Knee Positioning After Total Knee Replacement
ConditionKnee Arthroplasty
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIcahn School of Medicine at Mount Sinai
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Knee Flexion
Other interventionParticipants 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.
Standard Care
Procedure/SurgeryParticipants 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.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Knee FlexionExperimental treatment 1 intervention
Group B: Usual CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Knee Passive Total Arc of Motion
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.
Time frame
At 6 weeks after surgery2
Maximum Pain Intensity
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.
Time frame
At 7 days after surgerySecondary outcomes
1
Knee Passive Total Arc of Motion
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.
Time frame
At 2.5 weeks, 3 months, 6 months, and 12 months after surgery2
Maximum Pain Intensity
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.
Time frame
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 surgery3
Total Opioid Consumption
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.
Time frame
Postoperative days 0 through 144
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement
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.
Time frame
At 6 weeks, 3 months, 6 months, and 12 months after surgerySponsors and contacts
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Source ClinicalTrials.gov
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