Knee Positioning After Total Knee Replacement
30. Juli 2026 aktualisiert von: 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.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Geschätzt)
150
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Brocha Stern
- Telefonnummer: 212-659-9650
- E-Mail: brocha.stern@mountsinai.org
Studienorte
-
-
New York
-
New York, New York, Vereinigte Staaten, 10029
- Mount Sinai Health System
-
Kontakt:
- Brocha Stern
- Telefonnummer: (212) 659-9650
- E-Mail: brocha.stern@mountsinai.org
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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.
|
|
Aktiver 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Knee Passive Total Arc of Motion
Zeitfenster: 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.
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At 6 weeks after surgery
|
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Maximum Pain Intensity
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Knee Passive Total Arc of Motion
Zeitfenster: 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
Zeitfenster: 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
|
|
Total Opioid Consumption
Zeitfenster: 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.
|
Postoperative days 0 through 14
|
|
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement
Zeitfenster: 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
|
|
Veterans RAND 12-item Health Survey
Zeitfenster: 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.
|
At 6 weeks, 3 months, 6 months, and 12 months after surgery
|
|
Goodman Satisfaction Score
Zeitfenster: 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.
|
12 months after surgery
|
|
Length of Hospital Stay
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
|
Within 30 days and 90 days after surgery
|
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Percentage of Participants with Deep Vein Thrombosis
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
|
Percentage of Participants with a Wound Dehiscence
Zeitfenster: 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
Zeitfenster: 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
|
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Percentage of Participants with a Manipulation under Anesthesia
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Ermittler
- Hauptermittler: Brett Hayden, MD, Icahn School of Medicine at Mount Sinai
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
1. September 2026
Primärer Abschluss (Geschätzt)
1. Februar 2028
Studienabschluss (Geschätzt)
1. Februar 2029
Studienanmeldedaten
Zuerst eingereicht
30. Juli 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
30. Juli 2026
Zuerst gepostet (Tatsächlich)
5. August 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
5. August 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
30. Juli 2026
Zuletzt verifiziert
1. Juli 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- Study 26-00680
Plan für individuelle Teilnehmerdaten (IPD)
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NEIN
Beschreibung des IPD-Plans
No individual participant data is planned to be shared with other researchers.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Produkt, das in den USA hergestellt und aus den USA exportiert wird
Nein
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