Knee Positioning After Total Knee Replacement
30. července 2026 aktualizováno: 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.
Přehled studie
Postavení
Zatím nenabíráme
Podmínky
Intervence / Léčba
Detailní popis
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 studie
Intervenční
Zápis (Odhadovaný)
150
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Brocha Stern
- Telefonní číslo: 212-659-9650
- E-mail: brocha.stern@mountsinai.org
Studijní místa
-
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New York
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New York, New York, Spojené státy, 10029
- Mount Sinai Health System
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Kontakt:
- Brocha Stern
- Telefonní číslo: (212) 659-9650
- E-mail: brocha.stern@mountsinai.org
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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.
|
|
Aktivní komparátor: 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 je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Knee Passive Total Arc of Motion
Časové okno: 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
|
|
Maximum Pain Intensity
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Knee Passive Total Arc of Motion
Časové okno: 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.
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At 2.5 weeks, 3 months, 6 months, and 12 months after surgery
|
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Maximum Pain Intensity
Časové okno: 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
Časové okno: 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.
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Postoperative days 0 through 14
|
|
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement
Časové okno: 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.
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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
Časové okno: 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
Časové okno: 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
|
|
Length of Hospital Stay
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
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Percentage of Participants with a Venous Thromboembolism
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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.
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Within 30 days after surgery
|
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Percentage of Participants with a Wound Dehiscence
Časové okno: 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
Časové okno: Within 30 days and 90 days after surgery
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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
Časové okno: 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
Časové okno: Within 12 months after surgery
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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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Vyšetřovatelé
- Vrchní vyšetřovatel: Brett Hayden, MD, Icahn School of Medicine at Mount Sinai
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
1. září 2026
Primární dokončení (Odhadovaný)
1. února 2028
Dokončení studie (Odhadovaný)
1. února 2029
Termíny zápisu do studia
První předloženo
30. července 2026
První předloženo, které splnilo kritéria kontroly kvality
30. července 2026
První zveřejněno (Aktuální)
5. srpna 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
5. srpna 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
30. července 2026
Naposledy ověřeno
1. července 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- Study 26-00680
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NE
Popis plánu IPD
No individual participant data is planned to be shared with other researchers.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
produkt vyrobený a vyvážený z USA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .