Knee Arthroplasty
Conditions
Keywords
Knee Flexion
Brief summary
Many total knee replacements are performed each year, but there is no clear recommendation regarding knee positioning following this surgery. While the surgical knee is usually positioned in a straight position immediately after surgery, there may be benefits of positioning it in a partially bent position. A trial will compare the outcomes of two groups of patients: a) those whose knees are positioned in a partially bent position for a few hours after surgery and b) those who receive usual care where the knee is most likely positioned in a straight position. The investigators are looking to see whether knee motion and pain differ for patients in the two groups.
Detailed description
This parallel two-arm randomized controlled trial will compare outcomes for knee flexion versus usual care in the immediate postoperative period after total knee arthroplasty. Patients who are scheduled for elective primary unilateral total knee arthroplasty will be recruited from an academic health system, screened for inclusion/exclusion criteria, and enrolled. The experimental group will have their surgical knee positioned in approximately 60° of flexion for 2-4 hours after surgery. The control group will receive usual care, where the knee will generally be positioned in extension. Other than the study intervention, both groups will receive standard perioperative, intraoperative, and postoperative care as determined by their treating clinical team. The co-primary endpoints are 6-week knee passive total arc of motion and 7-day maximum pain intensity. Secondary outcomes will be assessed throughout the 12 months after surgery and will include knee motion and pain intensity at other time points; oral opioid consumption; patient-reported questionnaires of knee health, quality of life, and satisfaction; healthcare utilization; and complications. Adverse events will also be monitored for the 12 months after surgery. Outcomes will be assessed via phone or electronic surveys; routine care visits at 2.5 weeks, 6 weeks, 3 months, 6 months, and 12 months after surgery; and chart review.
Interventions
OTHERKnee Flexion
Participants will receive knee flexion postoperatively following primary total knee arthroplasty. The surgical knee will positioned at approximately 60° flexion using an abduction pillow as a jig underneath the knee during the immediate postoperative recovery period. Positioning will occur following surgery while the participant is still in the operating room. This is a soft construct and a noninvasive intervention. A goniometer will be used to approximate 60° of flexion as closely as possible. It is expected that the knee will be positioned for 2-4 postoperative hours until a physical therapist comes to mobilize the patient. However, the duration may vary because of the pragmatic context. There is no minimum or maximum positioning time that would make the intervention duration ineligible.
PROCEDUREStandard Care
Participants in this arm will receive usual care. No specific attention will be placed to knee positioning in the immediate period after surgery. However, the current usual practice in the health system is that the knee is positioned in extension.
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Masking description
Participant arm assignment will be concealed from the surgeon who will leave the operating room before the knee is positioned. The surgeon will also be the assessor of the primary 6-week knee total arc of motion endpoint. The patient and investigators assessing other endpoints will not be masked to the arm.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * Males and females; Age \>18 years * Scheduled for elective primary unilateral total knee arthroplasty * The planned arthroplasty is secondary to physician-confirmed diagnosis of knee osteoarthritis * English- or Spanish-speaking
Exclusion criteria
* Patients with a history of chronic opioid use or chronic pain disorders * Patients with a history of bleeding disorders/coagulopathy * Patients receiving a total knee replacement secondary to trauma, avascular necrosis, tumor, or Charcot arthropathy * Patients scheduled to undergo multiple procedures simultaneously * Patients with cognitive impairment or inability to consent independently
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knee Passive Total Arc of Motion | At 6 weeks after surgery | Passive total arc of motion will be evaluated through goniometric assessment of maximal passive knee flexion and passive knee extension. Both measures will be recorded, but a single endpoint will be derived by subtracting available extension from available flexion. |
| Maximum Pain Intensity | At 7 days after surgery | Pain intensity will be evaluated via the patient-reported Numeric Rating Scale (NRS) for pain. The rating is from 0 to 10, with a higher score indicating worse pain. The worst (i.e., maximum) pain intensity will be used. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knee Passive Total Arc of Motion | At 2.5 weeks, 3 months, 6 months, and 12 months after surgery | Passive total arc of motion will be evaluated through goniometric assessment of maximal passive knee flexion and passive knee extension. Both measures will be recorded, but a single endpoint will be derived by subtracting available extension from available flexion. |
| Maximum Pain Intensity | At 0 days, 1 day, 2 days, 3 days, 10 days, 14 days, 2.5 weeks, 6 weeks, 3 months, 6 months, and 12 months after surgery | Pain intensity will be evaluated via the patient-reported Numeric Rating Scale (NRS) for pain. The rating is from 0 to 10, with a higher score indicating worse pain. The worst (i.e., maximum) pain intensity will be used. |
| Total Opioid Consumption | Postoperative days 0 through 14 | Consumption of opioids standardized in oral morphine milligram equivalents based on medical records for in-hospital administration, prescriptions, and patient report for at-home consumption. Consumption will be summed across days, with higher numbers indicating greater opioid consumption. |
| Knee Injury and Osteoarthritis Outcome Score for Joint Replacement | At 6 weeks, 3 months, 6 months, and 12 months after surgery | The Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR) is a patient-reported measure of knee health (i.e., pain and function). Scores range from 0 to 100, with higher scores indicating better health. |
| Veterans RAND 12-item Health Survey | At 6 weeks, 3 months, 6 months, and 12 months after surgery | The Veterans RAND 12-item Health Survey (VR-12) is a patient-reported measure of global physical and mental health. It provides a physical component summary score and a mental component summary score. These are T-scores with a mean of 50, and higher scores indicate better health. |
| Goodman Satisfaction Score | 12 months after surgery | The Goodman Satisfaction Score assesses patient satisfaction with total hip or knee arthroplasty outcomes. Scores range from 0 to 100, with higher scores indicating greater satisfaction. |
| Length of Hospital Stay | Through hospital discharge, average of 1 day, up to 30 days after surgery | Number of days the patient stays in the hospital after the index surgery. This information will be extracted from the medical record. |
| Percentage of Participants with an Emergency Department Visit | Within 7 days, 30 days, and 90 days after surgery | Percentage of participants with an all-cause emergency department visit after surgery. This information will be extracted from the medical record, with supplementation by participant queries during the postoperative visit after the respective timepoint. |
| Percentage of Participants with a Hospital Readmission | Within 30 days and 90 days after surgery | Percentage of participants with an all-cause hospital readmission after surgery. This information will be extracted from the medical record, with supplementation by participant queries during the postoperative visit after the respective timepoint. |
| Percentage of Participants with Deep Vein Thrombosis | Within 30 days and 90 days after surgery | Percentage of participants who have deep vein thrombosis after surgery. |
| Percentage of Participants with a Pulmonary Embolism | Within 30 days and 90 days after surgery | Percentage of participants who have a pulmonary embolism after surgery. This information will be extracted from the medical record, with supplementation by participant queries during the postoperative visit after the respective timepoint. |
| Percentage of Participants with a Venous Thromboembolism | Within 30 days and 90 days after surgery | Percentage of participants who have a venous thromboembolism after surgery. This information will be extracted from the medical record, with supplementation by participant queries during the postoperative visit after the respective timepoint. |
| Percentage of Participants with a Coronary Event | Within 30 days and 90 days after surgery | Percentage of participants who have a myocardial infarction or other coronary event after surgery. This information will be extracted from the medical record, with supplementation by participant queries during the postoperative visit after the respective timepoint. |
| Percentage of Participants with a Stroke | Within 30 days and 90 days after surgery | Percentage of participants who have a stroke after surgery. This information will be extracted from the medical record, with supplementation by participant queries during the postoperative visit after the respective timepoint. |
| Percentage of Participants with a Blood Transfusion | Within 30 days after surgery | Percentage of participants who receive a blood transfusion after surgery. This information will be extracted from the medical record, with supplementation by participant queries during the postoperative visit after the respective timepoint. |
| Percentage of Participants with a Wound Dehiscence | Within 30 days and 90 days after surgery | Percentage of participants who have a wound dehiscence after surgery. This information will be extracted from the medical record, with supplementation by participant queries during the postoperative visit after the respective timepoint. |
| Percentage of Participants with a Mechanical Complication | Within 30 days and 90 days after surgery | Percentage of participants who have a mechanical complication after surgery. This information will be extracted from the medical record, with supplementation by participant queries during the postoperative visit after the respective timepoint. |
| Percentage of Participants with a Manipulation under Anesthesia | Within 12 months after surgery | Percentage of participants who undergo a manipulation under anesthesia after surgery. This information will be extracted from the medical record, with supplementation by participant queries during the postoperative visit after the respective timepoint. |
| Percentage of Participants with a Knee Revision Surgery | Within 12 months after surgery | Percentage of participants who undergo a knee revision surgery after the index surgery. This information will be extracted from the medical record, with supplementation by participant queries during the postoperative visit after the respective timepoint. |
Countries
United States
Contacts
CONTACTBrocha Stern
PRINCIPAL_INVESTIGATORBrett Hayden, MD
Icahn School of Medicine at Mount Sinai
Outcome results
None listed