Clinical trial NCT03032068: Home Monitoring After Primary Total Knee Arthroplasty
Official title: Feasibility of Home Monitoring After Primary Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2017-01-26
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: daily, from the date of discharge until the 12 week postoperative follow-up appointment has occurred
Secondary outcomes:
measure: Rehab Compliance
timeFrame: Percentage of exercises completed 2-3 times daily, from the date of discharge up to approximately 4 weeks postoperatively when outpatient physical therapy begins
measure: Change From Preoperative to Postoperative Knee Range of Motion
timeFrame: Once preoperatively then postoperatively 2-3 times daily from the date of discharge until the 12 week postoperative follow-up appointment has occurred
measure: Change From Preoperative to Postoperative Timed Up and Go Test
timeFrame: Once preoperatively then postoperatively 2-3 times daily from the date of discharge until the 12 week postoperative follow-up appointment has occurred
measure: Visual Analog Scale for Pain (Knee-related Pain at Its Worst Over a 24 Hour Period)
timeFrame: Once preoperatively then postoperatively 2-3 times daily from the date of discharge until the 12 week postoperative follow-up appointment has occurred
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS Pain
timeFrame: Once preoperatively then postoperatively once weekly from the date of discharge until the 12 week follow-up appointment has occurred
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS PS (Physical Function Short Form)
timeFrame: Once preoperatively then postoperatively once weekly from the date of discharge until the 12 week follow-up appointment has occurred
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS QOL
timeFrame: Once preoperatively then postoperatively once weekly from the date of discharge until the 12 week follow-up appointment has occurred
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: Staff Surgeon
name: Carlos Higuera, MD
role: PRINCIPAL_INVESTIGATOR
References: