative day 3 worst with activity | Other |
| Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity | mean score | 0.5 | 2-Sided | 95 | 0.4 | 0.7 | Represents patients reported pain score post operative days 10-14 best at rest | Other |
| Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity | mean score | 2.1 | 2-Sided | 95 | 1.9 | 2.3 | Represents patients reported pain score post operative days 10-14 worst at rest | Other |
| Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity | mean score | 2.0 | 2-Sided | 95 | 1.8 | 2.2 | Represents patients reported pain score post operative days 10-14 best with activity | Other |
| Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity | mean score | 4.0 | 2-Sided | 95 | 3.8 | 4.2 | Represents patients reported pain score post operative days 10-14 worst with activity | Other |
| Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity | mean score | 0.3 | 2-Sided | 95 | 0.2 | 0.4 | Represents patients reported pain score post operative week 3 best at rest | Other |
| Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity | mean score | 1.5 | 2-Sided | 95 | 1.3 | 1.7 | Represents patients reported pain score post operative week 3 worst at rest | Other |
| Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity | mean score | 1.3 | 2-Sided | 95 | 1.2 | 1.5 | Represents patients reported pain score post operative week 3 best with activity | Other |
| Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity | mean score | 3.1 | 2-Sided | 95 | 2.9 | 3.3 | Represents patients reported pain score post operative week 3 worst with activity | Other |
| Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity | mean score | 0.1 | 2-Sided | 95 | 0.0 | 0.2 | Represents patients reported pain score post operative week 6 best at rest | Other |
| Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity | mean score | 0.7 | 2-Sided | 95 | 0.5 | 0.8 | Represents patients reported pain score post operative week 6 worst at rest | Other |
| Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity | mean score | 0.5 | 2-Sided | 95 | 0.4 | 0.6 | Represents patients reported pain score post operative week 6 best with activity | Other |
| Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity | mean score | 1.9 | 2-Sided | 95 | 1.7 | 2.0 | Represents patients reported pain score post operative week 6 worst with activity | Other |
| Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity | mean score | 0.0 | 2-Sided | 95 | -0.0 | 0.0 | Represents patients reported pain score post operative week 12 best at rest | Other |
| Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity | mean score | 0.2 | 2-Sided | 95 | 0.1 | 0.2 | Represents patients reported pain score post operative week 12 worst at rest | Other |
| Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity | mean score | 0.0 | 2-Sided | 95 | -0.0 | 0.1 | Represents patients reported pain score post operative week 12 best with activity | Other |
| Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity | mean score | 0.5 | 2-Sided | 95 | 0.4 | 0.7 | Represents patients reported pain score post operative week 12 worst with activity | Other |
|
| Postoperative 12 Week |
|
|