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- Klinische proef NCT03032068
Home Monitoring After Primary Total Knee Arthroplasty
Feasibility of Home Monitoring After Primary Total Knee Arthroplasty
Studie Overzicht
Gedetailleerde beschrijving
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Ohio
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Cleveland, Ohio, Verenigde Staten, 44195
- Cleveland Clinic Foundation
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Onderzoek naar gezondheidsdiensten
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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.
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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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.
Tijdsspanne: daily, from the date of discharge until the 12 week postoperative follow-up appointment has occurred
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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
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Rehab Compliance
Tijdsspanne: Percentage of exercises completed 2-3 times daily, from the date of discharge up to approximately 4 weeks postoperatively when outpatient physical therapy begins
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Percentage of required at-home therapy exercises completed each session, as well as the total percentage completed during all home therapy sessions
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Percentage of exercises completed 2-3 times daily, from the date of discharge up to approximately 4 weeks postoperatively when outpatient physical therapy begins
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Change From Preoperative to Postoperative Knee Range of Motion
Tijdsspanne: Once preoperatively then postoperatively 2-3 times daily from the date of discharge until the 12 week postoperative follow-up appointment has occurred
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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
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Once preoperatively then postoperatively 2-3 times daily from the date of discharge until the 12 week postoperative follow-up appointment has occurred
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Change From Preoperative to Postoperative Timed Up and Go Test
Tijdsspanne: Once preoperatively then postoperatively 2-3 times daily from the date of discharge until the 12 week postoperative follow-up appointment has occurred
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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.
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Once preoperatively then postoperatively 2-3 times daily from the date of discharge until the 12 week postoperative follow-up appointment has occurred
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Visual Analog Scale for Pain (Knee-related Pain at Its Worst Over a 24 Hour Period)
Tijdsspanne: Once preoperatively then postoperatively 2-3 times daily from the date of discharge until the 12 week postoperative follow-up appointment has occurred
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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.
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Once preoperatively then postoperatively 2-3 times daily from the date of discharge until the 12 week postoperative follow-up appointment has occurred
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Knee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS Pain
Tijdsspanne: Once preoperatively then postoperatively once weekly from the date of discharge until the 12 week follow-up appointment has occurred
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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.
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Once preoperatively then postoperatively once weekly from the date of discharge until the 12 week follow-up appointment has occurred
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Knee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS PS (Physical Function Short Form)
Tijdsspanne: Once preoperatively then postoperatively once weekly from the date of discharge until the 12 week follow-up appointment has occurred
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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.
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Once preoperatively then postoperatively once weekly from the date of discharge until the 12 week follow-up appointment has occurred
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Knee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS QOL
Tijdsspanne: Once preoperatively then postoperatively once weekly from the date of discharge until the 12 week follow-up appointment has occurred
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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.
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Once preoperatively then postoperatively once weekly from the date of discharge until the 12 week follow-up appointment has occurred
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Carlos Higuera, MD, Staff Surgeon
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 15-1051
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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