Opioid-free Accelerated Recovery Total Knee Arthroplasty

Completed

Conditions: Arthropathy of Knee Joint

Registration Number: NCT03647709

Lead Sponsor: St. Elizabeth Medical Center, Utica, NY

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:

1. Pre-op Optimization

* All patients enroll in education program

* All patients have optimized BMI, hemoglobin, albumin, glucose control-A1C, and blood pressure

2. Total Joint Procedure

* Tourniquet-free cemented total knee arthroplasty is performed with intra-articular block

3. 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

4. Pain Management Regimen

* pre-op physical therapy teaching

* post-op multimodal pain regimen

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 400

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Patients With Total Knee Replacement Performed Without Opioids Through 12 Weeks Postoperative	12 weeks	Using a combination of patient education, optimized pre-operative and post-operative pain protocols and optimized recovery protocols
Number of Patients With Total Knee Arthroplasty Performed With Opiate Drugs Through 12 Weeks Postoperative	12 weeks	The total number of opioid tablets taken by patient after total knee arthroplasty performed through 12 weeks postoperative

Secondary Outcome Measures

Name	Time	Method
Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity	postoperative days 1,2,3,postoperative day 10-14, 3 weeks post surgery, 6 weeks post surgery and 12 weeks post surgery	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.
Knee Injury and Osteoarthritis Outcome Score Short Form (KOOS JR)	Baseline (preoperative); 6 weeks post surgery; 12 weeks post surgery	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.
Number of Participants Using Swift Path Educational Tool as Outpatients for Total Joint Replacement	6 weeks	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.
Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Days 10-14	Postop Days10-14	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.
Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Week 3	postoperative 3 weeks	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.
Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Week 6	Postoperative 6 weeks	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.
Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Post Week 12	Postoperative 12 weeks	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.