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Home Monitoring After Primary Total Knee Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03032068
Recruitment Status : Completed
First Posted : January 26, 2017
Last Update Posted : May 23, 2017
Sponsor:
Information provided by (Responsible Party):
Carlos Higuera-Rueda, The Cleveland Clinic

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Other: At-Home Monitoring Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Feasibility of Home Monitoring After Primary Total Knee Arthroplasty
Study Start Date : July 2016
Actual Primary Completion Date : May 2, 2017
Actual Study Completion Date : May 2, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
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.
Other: 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.




Primary Outcome Measures :
  1. At-Home Monitoring Reliability, measured as the proportion of actual data received from the patient's home compared to the amount of data expected over the 12 week study period. [ Time Frame: 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.


Secondary Outcome Measures :
  1. At-Home Monitoring Accuracy [ Time Frame: Once preoperatively and then postoperatively at the following time points: 4 Homecare visits within the first 4 weeks postoperatively, a 4 week follow-up, 8 week follow-up, and 12 week follow-up ]
    Data recorded by the sensors and home monitoring application are verified manually during clinical visits.

  2. Rehab Compliance [ Time Frame: 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

  3. Knee Range of Motion [ Time Frame: Once preoperatively then postoperatively 2-3 times daily from the date of discharge until the 12 week postoperative follow-up appointment has occurred ]
    Knee range of motion is recorded daily using sensors above and below the knee. This data will be compared to the knee range of motion measurements recorded by a therapist during postoperative home care or clinical visits.

  4. Timed Up and Go Test [ Time Frame: Once preoperatively then postoperatively 2-3 times daily from the date of discharge until the 12 week postoperative follow-up appointment has occurred ]
    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 will be recorded electronically by the patient at home and compared to the times recorded by the therapist during home care and clinical visits.

  5. Pain [ Time Frame: 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

  6. Knee injury and Osteoarthritis Outcome Score (KOOS) - KOOS Pain [ Time Frame: 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, where 0 means no pain and 36 is extreme pain.

  7. Knee injury and Osteoarthritis Outcome Score (KOOS) - KOOS Function [ Time Frame: 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, where 0 means no functional difficulty and 28 is extreme difficulty.

  8. Knee injury and Osteoarthritis Outcome Score (KOOS) - KOOS QOL [ Time Frame: 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, where 0 means the knee does not affect quality of life and 16 indicates that the knee is a constant problem affecting quality of life.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03032068


Locations
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United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
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Principal Investigator: Carlos Higuera, MD Staff Surgeon
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Responsible Party: Carlos Higuera-Rueda, Staff Surgeon, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03032068    
Other Study ID Numbers: 15-1051
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: May 23, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases