Opioid-free Accelerated Recovery Total Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
All study patients will receive a standardized protocol All surgical procedures performed by single surgeon using same implants, approach, pre-op and post-op optimization, and simplified pain protocol at a single hospital or surgery center Will attempt to minimize the number of anesthesiologists to further control variability in care Methods: Pre-op Optimization All patients enroll in education program All patients have optimized BMI, hemoglobin, albumin, glucose control-A1C, and blood pressure Total Joint Procedure Tourniquet-free cemented total knee arthroplasty is performed with intra-articular block Data Collection Electronic medical record chart review Pre-op assessment and Post-op assessment (post anesthesia care unit (PACU), Phase II-prior to discharge Phone calls after discharge Follow-up assessment in surgeon's office Swift path / KOOS JR surveys Pain Management Regimen pre-op physical therapy teaching post-op multimodal pain regimen

Official Title
-----------------
Opioid-Free Accelerated Recovery Total Knee Arthroplasty

Conditions
-----------------
Arthropathy of Knee Joint

Intervention / Treatment
-----------------
* Other: opioids


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Surgeries to be performed at hospital Surgeries to be performed at surgery center Ability to read and understand English Primary care clearance for patients diagnosed with high blood pressure Exclusion Criteria: Disease states, patient conditions to exclude: Schizophrenia Bipolar Disease Dementia Known allergies to local anesthetics Previous burn to affected extremity BMI > 40 Nonoptimized anemia Albumin less than 3.5 A1C > 8.0
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: opioids|dosage frequency and duration|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |