Knee Positioning After Total Knee Replacement
30 juli 2026 uppdaterad av: Brett Hayden, Icahn School of Medicine at Mount Sinai
The Effects of Postoperative Positioning in Knee Flexion Versus Usual Care After Total Knee Arthroplasty: A Randomized Controlled 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
150
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Brocha Stern
- Telefonnummer: 212-659-9650
- E-post: brocha.stern@mountsinai.org
Studieorter
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New York
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New York, New York, Förenta staterna, 10029
- Mount Sinai Health System
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Kontakt:
- Brocha Stern
- Telefonnummer: (212) 659-9650
- E-post: brocha.stern@mountsinai.org
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Knee Flexion
Participants in this arm will receive the knee flexion intervention.
|
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.
|
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Aktiv komparator: Usual 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.
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Knee Passive Total Arc of Motion
Tidsram: At 6 weeks after surgery
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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.
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At 6 weeks after surgery
|
|
Maximum Pain Intensity
Tidsram: 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.
|
At 7 days after surgery
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Knee Passive Total Arc of Motion
Tidsram: 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.
|
At 2.5 weeks, 3 months, 6 months, and 12 months after surgery
|
|
Maximum Pain Intensity
Tidsram: 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.
|
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
|
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Total Opioid Consumption
Tidsram: Postoperative days 0 through 14
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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.
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Postoperative days 0 through 14
|
|
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement
Tidsram: 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.
|
At 6 weeks, 3 months, 6 months, and 12 months after surgery
|
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Veterans RAND 12-item Health Survey
Tidsram: 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.
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At 6 weeks, 3 months, 6 months, and 12 months after surgery
|
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Goodman Satisfaction Score
Tidsram: 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.
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12 months after surgery
|
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Length of Hospital Stay
Tidsram: 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.
|
Through hospital discharge, average of 1 day, up to 30 days after surgery
|
|
Percentage of Participants with an Emergency Department Visit
Tidsram: 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.
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Within 7 days, 30 days, and 90 days after surgery
|
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Percentage of Participants with a Hospital Readmission
Tidsram: 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.
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Within 30 days and 90 days after surgery
|
|
Percentage of Participants with Deep Vein Thrombosis
Tidsram: Within 30 days and 90 days after surgery
|
Percentage of participants who have deep vein thrombosis after surgery.
|
Within 30 days and 90 days after surgery
|
|
Percentage of Participants with a Pulmonary Embolism
Tidsram: 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.
|
Within 30 days and 90 days after surgery
|
|
Percentage of Participants with a Venous Thromboembolism
Tidsram: 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.
|
Within 30 days and 90 days after surgery
|
|
Percentage of Participants with a Coronary Event
Tidsram: 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.
|
Within 30 days and 90 days after surgery
|
|
Percentage of Participants with a Stroke
Tidsram: 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.
|
Within 30 days and 90 days after surgery
|
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Percentage of Participants with a Blood Transfusion
Tidsram: 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.
|
Within 30 days after surgery
|
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Percentage of Participants with a Wound Dehiscence
Tidsram: 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.
|
Within 30 days and 90 days after surgery
|
|
Percentage of Participants with a Mechanical Complication
Tidsram: 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.
|
Within 30 days and 90 days after surgery
|
|
Percentage of Participants with a Manipulation under Anesthesia
Tidsram: 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.
|
Within 12 months after surgery
|
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Percentage of Participants with a Knee Revision Surgery
Tidsram: 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.
|
Within 12 months after surgery
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Brett Hayden, MD, Icahn School of Medicine at Mount Sinai
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 september 2026
Primärt slutförande (Beräknad)
1 februari 2028
Avslutad studie (Beräknad)
1 februari 2029
Studieregistreringsdatum
Först inskickad
30 juli 2026
Först inskickad som uppfyllde QC-kriterierna
30 juli 2026
Första postat (Faktisk)
5 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
5 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
30 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Study 26-00680
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
No individual participant data is planned to be shared with other researchers.
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produkt tillverkad i och exporterad från U.S.A.
Nej
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