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Knee Positioning After Total Knee Replacement

30 de julho de 2026 atualizado 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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 estudo

Intervencional

Inscrição (Estimado)

150

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Knee Flexion
Participants in this arm will receive the knee flexion intervention.
Outro: 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 Ativo: 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.
Procedimento: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Knee Passive Total Arc of Motion
Prazo: 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
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
Knee Passive Total Arc of Motion
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Icahn School of Medicine at Mount Sinai

Investigadores

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

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de setembro de 2026

Conclusão Primária (Estimado)

1 de fevereiro de 2028

Conclusão do estudo (Estimado)

1 de fevereiro de 2029

Datas de inscrição no estudo

Enviado pela primeira vez

30 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

30 de julho de 2026

Primeira postagem (Real)

5 de agosto de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

5 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

30 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • Study 26-00680

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

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

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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