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Knee Positioning After Total Knee Replacement

30 de julio de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

150

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Knee Flexion
Participants in this arm will receive the knee flexion intervention.
Otro: Knee Flexion
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.
Comparador activo: 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.
Procedimiento: Standard 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Knee Passive Total Arc of Motion
Periodo de tiempo: 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.
At 6 weeks after surgery
Maximum Pain Intensity
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Knee Passive Total Arc of Motion
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.
Within 7 days, 30 days, and 90 days after surgery
Percentage of Participants with a Hospital Readmission
Periodo de tiempo: 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
Percentage of Participants with Deep Vein Thrombosis
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Percentage of Participants with a Blood Transfusion
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Percentage of Participants with a Knee Revision Surgery
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Icahn School of Medicine at Mount Sinai

Investigadores

  • Investigador principal: Brett Hayden, MD, Icahn School of Medicine at Mount Sinai

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de septiembre de 2026

Finalización primaria (Estimado)

1 de febrero de 2028

Finalización del estudio (Estimado)

1 de febrero de 2029

Fechas de registro del estudio

Enviado por primera vez

30 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

30 de julio de 2026

Publicado por primera vez (Actual)

5 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

5 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

30 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • Study 26-00680

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

No individual participant data is planned to be shared with other researchers.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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