NCT03647709

Opioid-free Accelerated Recovery Total Knee Arthroplasty

Completed Results posted Last updated 12 May 2020

What this trial tests

trial testing opioids in Arthropathy of Knee Joint in 400 participants. Completed in 30 April 2020.

Timeline

1 October 2018

Primary endpoint
30 October 2019

30 April 2020

Quick facts

Lead sponsor	St. Elizabeth Medical Center, Utica, NY
Status	Completed
Study type	OBSERVATIONAL
Enrollment	400
Start date	1 October 2018
Primary completion	30 October 2019
Estimated completion	30 April 2020
Sites	1 location across United States

Drugs / interventions tested

• opioids — full drug profile →

Conditions studied

• Arthropathy of Knee Joint — all drugs for Arthropathy of Knee Joint →

Sponsor

St. Elizabeth Medical Center, Utica, NY

Who can join

Eligibility, any sex, with Arthropathy of Knee Joint. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Patients With Total Knee Replacement Performed Without Opioids Through 12 Weeks Postoperative Primary · 12 weeks

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

Group	Value	95% CI
Total Knee Arthoplasty	73

Number of Patients With Total Knee Arthroplasty Performed With Opiate Drugs Through 12 Weeks Postoperative Primary · 12 weeks

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

Group	Value	95% CI
Total Knee Arthoplasty	72
Total Knee Arthoplasty	159
Total Knee Arthoplasty	101
Total Knee Arthoplasty	53

Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity Secondary · 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.

Postoperative Day 1 - Best with Rest

Group	Value	95% CI
Total Knee Arthoplasty	1.0	± 1.8

Postoperative Day 1 - Worst with Rest

Group	Value	95% CI
Total Knee Arthoplasty	2.4	± 2.3

Postoperative Day 1 - Best with Activity

Group	Value	95% CI
Total Knee Arthoplasty	2.9	± 2.2

Postoperative Day 1 - Worst with Activity

Group	Value	95% CI
Total Knee Arthoplasty	4.6	± 2.3

Postoperative Day 2 - Best at Rest

Group	Value	95% CI
Total Knee Arthoplasty	1.8	± 2.0

Postoperative Day 2 - Worst at Rest

Group	Value	95% CI
Total Knee Arthoplasty	3.4	± 2.3

Postoperative Day 2 - Best with Activity

Group	Value	95% CI
Total Knee Arthoplasty	4.2	± 2.0

Postoperative Day 2 - Worst with Activity

Group	Value	95% CI
Total Knee Arthoplasty	5.9	± 1.9

Knee Injury and Osteoarthritis Outcome Score Short Form (KOOS JR) Secondary · 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

Baseline prior to surgery

Group	Value	95% CI
Total Knee Arthoplasty	53.1	± 11.9

Postoperative 6 Week

Group	Value	95% CI
Total Knee Arthoplasty	71.8	± 11.8

Postoperative 12 Week

Group	Value	95% CI
Total Knee Arthoplasty	90.0	± 8.2

Number of Participants Using Swift Path Educational Tool as Outpatients for Total Joint Replacement Secondary · 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.

Group	Value	95% CI
Total Knee Arthoplasty	386

Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Days 10-14 Secondary · 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.

Group	Value	95% CI
No Opiates and Physical Therapy Adherence	193
Opiates and Physical Therapy Adherence	64
No Opiates and Physical Therapy Adherence	76
Opiates and Physical Therapy Adherence	53

Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Week 3 Secondary · 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.

Group	Value	95% CI
No Opiates and Physical Therapy Adherence	290
Opiates and Physical Therapy Adherence	28
No Opiates and Physical Therapy Adherence	59
Opiates and Physical Therapy Adherence	7

Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Week 6 Secondary · 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.

Group	Value	95% CI
No Opiates and Physical Therapy Adherence	361
Opiates and Physical Therapy Adherence	10
No Opiates and Physical Therapy Adherence	12
Opiates and Physical Therapy Adherence	2

Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Post Week 12 Secondary · 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.

Group	Value	95% CI
No Opiates and Physical Therapy Adherence	297
Opiates and Physical Therapy Adherence	2
No Opiates and Physical Therapy Adherence	38
Opiates and Physical Therapy Adherence	0

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Total Knee Arthoplasty

Serious: 4/386 (1%)

Deaths: 0/386

Serious adverse events (4 terms)

Reaction	System	Total Knee Arthoplasty
infection	Infections and infestations	—
right quadricep repair	Musculoskeletal and connective tissue disorders	—
bowel obstruction	Gastrointestinal disorders	—
pneumonia	Respiratory, thoracic and mediastinal disorders	—

Other adverse events (9 terms — click to expand)

Reaction	System	Total Knee Arthoplasty
fall	Social circumstances	—
early pain ball catheter removal by patient	Surgical and medical procedures	—
manipulation of knee joint	Musculoskeletal and connective tissue disorders	—
motor weakness	Surgical and medical procedures	—
uncontrolled pain	Surgical and medical procedures	—
inadvertent pain ball catheter removal	Surgical and medical procedures	—
bleeding	Skin and subcutaneous tissue disorders	—
persistent numbness	Nervous system disorders	—
paresthesia	Nervous system disorders	—

Most-reported serious reactions: infection, right quadricep repair, bowel obstruction, pneumonia.

Data from ClinicalTrials.gov NCT03647709 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.