Home Monitoring After Primary Total Knee Arthroplasty

Osteoarthritis, Knee Clinical Trial

Official title:

Feasibility of Home Monitoring After Primary Total Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03032068
• Other study ID #: 15-1051
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: May 2, 2017

Study information

• Verified date: January 2022
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 2, 2017
• Est. primary completion date: May 2, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis, Knee

Intervention

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.

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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
Secondary	Rehab Compliance	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
Secondary	Change From Preoperative to Postoperative Knee Range of Motion	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
Secondary	Change From Preoperative to Postoperative Timed Up and Go Test	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
Secondary	Visual Analog Scale for Pain (Knee-related Pain at Its Worst Over a 24 Hour Period)	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
Secondary	Knee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS Pain	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
Secondary	Knee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS PS (Physical Function Short Form)	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
Secondary	Knee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS QOL	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