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

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 Overview

• Status: Recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Other: Garmin GPS activity tracker

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Celia Tan Ia Choo; Phone Number: 91721220; Email: celia.tan.i.c@singhealth.com.sg
• Study Contact Backup: Name: Yeo Hwee Shan; Email: yeo.hwee.shan@sgh.com.sg

Study Locations

• Singapore
  • Singapore, Singapore
    • Recruiting
    • Singapore General Hospital
    • Contact: Research Office; Email: research.office@sgh.com.sg
    • Contact: Celia Tan Ia Choo; Email: celia.tan.i.c@singhealth.com.sg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee Society Clinical Rating system	Measuring knee range of motion, knee extension lag, knee alignment in standing using the knee society clinical rating system (KSS Scores)	pre-surgery
Knee Society Clinical Rating system	Measuring knee range of motion, knee extension lag, knee alignment in standing using the knee society clinical rating system (KSS Scores)	6 months post surgery
Oxford Knee	Using the Oxford Knee questionnaire to get the oxford knee score	pre-surgery
Oxford Knee	Using the Oxford Knee questionnaire to get the oxford knee score	6 months post surgery
SF 36 Health survey	SF36 questionnaires to get SF-36 scores	pre-surgery
SF 36 Health survey	SF36 questionnaires to get SF-36 scores	6 months post surgery
Expectation met for surgery	Patient satisfaction form	pre-surgery
Expectation met for surgery	Patient satisfaction form	6 months post surgery
Overall result of surgery	Subject's summary and outcomes form; data collected from Orthopaedic diagnostis center (ODC)	pre-surgery
Overall result of surgery	Subject's summary and outcomes form; data collected from Orthopaedic diagnostis center (ODC)	6 months post surgery
Length of stay	the number of nights spend in the hospital from the day of surgery	up to 6 months post surgery
Premorbid history	Patients reported ambulation status before surgery, including the use of walking aids and assistance level required	up to 6 months post surgery
Early ambulation rate	Percentage of patients who start walking postoperative day (POD) 1	up to 6 months post surgery
Knee range-of-motion	measure knee ROM	up to 6 months post surgery
Ability to perform a straight leg raise	If patient is able to lift their leg independently. Lag is measured by a goniometer measured by a goniometer	up to 6 months post surgery
Type of walking aids used	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)	up to 6 months post surgery
Discharge Destination	Where the patient will be going to after discharge from SGH	up to 6 months post surgery
Data Collected from Garmin GPS-activity tracker	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	Pre-surgery for 1 week
Data Collected from Garmin GPS-activity tracker	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	6 months post surgery for 1 week

Collaborators and Investigators

• Sponsor: Singapore General Hospital
• Collaborators: Curtin University
• Investigators: Principal Investigator: Celia Tan Ia Choo, Singapore General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2018
• Primary Completion (Anticipated): October 13, 2022
• Study Completion (Anticipated): January 30, 2023

Study Registration Dates

• First Submitted: September 20, 2021
• First Submitted That Met QC Criteria: October 1, 2021
• First Posted (Actual): October 13, 2021

Study Record Updates

• Last Update Posted (Actual): April 1, 2022
• Last Update Submitted That Met QC Criteria: March 30, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: Geospatial; 2017-2972 (Other Identifier: Singhealth)

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
• product manufactured in and exported from the U.S.: No