Knee Positioning After Total Knee Replacement
30 lipca 2026 zaktualizowane przez: 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.
Przegląd badań
Status
Jeszcze nie rekrutacja
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Interwencyjne
Zapisy (Szacowany)
150
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Brocha Stern
- Numer telefonu: 212-659-9650
- E-mail: brocha.stern@mountsinai.org
Lokalizacje studiów
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New York
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New York, New York, Stany Zjednoczone, 10029
- Mount Sinai Health System
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Kontakt:
- Brocha Stern
- Numer telefonu: (212) 659-9650
- E-mail: brocha.stern@mountsinai.org
-
-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Nie
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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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Aktywny 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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Knee Passive Total Arc of Motion
Ramy czasowe: 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
Ramy czasowe: At 7 days after surgery
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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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Knee Passive Total Arc of Motion
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
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Knee Injury and Osteoarthritis Outcome Score for Joint Replacement
Ramy czasowe: At 6 weeks, 3 months, 6 months, and 12 months after surgery
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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.
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At 6 weeks, 3 months, 6 months, and 12 months after surgery
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Veterans RAND 12-item Health Survey
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.
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Through hospital discharge, average of 1 day, up to 30 days after surgery
|
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Percentage of Participants with an Emergency Department Visit
Ramy czasowe: Within 7 days, 30 days, and 90 days after surgery
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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
Ramy czasowe: Within 30 days and 90 days after surgery
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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
|
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Percentage of Participants with Deep Vein Thrombosis
Ramy czasowe: Within 30 days and 90 days after surgery
|
Percentage of participants who have deep vein thrombosis after surgery.
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Within 30 days and 90 days after surgery
|
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Percentage of Participants with a Pulmonary Embolism
Ramy czasowe: 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.
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Within 30 days and 90 days after surgery
|
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Percentage of Participants with a Venous Thromboembolism
Ramy czasowe: 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
|
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Percentage of Participants with a Coronary Event
Ramy czasowe: 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.
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Within 30 days and 90 days after surgery
|
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Percentage of Participants with a Stroke
Ramy czasowe: 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.
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Within 30 days and 90 days after surgery
|
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Percentage of Participants with a Blood Transfusion
Ramy czasowe: Within 30 days after surgery
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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.
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Within 30 days after surgery
|
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Percentage of Participants with a Wound Dehiscence
Ramy czasowe: 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
|
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Percentage of Participants with a Mechanical Complication
Ramy czasowe: 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.
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Within 30 days and 90 days after surgery
|
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Percentage of Participants with a Manipulation under Anesthesia
Ramy czasowe: Within 12 months after surgery
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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.
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Within 12 months after surgery
|
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Percentage of Participants with a Knee Revision Surgery
Ramy czasowe: 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.
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Within 12 months after surgery
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Śledczy
- Główny śledczy: Brett Hayden, MD, Icahn School of Medicine at Mount Sinai
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
1 września 2026
Zakończenie podstawowe (Szacowany)
1 lutego 2028
Ukończenie studiów (Szacowany)
1 lutego 2029
Daty rejestracji na studia
Pierwszy przesłany
30 lipca 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
30 lipca 2026
Pierwszy wysłany (Rzeczywisty)
5 sierpnia 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
5 sierpnia 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
30 lipca 2026
Ostatnia weryfikacja
1 lipca 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- Study 26-00680
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Opis planu IPD
No individual participant data is planned to be shared with other researchers.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
produkt wyprodukowany i wyeksportowany z USA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .