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Home Monitoring After Primary Total Knee Arthroplasty

14 de enero de 2022 actualizado por: Carlos Higuera-Rueda, The Cleveland Clinic

Feasibility of Home Monitoring After Primary Total Knee Arthroplasty

Home monitoring technologies have recently emerged in many different areas of healthcare. These technologies are being used to provide rehabilitation to patients, and to prevent, identify, and manage complications. The investigators are proposing a method to monitor and communicate with patients during the first 12 weeks after total knee arthroplasty (TKA) using an electronic home-based patient monitoring system with unique connectivity capabilities and prescriptive controls. The investigators will prospectively, electronically capture range of motion and gait parameters at specified intervals using Bluetooth sensors worn by the patient. The unique in-home patient monitoring platform will be utilized by 10 TKA patients once they return home following surgery. The investigators hypothesize that the use of an internet based home patient monitoring technology platform will reliably provide information related to the patients' pain and function and enhance patient feedback and communication after TKA. The hypothesis will be tested with the following aim: 1) To test the reliability of all technology utilized within the patient's home including but not limited to the sensors, the communication controller, the patient interface (Android tablet) and the internet by prospectively comparing between data collected through the home monitoring technology and traditional clinical measurements taken during physical therapy and surgical follow-up visits.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Over one million primary total hip and total knee arthroplasty (TKA) surgeries are being performed annually in the U.S. and this number is expected to increase over the next seven years, along with a simultaneously projected shortage of trained orthopaedic surgeons to care for these patients. This proposal addresses the optimization of the surgeons' clinical time through utilization of innovative home based technologies to monitor and communicate with patients during the first 12 weeks after total knee arthroplasty. This will be accomplished by establishing home monitoring connectivity with novel technology and measure validated patient-reported outcomes, knee ROM and gait parameters in a postoperative TKA patient's native living environment. It will allow the investigators to prospectively, electronically capture clinically relevant TKA outcomes at the patient's home and provide insight into postoperative rehabilitation progress, predictors of suboptimal clinical outcomes, and guide future randomized controlled trial development to improve outcomes.

Tipo de estudio

Intervencionista

Inscripción (Actual)

10

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.

Ubicaciones de estudio

  • Estados Unidos
    • Ohio
      • Cleveland, Ohio, Estados Unidos, 44195
        • Cleveland Clinic Foundation

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

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Unilateral primary TKA
  • Surgery is performed at Cleveland Clinic Main Campus or at Lutheran Hospital
  • Patient must reside within 75 miles (driving distance) from Cleveland Clinic Main Campus
  • Patient expected to utilize Cleveland Clinic Home Care Services after surgery

Exclusion Criteria:

  • Revision or simultaneous bilateral TKA
  • English is not the patient's preferred language for healthcare discussions
  • Currently participating in any other research study

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: Investigación de servicios de salud
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: At-Home Monitoring
Patients will follow-up in clinic postoperatively at 4, 8, and 12 weeks and their recovery will also be monitored using sensors and communication devices while they are at home after surgery.
Otro: At-Home Monitoring
Patient reported outcomes, functional measures such as the maximum attainable range of motion (AROM) and the number of steps taken will be tracked using sensors worn by the patient. The AROM sensor values will be verified with range of motion measurements taken using a goniometer during therapy and MD visits.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Overall Reliability of Monitoring Technology, Measured as Proportion of Actual Data Received From the Patient's Home Compared to the Amount of Data Expected (Based on Activities That Were Reported as Completed by Patients) Over the 12 Week Study Period.
Periodo de tiempo: daily, from the date of discharge until the 12 week postoperative follow-up appointment has occurred

The investigators will determine the reliability of the at-home monitoring technology for recording and transmitting data from the patient's home to the healthcare provider. This will be measured for each patient individually and then combined to form an aggregate measurement.

Reliability of the technology to collect data was calculated for each patient individually by counting the number of times data (range of motion, TUG test results, VAS Pain score, etc) was received and dividing that number by the number of times data was expected (activities reported as complete by patients). This was then converted into a percentage. Additionally, this number was aggregated by combining the numerators (activities received) for all patients and denominators (activities complete) for all patients and determining the overall reliability of the technology.
daily, from the date of discharge until the 12 week postoperative follow-up appointment has occurred

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Rehab Compliance
Periodo de tiempo: Percentage of exercises completed 2-3 times daily, from the date of discharge up to approximately 4 weeks postoperatively when outpatient physical therapy begins
Percentage of required at-home therapy exercises completed each session, as well as the total percentage completed during all home therapy sessions
Percentage of exercises completed 2-3 times daily, from the date of discharge up to approximately 4 weeks postoperatively when outpatient physical therapy begins
Change From Preoperative to Postoperative Knee Range of Motion
Periodo de tiempo: Once preoperatively then postoperatively 2-3 times daily from the date of discharge until the 12 week postoperative follow-up appointment has occurred
Change from Preoperative to Postoperative Knee Range of Motion, Knee range of motion is recorded daily using sensors above and below the knee. Please note: only data from sensors is being reported
Once preoperatively then postoperatively 2-3 times daily from the date of discharge until the 12 week postoperative follow-up appointment has occurred
Change From Preoperative to Postoperative Timed Up and Go Test
Periodo de tiempo: Once preoperatively then postoperatively 2-3 times daily from the date of discharge until the 12 week postoperative follow-up appointment has occurred
Change from Preoperative to Postoperative Timed Up and Go Test. The time that a patient takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. This time was recorded electronically by the patient at home using the tablet.
Once preoperatively then postoperatively 2-3 times daily from the date of discharge until the 12 week postoperative follow-up appointment has occurred
Visual Analog Scale for Pain (Knee-related Pain at Its Worst Over a 24 Hour Period)
Periodo de tiempo: Once preoperatively then postoperatively 2-3 times daily from the date of discharge until the 12 week postoperative follow-up appointment has occurred
Knee-related pain was measured using a visual analog scale with numeric values added to the line. Zero (0) is the minimum value and 10 is the maximum value. A score of 0 indicates no pain and a score of 10 indicates the worst pain imaginable.
Once preoperatively then postoperatively 2-3 times daily from the date of discharge until the 12 week postoperative follow-up appointment has occurred
Knee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS Pain
Periodo de tiempo: Once preoperatively then postoperatively once weekly from the date of discharge until the 12 week follow-up appointment has occurred
We will assess KOOS Pain using 9 questions, each response given a point value from 0 to 4. The sum of these points will total between 0 and 36 points. This score will be normalized to a 100 point scale where 100 means no pain and 0 is extreme pain.
Once preoperatively then postoperatively once weekly from the date of discharge until the 12 week follow-up appointment has occurred
Knee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS PS (Physical Function Short Form)
Periodo de tiempo: Once preoperatively then postoperatively once weekly from the date of discharge until the 12 week follow-up appointment has occurred
We will assess KOOS Function using 7 questions, each response given a point value from 0 to 4. The sum of these points will total between 0 and 28 points. This total will be normalized to a 100 point scale where 100 means no functional difficulty and 0 is extreme difficulty.
Once preoperatively then postoperatively once weekly from the date of discharge until the 12 week follow-up appointment has occurred
Knee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS QOL
Periodo de tiempo: Once preoperatively then postoperatively once weekly from the date of discharge until the 12 week follow-up appointment has occurred
We will assess KOOS QOL using 4 questions, each response given a point value from 0 to 4. The sum of these points will total between 0 and 16 points, which will then be normalized to a 100 point scale. One hundred (100) means the knee does not affect quality of life and 0 indicates that the knee is a constant problem affecting quality of life.
Once preoperatively then postoperatively once weekly from the date of discharge until the 12 week follow-up appointment has occurred

Colaboradores e Investigadores

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

Patrocinador

The Cleveland Clinic

Investigadores

  • Investigador principal: Carlos Higuera, MD, Staff Surgeon

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

1 de julio de 2016

Finalización primaria (Actual)

2 de mayo de 2017

Finalización del estudio (Actual)

2 de mayo de 2017

Fechas de registro del estudio

Enviado por primera vez

28 de julio de 2016

Primero enviado que cumplió con los criterios de control de calidad

24 de enero de 2017

Publicado por primera vez (Estimar)

26 de enero de 2017

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

18 de enero de 2022

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

14 de enero de 2022

Última verificación

1 de enero de 2022

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 15-1051

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

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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