Trial Outcomes & Findings for Opioid-free Accelerated Recovery Total Knee Arthroplasty (NCT NCT03647709)

NCT ID: NCT03647709

Last Updated: 2020-05-12

Results Overview

Using a combination of patient education, optimized pre-operative and post-operative pain protocols and optimized recovery protocols

• Recruitment status: COMPLETED
• Target enrollment: 400 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2020-05-12

Participant Flow

All patients to have total knee arthroplasty. All patients have optimized BMI, hemoglobin, albumin, glucose control-A1C and blood pressure. All patients enrolled in educational program. All patients have pre-op physical therapy teaching.

Participant milestones

Measure	Total Knee Arthoplasty All study patients received the same surgical procedure by the same surgeon, using same implants, approach, pre and post-optimization and a simplified pain protocol at a single hospital or surgery center. The number of opioid tablets taken by each patient was calculated from electronic medical record chart review, post anesthesia care unit, nursing care prior to discharge, phone calls after discharge and follow-up in surgeon's office.
Overall Study STARTED	400
Overall Study COMPLETED	386
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Measure	Total Knee Arthoplasty All study patients received the same surgical procedure by the same surgeon, using same implants, approach, pre and post-optimization and a simplified pain protocol at a single hospital or surgery center. The number of opioid tablets taken by each patient was calculated from electronic medical record chart review, post anesthesia care unit, nursing care prior to discharge, phone calls after discharge and follow-up in surgeon's office.
Overall Study Lost to Follow-up	5
Overall Study Physician Decision	6
Overall Study Withdrawal by Subject	3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Total Knee Arthroplasty n=386 Participants Number of patients that had total knee arthroplasty after meeting study inclusion criteria
Age, Continuous	69 years n=386 Participants
Sex: Female, Male Female	226 Participants n=386 Participants
Sex: Female, Male Male	160 Participants n=386 Participants
BMI	31.6 kg/m² STANDARD_DEVIATION 5.2 • n=386 Participants
ASA I	8 participants n=386 Participants • Number analyzed different from overall participants due to missing data from anesthesiologist record prior to surgery.
ASA II	173 participants n=386 Participants • Number analyzed different from overall participants due to missing data from anesthesiologist record prior to surgery.
ASA III	200 participants n=386 Participants • Number analyzed different from overall participants due to missing data from anesthesiologist record prior to surgery.
ASA IV	5 participants n=386 Participants • Number analyzed different from overall participants due to missing data from anesthesiologist record prior to surgery.

PRIMARY outcome

Timeframe: 12 weeks

Population: Number of patents that took no opioids after total knee arthroplasty 12 weeks post surgery

Using a combination of patient education, optimized pre-operative and post-operative pain protocols and optimized recovery protocols

Outcome measures

Measure	Total Knee Arthoplasty n=386 Participants All study patients received the same surgical procedure by the same surgeon, using same implants, approach, pre and post-optimization and a simplified pain protocol at a single hospital or surgery center. The number of opioid tablets taken by each patient was calculated from electronic medical record chart review, post anesthesia care unit, nursing care prior to discharge, phone calls after discharge and follow-up in surgeon's office.	Opiates and Physical Therapy Adherence physical therapy adherence and non-adherence Post surgery Days 10-14, week 3 post surgery, 6 week post surgery and 12 week post surgery
Number of Patients With Total Knee Replacement Performed Without Opioids Through 12 Weeks Postoperative	73 Participants	—

PRIMARY outcome

Timeframe: 12 weeks

Population: Number of Participants Stratified by Total Quantity of Opioid Tablets Taken Post Total Knee Replacement

The total number of opioid tablets taken by patient after total knee arthroplasty performed through 12 weeks postoperative

Outcome measures

Measure	Total Knee Arthoplasty n=385 Participants All study patients received the same surgical procedure by the same surgeon, using same implants, approach, pre and post-optimization and a simplified pain protocol at a single hospital or surgery center. The number of opioid tablets taken by each patient was calculated from electronic medical record chart review, post anesthesia care unit, nursing care prior to discharge, phone calls after discharge and follow-up in surgeon's office.	Opiates and Physical Therapy Adherence physical therapy adherence and non-adherence Post surgery Days 10-14, week 3 post surgery, 6 week post surgery and 12 week post surgery
Number of Patients With Total Knee Arthroplasty Performed With Opiate Drugs Through 12 Weeks Postoperative no opioids	72 Participants	—
Number of Patients With Total Knee Arthroplasty Performed With Opiate Drugs Through 12 Weeks Postoperative 1-5 tablets	159 Participants	—
Number of Patients With Total Knee Arthroplasty Performed With Opiate Drugs Through 12 Weeks Postoperative 6-10 tablets	101 Participants	—
Number of Patients With Total Knee Arthroplasty Performed With Opiate Drugs Through 12 Weeks Postoperative >10 tablets	53 Participants	—

SECONDARY outcome

Timeframe: postoperative days 1,2,3,postoperative day 10-14, 3 weeks post surgery, 6 weeks post surgery and 12 weeks post surgery

Population: 386 patients analyzed through 6 weeks; 340 patients analyzed at 12 weeks only.

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.

Outcome measures

Measure	Total Knee Arthoplasty n=386 Participants All study patients received the same surgical procedure by the same surgeon, using same implants, approach, pre and post-optimization and a simplified pain protocol at a single hospital or surgery center. The number of opioid tablets taken by each patient was calculated from electronic medical record chart review, post anesthesia care unit, nursing care prior to discharge, phone calls after discharge and follow-up in surgeon's office.	Opiates and Physical Therapy Adherence physical therapy adherence and non-adherence Post surgery Days 10-14, week 3 post surgery, 6 week post surgery and 12 week post surgery
Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity Postoperative Days 10-14 - Best with Activity	2.0 score on a scale Standard Deviation 1.9	—
Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity Postoperative Day 1 - Best with Rest	1.0 score on a scale Standard Deviation 1.8	—
Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity Postoperative Day 1 - Worst with Rest	2.4 score on a scale Standard Deviation 2.3	—
Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity Postoperative Day 1 - Best with Activity	2.9 score on a scale Standard Deviation 2.2	—
Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity Postoperative Day 1 - Worst with Activity	4.6 score on a scale Standard Deviation 2.3	—
Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity Postoperative Day 2 - Best at Rest	1.8 score on a scale Standard Deviation 2.0	—
Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity Postoperative Day 2 - Worst at Rest	3.4 score on a scale Standard Deviation 2.3	—
Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity Postoperative Day 2 - Best with Activity	4.2 score on a scale Standard Deviation 2.0	—
Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity Postoperative Day 2 - Worst with Activity	5.9 score on a scale Standard Deviation 1.9	—
Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity Postoperative Day 3 - Best at Rest	1.0 score on a scale Standard Deviation 1.6	—
Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity Postoperative Day 3 - Worst at Rest	2.4 score on a scale Standard Deviation 2.1	—
Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity Postoperative Day 3 - Best with Activity	3.3 score on a scale Standard Deviation 2.1	—
Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity Postoperative Day 3 - Worst with Activity	5.0 score on a scale Standard Deviation 2.0	—
Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity Postoperative Days 10-14 - Best at Rest	0.5 score on a scale Standard Deviation 1.2	—
Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity Postoperative Days 10-14 - Worst at Rest	2.1 score on a scale Standard Deviation 2.0	—
Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity Postoperative Days 10-14 Worst with Activity	4.0 score on a scale Standard Deviation 2.1	—
Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity Postoperative Week 3 - Best at Rest	0.3 score on a scale Standard Deviation 0.8	—
Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity Postoperative Week 3 - Worst at Rest	1.5 score on a scale Standard Deviation 1.9	—
Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity Postoperative Week 3- Best with Activity	1.3 score on a scale Standard Deviation 1.6	—
Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity Postoperative Week 3 - Worst with Activity	3.1 score on a scale Standard Deviation 2.1	—
Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity Postoperative Week 6 - Best at Rest	0.1 score on a scale Standard Deviation 0.6	—
Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity Postoperative Week 6 - Worst at Rest	0.7 score on a scale Standard Deviation 1.5	—
Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity Postoperative Week 6 - Best with Activity	0.5 score on a scale Standard Deviation 1.2	—
Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity Postoperative Week 6 - Worst with Activity	1.9 score on a scale Standard Deviation 2.0	—
Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity Postoperative Week 12 - Best at Rest	0.0 score on a scale Standard Deviation 0.2	—
Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity Postoperative Week 12 - Worst at Rest	0.2 score on a scale Standard Deviation 0.7	—
Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity Postoperative Week 12 - Best with Activity	0.0 score on a scale Standard Deviation 0.3	—
Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity Postoperative Week 12 - Worst with Activity	0.5 score on a scale Standard Deviation 1.2	—

SECONDARY outcome

Timeframe: Baseline (preoperative); 6 weeks post surgery; 12 weeks post surgery

Population: 311 patients reported KOOS JR scores at baseline which was prior to surgery. At 6 weeks 379 patients reported scores. At 12 weeks 341 patients reported scores.

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.

Outcome measures

Measure	Total Knee Arthoplasty n=379 Participants All study patients received the same surgical procedure by the same surgeon, using same implants, approach, pre and post-optimization and a simplified pain protocol at a single hospital or surgery center. The number of opioid tablets taken by each patient was calculated from electronic medical record chart review, post anesthesia care unit, nursing care prior to discharge, phone calls after discharge and follow-up in surgeon's office.	Opiates and Physical Therapy Adherence physical therapy adherence and non-adherence Post surgery Days 10-14, week 3 post surgery, 6 week post surgery and 12 week post surgery
Knee Injury and Osteoarthritis Outcome Score Short Form (KOOS JR) Baseline prior to surgery	53.1 score on a scale Standard Deviation 11.9	—
Knee Injury and Osteoarthritis Outcome Score Short Form (KOOS JR) Postoperative 6 Week	71.8 score on a scale Standard Deviation 11.8	—
Knee Injury and Osteoarthritis Outcome Score Short Form (KOOS JR) Postoperative 12 Week	90.0 score on a scale Standard Deviation 8.2	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Total Knee Arthoplasty n=386 Participants All study patients received the same surgical procedure by the same surgeon, using same implants, approach, pre and post-optimization and a simplified pain protocol at a single hospital or surgery center. The number of opioid tablets taken by each patient was calculated from electronic medical record chart review, post anesthesia care unit, nursing care prior to discharge, phone calls after discharge and follow-up in surgeon's office.	Opiates and Physical Therapy Adherence physical therapy adherence and non-adherence Post surgery Days 10-14, week 3 post surgery, 6 week post surgery and 12 week post surgery
Number of Participants Using Swift Path Educational Tool as Outpatients for Total Joint Replacement	386 Participants	—

SECONDARY outcome

Timeframe: Postop Days10-14

Population: Physical therapy adherence for patients not taking opioids and taking opioids at 10-14 day follow-up visit

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.

Outcome measures

Measure	Total Knee Arthoplasty n=269 Participants All study patients received the same surgical procedure by the same surgeon, using same implants, approach, pre and post-optimization and a simplified pain protocol at a single hospital or surgery center. The number of opioid tablets taken by each patient was calculated from electronic medical record chart review, post anesthesia care unit, nursing care prior to discharge, phone calls after discharge and follow-up in surgeon's office.	Opiates and Physical Therapy Adherence n=117 Participants physical therapy adherence and non-adherence Post surgery Days 10-14, week 3 post surgery, 6 week post surgery and 12 week post surgery
Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Days 10-14 PT Adherence	193 Participants	64 Participants
Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Days 10-14 PT Non-adherence	76 Participants	53 Participants

SECONDARY outcome

Timeframe: postoperative 3 weeks

Population: Physical therapy adherence for patients not taking opioids and taking opioids at 3 week follow-up visit

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.

Outcome measures

Measure	Total Knee Arthoplasty n=349 Participants All study patients received the same surgical procedure by the same surgeon, using same implants, approach, pre and post-optimization and a simplified pain protocol at a single hospital or surgery center. The number of opioid tablets taken by each patient was calculated from electronic medical record chart review, post anesthesia care unit, nursing care prior to discharge, phone calls after discharge and follow-up in surgeon's office.	Opiates and Physical Therapy Adherence n=35 Participants physical therapy adherence and non-adherence Post surgery Days 10-14, week 3 post surgery, 6 week post surgery and 12 week post surgery
Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Week 3 PT Adherence	290 Participants	28 Participants
Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Week 3 PT Non-adherence	59 Participants	7 Participants

SECONDARY outcome

Timeframe: Postoperative 6 weeks

Population: Physical therapy adherence for patients not taking opioids and taking opioids at 6 week follow-up visit

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.

Outcome measures

Measure	Total Knee Arthoplasty n=373 Participants All study patients received the same surgical procedure by the same surgeon, using same implants, approach, pre and post-optimization and a simplified pain protocol at a single hospital or surgery center. The number of opioid tablets taken by each patient was calculated from electronic medical record chart review, post anesthesia care unit, nursing care prior to discharge, phone calls after discharge and follow-up in surgeon's office.	Opiates and Physical Therapy Adherence n=12 Participants physical therapy adherence and non-adherence Post surgery Days 10-14, week 3 post surgery, 6 week post surgery and 12 week post surgery
Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Week 6 PT Adherence	361 Participants	10 Participants
Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Week 6 PT Non-adherence	12 Participants	2 Participants

SECONDARY outcome

Timeframe: Postoperative 12 weeks

Population: Physical therapy adherence for patients not taking opioids and taking opioids at 12 week follow-up visit

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.

Outcome measures

Measure	Total Knee Arthoplasty n=335 Participants All study patients received the same surgical procedure by the same surgeon, using same implants, approach, pre and post-optimization and a simplified pain protocol at a single hospital or surgery center. The number of opioid tablets taken by each patient was calculated from electronic medical record chart review, post anesthesia care unit, nursing care prior to discharge, phone calls after discharge and follow-up in surgeon's office.	Opiates and Physical Therapy Adherence n=2 Participants physical therapy adherence and non-adherence Post surgery Days 10-14, week 3 post surgery, 6 week post surgery and 12 week post surgery
Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Post Week 12 PT Adherence	297 Participants	2 Participants
Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Post Week 12 PT Non-adherence	38 Participants	0 Participants

Adverse Events

Total Knee Arthoplasty

Serious events: 4 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Measure	Total Knee Arthoplasty n=386 participants at risk All study patients received the same surgical procedure by the same surgeon, using same implants, approach, pre and post-optimization and a simplified pain protocol at a single hospital or surgery center. The number of opioid tablets taken by each patient was calculated from electronic medical record chart review, post anesthesia care unit, nursing care prior to discharge, phone calls after discharge and follow-up in surgeon's office.
Infections and infestations infection	0.26% 1/386 • Number of events 1 • 12 weeks Adverse events were events that occurred from day of surgery through 12 week post-surgery.
Musculoskeletal and connective tissue disorders right quadricep repair	0.26% 1/386 • Number of events 1 • 12 weeks Adverse events were events that occurred from day of surgery through 12 week post-surgery.
Gastrointestinal disorders bowel obstruction	0.26% 1/386 • Number of events 1 • 12 weeks Adverse events were events that occurred from day of surgery through 12 week post-surgery.
Respiratory, thoracic and mediastinal disorders pneumonia	0.26% 1/386 • Number of events 1 • 12 weeks Adverse events were events that occurred from day of surgery through 12 week post-surgery.

Other adverse events

Measure	Total Knee Arthoplasty n=386 participants at risk All study patients received the same surgical procedure by the same surgeon, using same implants, approach, pre and post-optimization and a simplified pain protocol at a single hospital or surgery center. The number of opioid tablets taken by each patient was calculated from electronic medical record chart review, post anesthesia care unit, nursing care prior to discharge, phone calls after discharge and follow-up in surgeon's office.
Skin and subcutaneous tissue disorders bleeding	0.52% 2/386 • Number of events 2 • 12 weeks Adverse events were events that occurred from day of surgery through 12 week post-surgery.
Social circumstances fall	3.6% 14/386 • Number of events 14 • 12 weeks Adverse events were events that occurred from day of surgery through 12 week post-surgery.
Surgical and medical procedures motor weakness	2.1% 8/386 • Number of events 8 • 12 weeks Adverse events were events that occurred from day of surgery through 12 week post-surgery.
Nervous system disorders paresthesia	0.26% 1/386 • Number of events 1 • 12 weeks Adverse events were events that occurred from day of surgery through 12 week post-surgery.
Surgical and medical procedures uncontrolled pain	1.0% 4/386 • Number of events 4 • 12 weeks Adverse events were events that occurred from day of surgery through 12 week post-surgery.
Surgical and medical procedures early pain ball catheter removal by patient	2.3% 9/386 • Number of events 9 • 12 weeks Adverse events were events that occurred from day of surgery through 12 week post-surgery.
Surgical and medical procedures inadvertent pain ball catheter removal	0.78% 3/386 • Number of events 3 • 12 weeks Adverse events were events that occurred from day of surgery through 12 week post-surgery.
Nervous system disorders persistent numbness	0.52% 2/386 • Number of events 2 • 12 weeks Adverse events were events that occurred from day of surgery through 12 week post-surgery.
Musculoskeletal and connective tissue disorders manipulation of knee joint	2.3% 9/386 • Number of events 9 • 12 weeks Adverse events were events that occurred from day of surgery through 12 week post-surgery.

Additional Information

Dr Andrew Wickline

St Elizabeth Medical Center

Phone: 315-735-4496

Email: awickline23@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place