Home Monitoring After Primary Total Knee Arthroplasty

NCT03032068 | Completed Results

• 1 other identifier: 15-1051
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Rehab Compliance

  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

  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

  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)

  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

  Once preoperatively then postoperatively once weekly from the date of discharge until the 12 week follow-up appointment has occurred

Study Arms (1)

At-Home Monitoring

EXPERIMENTAL

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

Interventions

At-Home Monitoring OTHER

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.

At-Home Monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Revision or simultaneous bilateral TKA
• English is not the patient's preferred language for healthcare discussions
• Currently participating in any other research study

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Jayson Zadzilka
• Organization: Cleveland Clinic

zadzilj@ccf.org

216-445-8023

Study Officials

• Carlos Higuera, MD

  Staff Surgeon

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Surgeon

Study Record Dates

• First Submitted: July 28, 2016
• First Posted: January 26, 2017
• Study Start: July 1, 2016
• Primary Completion: May 2, 2017
• Study Completion: May 2, 2017
• Last Updated: January 18, 2022
• Results First Posted: January 18, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)