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Home Monitoring After Primary Total Knee Arthroplasty

14. januar 2022 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

10

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Ohio
      • Cleveland, Ohio, Forente stater, 44195
        • Cleveland Clinic Foundation

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Helsetjenesteforskning
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Annen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
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.
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Rehab Compliance
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

The Cleveland Clinic

Etterforskere

  • Hovedetterforsker: Carlos Higuera, MD, Staff Surgeon

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juli 2016

Primær fullføring (Faktiske)

2. mai 2017

Studiet fullført (Faktiske)

2. mai 2017

Datoer for studieregistrering

Først innsendt

28. juli 2016

Først innsendt som oppfylte QC-kriteriene

24. januar 2017

Først lagt ut (Anslag)

26. januar 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. januar 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. januar 2022

Sist bekreftet

1. januar 2022

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 15-1051

Plan for individuelle deltakerdata (IPD)

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NEI

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