Opioid-free Accelerated Recovery Total Knee Arthroplasty
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|ClinicalTrials.gov Identifier: NCT03647709|
Recruitment Status : Completed
First Posted : August 27, 2018
Results First Posted : May 12, 2020
Last Update Posted : May 12, 2020
|Condition or disease||Intervention/treatment|
|Arthropathy of Knee Joint||Other: opioids|
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
- 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
- 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
|Study Type :||Observational|
|Actual Enrollment :||400 participants|
|Official Title:||Opioid-Free Accelerated Recovery Total Knee Arthroplasty|
|Actual Study Start Date :||October 1, 2018|
|Actual Primary Completion Date :||October 30, 2019|
|Actual Study Completion Date :||April 30, 2020|
- Other: opioids
dosage frequency and duration
- Number of Patients With Total Knee Replacement Performed Without Opioids Through 12 Weeks Postoperative [ Time Frame: 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 [ Time Frame: 12 weeks ]The total number of opioid tablets taken by patient after total knee arthroplasty performed through 12 weeks postoperative
- Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Postoperative 12 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03647709
|United States, New York|
|St Elizabeth Medical Center|
|Utica, New York, United States, 13501|
|Principal Investigator:||Andrew B Wickline, MD||St Elizabeth Medical Center|