Opioid-free Accelerated Recovery Total Knee Arthroplasty

Opioid-Free Accelerated Recovery Total Knee Arthroplasty

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.

Study Overview

• Status: Completed
• Conditions: Arthropathy of Knee Joint
• Intervention / Treatment: Other: opioids

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

• Study Type: Observational
• Enrollment (Actual): 400

Contacts and Locations

Study Locations

• United States
  • New York
    • Utica, New York, United States, 13501
      • St Elizabeth Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

A Partial and total knee arthroplasty Unilateral only

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

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

Collaborators and Investigators

• Sponsor: St. Elizabeth Medical Center, Utica, NY
• Collaborators: Halyard Health
• Investigators: Principal Investigator: Andrew B Wickline, MD, St Elizabeth Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): October 30, 2019
• Study Completion (Actual): April 30, 2020

Study Registration Dates

• First Submitted: August 9, 2018
• First Submitted That Met QC Criteria: August 23, 2018
• First Posted (Actual): August 27, 2018

Study Record Updates

• Last Update Posted (Actual): May 12, 2020
• Last Update Submitted That Met QC Criteria: May 11, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Narcotics; Analgesics, Opioid
• Other Study ID Numbers: qllS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No