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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Other: Garmin GPS activity tracker


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Geospatial<br>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<br>* 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).<br>|

What is the study measuring?
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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 |