A Quantitative Assessment of Early Mobility in Total Knee Replacement Patients Using Smart Activity Tracker (Geospatial)
Primary Purpose
Knee Osteoarthritis
Status
Recruiting
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Garmin GPS activity tracker
Sponsored by
About this trial
This is an interventional other trial for Knee Osteoarthritis
Eligibility Criteria
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.
Sites / Locations
- Singapore General HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Geospatial
Arm Description
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)
Outcomes
Primary Outcome Measures
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)
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)
Oxford Knee
Using the Oxford Knee questionnaire to get the oxford knee score
Oxford Knee
Using the Oxford Knee questionnaire to get the oxford knee score
SF 36 Health survey
SF36 questionnaires to get SF-36 scores
SF 36 Health survey
SF36 questionnaires to get SF-36 scores
Expectation met for surgery
Patient satisfaction form
Expectation met for surgery
Patient satisfaction form
Overall result of surgery
Subject's summary and outcomes form; data collected from Orthopaedic diagnostis center (ODC)
Overall result of surgery
Subject's summary and outcomes form; data collected from Orthopaedic diagnostis center (ODC)
Length of stay
the number of nights spend in the hospital from the day of surgery
Premorbid history
Patients reported ambulation status before surgery, including the use of walking aids and assistance level required
Early ambulation rate
Percentage of patients who start walking postoperative day (POD) 1
Knee range-of-motion
measure knee ROM
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
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)
Discharge Destination
Where the patient will be going to after discharge from SGH
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
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05076539
First Posted
September 20, 2021
Last Updated
March 30, 2022
Sponsor
Singapore General Hospital
Collaborators
Curtin University
1. Study Identification
Unique Protocol Identification Number
NCT05076539
Brief Title
A Quantitative Assessment of Early Mobility in Total Knee Replacement Patients Using Smart Activity Tracker
Acronym
Geospatial
Official Title
A Quantitative Assessment of Early Mobility in Total Knee Replacement Patients Using Smart Activity Tracker
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 11, 2018 (Actual)
Primary Completion Date
October 13, 2022 (Anticipated)
Study Completion Date
January 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Singapore General Hospital
Collaborators
Curtin University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Geospatial
Arm Type
Other
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
Garmin GPS activity tracker
Intervention Description
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).
Primary Outcome Measure Information:
Title
Knee Society Clinical Rating system
Description
Measuring knee range of motion, knee extension lag, knee alignment in standing using the knee society clinical rating system (KSS Scores)
Time Frame
pre-surgery
Title
Knee Society Clinical Rating system
Description
Measuring knee range of motion, knee extension lag, knee alignment in standing using the knee society clinical rating system (KSS Scores)
Time Frame
6 months post surgery
Title
Oxford Knee
Description
Using the Oxford Knee questionnaire to get the oxford knee score
Time Frame
pre-surgery
Title
Oxford Knee
Description
Using the Oxford Knee questionnaire to get the oxford knee score
Time Frame
6 months post surgery
Title
SF 36 Health survey
Description
SF36 questionnaires to get SF-36 scores
Time Frame
pre-surgery
Title
SF 36 Health survey
Description
SF36 questionnaires to get SF-36 scores
Time Frame
6 months post surgery
Title
Expectation met for surgery
Description
Patient satisfaction form
Time Frame
pre-surgery
Title
Expectation met for surgery
Description
Patient satisfaction form
Time Frame
6 months post surgery
Title
Overall result of surgery
Description
Subject's summary and outcomes form; data collected from Orthopaedic diagnostis center (ODC)
Time Frame
pre-surgery
Title
Overall result of surgery
Description
Subject's summary and outcomes form; data collected from Orthopaedic diagnostis center (ODC)
Time Frame
6 months post surgery
Title
Length of stay
Description
the number of nights spend in the hospital from the day of surgery
Time Frame
up to 6 months post surgery
Title
Premorbid history
Description
Patients reported ambulation status before surgery, including the use of walking aids and assistance level required
Time Frame
up to 6 months post surgery
Title
Early ambulation rate
Description
Percentage of patients who start walking postoperative day (POD) 1
Time Frame
up to 6 months post surgery
Title
Knee range-of-motion
Description
measure knee ROM
Time Frame
up to 6 months post surgery
Title
Ability to perform a straight leg raise
Description
If patient is able to lift their leg independently. Lag is measured by a goniometer measured by a goniometer
Time Frame
up to 6 months post surgery
Title
Type of walking aids used
Description
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)
Time Frame
up to 6 months post surgery
Title
Discharge Destination
Description
Where the patient will be going to after discharge from SGH
Time Frame
up to 6 months post surgery
Title
Data Collected from Garmin GPS-activity tracker
Description
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
Time Frame
Pre-surgery for 1 week
Title
Data Collected from Garmin GPS-activity tracker
Description
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
Time Frame
6 months post surgery for 1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Celia Tan Ia Choo
Phone
91721220
Email
celia.tan.i.c@singhealth.com.sg
First Name & Middle Initial & Last Name or Official Title & Degree
Yeo Hwee Shan
Email
yeo.hwee.shan@sgh.com.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Celia Tan Ia Choo
Organizational Affiliation
Singapore General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Singapore General Hospital
City
Singapore
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Office
Email
research.office@sgh.com.sg
First Name & Middle Initial & Last Name & Degree
Celia Tan Ia Choo
Email
celia.tan.i.c@singhealth.com.sg
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Quantitative Assessment of Early Mobility in Total Knee Replacement Patients Using Smart Activity Tracker
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