Telemedicine in Total Knee Arthroplasty Using Wearable Technology

NCT03406455 | Completed

• 1 other identifier: ClevelandCF02
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Arthritis

Keywords

wearable; mhealth

Outcome Measures

Primary Outcomes (1)

• Acceptability

  Semi-structured interviewed

  3 months postoperative

Secondary Outcomes (4)

• Step Count in steps per day

  Daily, from 4 weeks preoperatively to 3 months postoperatively totaling approximately 120 days

• Maximum knee range of motion in degrees

  Weekly, from 4 weeks preoperatively to 3 months postoperatively totaling approximately 16 weeks

• Patient Reported Outcome Measures (linear numeric scale from 0 to 28)

  Weekly, from 4 weeks preoperatively to 3 months postoperatively totaling approximately 16 weeks

• Home Exercise Plan compliance

  Daily, from day of surgery to 3 months postoperatively totaling approximately 90 days

Study Arms (1)

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.

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• patients undergoing primary TKA for osteoarthritis
• patients who have an iOS smartphone and carry it with them daily
• patients who reside in a home and not a facility or rehabilitation center
• patients under the age of 80 years
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (3)

• Ramkumar PN, Muschler GF, Spindler KP, Harris JD, McCulloch PC, Mont MA. Open mHealth Architecture: A Primer for Tomorrow's Orthopedic Surgeon and Introduction to Its Use in Lower Extremity Arthroplasty. J Arthroplasty. 2017 Apr;32(4):1058-1062. doi: 10.1016/j.arth.2016.11.019. Epub 2016 Nov 17.

  PMID: 27956125 BACKGROUND

• Ramkumar PN, Navarro SM, Chughtai M, La T Jr, Fisch E, Mont MA. The Patient Experience: An Analysis of Orthopedic Surgeon Quality on Physician-Rating Sites. J Arthroplasty. 2017 Sep;32(9):2905-2910. doi: 10.1016/j.arth.2017.03.053. Epub 2017 Apr 4.

  PMID: 28455178 BACKGROUND

• Ramkumar PN, Harris JD, Noble PC. Patient-reported outcome measures after total knee arthroplasty: a systematic review. Bone Joint Res. 2015 Jul;4(7):120-7. doi: 10.1302/2046-3758.47.2000380.

  PMID: 26220999 BACKGROUND

Study Officials

• Annabelle Visperas, BS

  IRB Coordinator

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic Surgery Resident

Study Record Dates

• First Submitted: December 9, 2017
• First Posted: January 23, 2018
• Study Start: July 2, 2018
• Primary Completion: May 15, 2019
• Study Completion: May 15, 2019
• Last Updated: July 24, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)