A Quantitative Assessment of Early Mobility in Total Knee Replacement Patients Using Smart Activity Tracker

Overview

This study aims to evaluate the patients' mobility and quality of life prior to their total knee replacement surgery and their progress pre-operatively and 6 months post-operatively using the smart activity tracker. We hypothesize that mobility limitation presents a strong correlation with reduced quality of life.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 9, 2021

Detailed Description

The present study is to determine the effect of TKA based on their mobility and QOL pre and post surgery. The GPS and accelerometry-based tracker will be able to provide quantitative-based outcomes to indicate the physical activity of patients after TKR remains at or above pre-surgical levels. A total of 50 participants are to be enrolled in this cross-sectional study. Patients who will be required to undergo unilateral total knee replacement will be recruited when fulfilling the respective inclusion and exclusion criteria. The patients will undergo the standard consultations and rehabilitation pre – and post operative care, no changes to the treatment itself will be made. After recruitment and counseling by the surgeon for TKR, the patients will have pre-operative baseline clinical scores taken prior to surgery. They will subsequently have their TKR surgery. Post-operatively, they will be followed up prospectively at the clinics as well as Orthopaedics Diagnostic Centre. Their outcome will be evaluated using validated scoring system, Oxford Knee Score, SF-36, Knee Society Clinical Rating System, satisfaction questionnaire, as well as be provided with a GPS-activity tracker. 50 patients will be issued a Garmin GPS-activity tracker where they will be required to wear for 24 hours for 1 week, prior to each timepoint (pre-operatively and 6 months post surgery). The de-identified raw data gathered from the Garmin tracker will be collected by Curtin University for their analysis. The patients will undergo the standard consultations and rehabilitation pre – and postoperative care, no changes to the treatment itself will be made. Standard consultations/review by orthopaedic specialist – Pre-surgery – 6 months post surgery Standard Orthopaedic Diagnostic Center (ODC) data collection timepoints – Pre-surgrey – 6 months Standard rehabilitation care – Upon discharge – 2 – 3 weeks post discharge in outpatient services (OPS) On top of the standard consultations and rehabilitation pre – and postoperative care, the patients will be monitored on their normal lifestyle at home using a tracker worn on their wrists for 1 week, pre-operatively and 6 months post surgery.

Interventions

  • Other: Garmin GPS activity tracker
    • 50 patients will be issued a Garmin GPS-activity tracker where they will be required to wear for 24 hours for 1 week, prior to each timepoint (pre-operatively and 6 months post surgery).

Arms, Groups and Cohorts

  • Other: Geospatial
    • 50 patients will be issued a Garmin GPS-activity tracker where they will be required to wear for 24 hours for 1 week, prior to each timepoint (pre-operatively and 6 months post surgery)

Clinical Trial Outcome Measures

Primary Measures

  • Knee Society Clinical Rating system
    • Time Frame: pre-surgery
    • Measuring knee range of motion, knee extension lag, knee alignment in standing using the knee society clinical rating system (KSS Scores)
  • Knee Society Clinical Rating system
    • Time Frame: 6 months post surgery
    • Measuring knee range of motion, knee extension lag, knee alignment in standing using the knee society clinical rating system (KSS Scores)
  • Oxford Knee
    • Time Frame: pre-surgery
    • Using the Oxford Knee questionnaire to get the oxford knee score
  • Oxford Knee
    • Time Frame: 6 months post surgery
    • Using the Oxford Knee questionnaire to get the oxford knee score
  • SF 36 Health survey
    • Time Frame: pre-surgery
    • SF36 questionnaires to get SF-36 scores
  • SF 36 Health survey
    • Time Frame: 6 months post surgery
    • SF36 questionnaires to get SF-36 scores
  • Expectation met for surgery
    • Time Frame: pre-surgery
    • Patient satisfaction form
  • Expectation met for surgery
    • Time Frame: 6 months post surgery
    • Patient satisfaction form
  • Overall result of surgery
    • Time Frame: pre-surgery
    • Subject’s summary and outcomes form; data collected from Orthopaedic diagnostis center (ODC)
  • Overall result of surgery
    • Time Frame: 6 months post surgery
    • Subject’s summary and outcomes form; data collected from Orthopaedic diagnostis center (ODC)
  • Length of stay
    • Time Frame: up to 6 months post surgery
    • the number of nights spend in the hospital from the day of surgery
  • Premorbid history
    • Time Frame: up to 6 months post surgery
    • Patients reported ambulation status before surgery, including the use of walking aids and assistance level required
  • Early ambulation rate
    • Time Frame: up to 6 months post surgery
    • Percentage of patients who start walking postoperative day (POD) 1
  • Knee range-of-motion
    • Time Frame: up to 6 months post surgery
    • measure knee ROM
  • Ability to perform a straight leg raise
    • Time Frame: up to 6 months post surgery
    • If patient is able to lift their leg independently. Lag is measured by a goniometer measured by a goniometer
  • Type of walking aids used
    • Time Frame: up to 6 months post surgery
    • The type of walking aids required, namely, walking frame, broad- and narrow-based quadstick, or walking stick (in descending order of base of support provided)
  • Discharge Destination
    • Time Frame: up to 6 months post surgery
    • Where the patient will be going to after discharge from SGH
  • Data Collected from Garmin GPS-activity tracker
    • Time Frame: Pre-surgery for 1 week
    • Latitude and longitudinal location coordinates to determine an individual’s activity space Distance travelled Walking speed Heart rate Calories burned Energy expenditure Steps count Physical activity
  • Data Collected from Garmin GPS-activity tracker
    • Time Frame: 6 months post surgery for 1 week
    • Latitude and longitudinal location coordinates to determine an individual’s activity space Distance travelled Walking speed Heart rate Calories burned Energy expenditure Steps count Physical activity

Participating in This Clinical Trial

Inclusion Criteria

  • Patients who are referred by the Orthopaedic surgeon and are diagnosed with Knee Osteoarthritis, and consented to unilateral total knee replacement. – Able to ambulate with or without walking aid. – Ability to provide informed consent. Exclusion Criteria:

  • Patients who have severe bilateral Knee Osteoarthritis, affecting their ability to walk and only one will be operated on. – Patients with pre-existing cognitive issues, such as dementia. – Patients planning for another surgery within 6 months after their TKR. – Patients with existing co-morbidities that limit their walking ability, such as severe respiratory distress syndromes.

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Singapore General Hospital
  • Collaborator
    • Curtin University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Celia Tan Ia Choo, Principal Investigator, Singapore General Hospital
  • Overall Contact(s)
    • Celia Tan Ia Choo, 91721220, celia.tan.i.c@singhealth.com.sg

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