Opioid-free Accelerated Recovery Total Knee Arthroplasty

Arthropathy of Knee Joint Clinical Trial

Official title:

Opioid-Free Accelerated Recovery Total Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03647709
• Other study ID #: qllS
• Status: Completed
• Start date: October 1, 2018
• Est. completion date: April 30, 2020

Study information

• Verified date: May 2020
• Source: St. Elizabeth Medical Center, Utica, NY
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: April 30, 2020
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Arthropathy of Knee Joint
• Joint Diseases

Intervention

Other:
• opioids
dosage frequency and duration

Locations

Country	Name	City	State
United States	St Elizabeth Medical Center	Utica	New York

Sponsors (2)

Lead Sponsor	Collaborator
St. Elizabeth Medical Center, Utica, NY	Halyard Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	12 weeks
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	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.	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.	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.	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.	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.	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.	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.	Postoperative 12 weeks