Telemedicine in Total Knee Arthroplasty Using Wearable Technology

July 22, 2019 updated by: Prem N Ramkumar, The Cleveland Clinic
Subjectivity, cost-effectiveness, and inconsistent reporting limit monitoring after total knee arthroplasty (TKA). This prospective study leverages machine learning wearable technology to remotely monitor patients before and after TKA with fidelity and reliability, without sacrificing safe triage needing increased perioperative attention. Patients will download a mobile app that pairs with a "smart" knee sleeve to (1) monitor activity via daily step count, (2) solicit patient-reported outcomes, (3) calculate max flexion, and (4) provide physical therapy compliance data. The primary objective of this study is to determine validity and acceptability of the technology; secondary objectives include perioperative benchmarking with characterization of post-operative recovery trajectories.

Study Overview

Status

Completed

Conditions

Detailed Description

Monitoring of pre-operative status and post-operative recovery from elective orthopaedic surgery is critical to delivering safe, value-based care. Measurement after TKA has traditionally been accomplished through clinician in-office assessments, validated surveys, or both; subjectivity, cost-effectiveness, and inconsistent reporting limit these assessments. Leveraging now ubiquitous smartphone technology and smart wearable technology with machine learning software offers the opportunity to remotely monitor patients before and after surgery. This provides surgeons, hospitals, and stakeholders the opportunity to objectively quantify (1) patient compliance, (2) value of a given surgical procedure with unprecedented benchmarking, and, more importantly, (3) the better triage of those needing increased perioperative attention. Regardless of the orthopaedic procedure, a motion-based machine learning software application to commercial mobile and wearable technology readily and inexpensively unlocks the potential of delivering value-based care through the low maintenance acquisition of both precision, small data that may then be extrapolated to population-level revelations from big data regardless of the joint or extremity. With the rise of telemedicine, clinical validation of the technology is of mutual interest to orthopaedic patients, surgeons, administrators, payers, and policymakers.

Study Type

Observational

Enrollment (Actual)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

A cohort of 25 patients undergoing primary TKA for osteoarthritis at our hospital will be enrolled into the study, which will receive IRB approval and be registered on ClinicalTrials.gov and RedCap. Patients will download the mobile application onto their personal smartphones (iOS) to record baseline activity and PROMs in the 2-4 weeks leading up to surgery. During the hospital admission, the knee sleeve will be fitted to the patient. The patient cohort will be followed for three months and four data points (both passive and active) will be extracted from the dashboard: PROMs, mean daily steps, ROM (particular attention to 2 weeks postoperatively), and home exercise plan (HEP) compliance.

Description

Inclusion Criteria:

  1. patients undergoing primary TKA for osteoarthritis
  2. patients who have an iOS smartphone and carry it with them daily
  3. patients who reside in a home and not a facility or rehabilitation center
  4. patients under the age of 80 years
  5. patients who preoperatively have not used any assist devices for more than a year due to the non-affected joint or other functional reasons, including back pain.

Exclusion criteria:

  1. patients receiving treatment for inflammatory arthritis
  2. patients receiving active or maintenance treatment for cancer or solid organ and/or marrow transplant
  3. patients with any other medical issues limiting mobility and function, including cardiopulmonary, gastrointestinal, and hematologic comorbidities
  4. patients indicated for TKA for post-traumatic or inflammatory arthritis
  5. patients who have ever had a periprosthetic joint infection of any joint
  6. patients who have a history of native septic arthritis in the operative joint
  7. patients who were functionally immobilized or residing anywhere other than a home (nursing facility, rehabilitation centers)
  8. patients who preoperatively used an assist device for more than a year (i.e. cane, walker)
  9. patients over the age of 80 years.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Primary TKA
A cohort of 25 patients undergoing primary TKA for osteoarthritis at our hospital will be enrolled into the study, which will receive IRB approval and be registered on ClinicalTrials.gov and RedCap. Patients will download the mobile application onto their personal smartphones (iOS) to record baseline activity and PROMs in the 2-4 weeks leading up to surgery. During the hospital admission, the knee sleeve will be fitted to the patient. The patient cohort will be followed for three months and four data points (both passive and active) will be extracted from the dashboard: PROMs, mean daily steps, ROM (particular attention to 2 weeks postoperatively), and home exercise plan (HEP) compliance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability
Time Frame: 3 months postoperative
Semi-structured interviewed
3 months postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Step Count in steps per day
Time Frame: Daily, from 4 weeks preoperatively to 3 months postoperatively totaling approximately 120 days
Passively collect steps for TKA patients before and after surgery. This will be used for comparing pre- and post-operative improvements.
Daily, from 4 weeks preoperatively to 3 months postoperatively totaling approximately 120 days
Maximum knee range of motion in degrees
Time Frame: Weekly, from 4 weeks preoperatively to 3 months postoperatively totaling approximately 16 weeks
Actively collect max extension and flexion for TKA patients before and after surgery. This will be used for comparing pre- and post-operative improvements.
Weekly, from 4 weeks preoperatively to 3 months postoperatively totaling approximately 16 weeks
Patient Reported Outcome Measures (linear numeric scale from 0 to 28)
Time Frame: Weekly, from 4 weeks preoperatively to 3 months postoperatively totaling approximately 16 weeks
Actively collect KOOS Jr., VAS pain scales. This will be used for comparing pre- and post-operative improvements.
Weekly, from 4 weeks preoperatively to 3 months postoperatively totaling approximately 16 weeks
Home Exercise Plan compliance
Time Frame: Daily, from day of surgery to 3 months postoperatively totaling approximately 90 days
Passively collect completion of at least one home exercise per day, as reported in binary fashion (yes or no)
Daily, from day of surgery to 3 months postoperatively totaling approximately 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Investigators

  • Study Director: Annabelle Visperas, BS, IRB Coordinator

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 2, 2018

Primary Completion (Actual)

May 15, 2019

Study Completion (Actual)

May 15, 2019

Study Registration Dates

First Submitted

December 9, 2017

First Submitted That Met QC Criteria

January 15, 2018

First Posted (Actual)

January 23, 2018

Study Record Updates

Last Update Posted (Actual)

July 24, 2019

Last Update Submitted That Met QC Criteria

July 22, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ClevelandCF02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Knee Arthritis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malta

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe