Knee OsteoarthritisGeospatialNCT05076539
A Quantitative Assessment of Early Mobility in Total Knee Replacement Patients Using Smart Activity Tracker
A study testing Garmin GPS activity tracker in people with Knee Osteoarthritis, run by Singapore General Hospital at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Garmin GPS activity tracker
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSingapore
- Study dates
- 11 Jun 2018to 30 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Yeo Hwee Shan contact
Singapore1 site, 1 recruiting
- Recruiting
Singapore General Hospital
Singapore
Research Office, research.office@sgh.com.sg
Celia Tan Ia Choo, celia.tan.i.c@singhealth.com.sg
About this study
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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Garmin GPS activity tracker
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Garmin GPS activity trackerOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Geospatial | Other | 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) Receives: Other: Garmin GPS activity tracker |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 6 months post surgery
Oxford Knee
Using the Oxford Knee questionnaire to get the oxford knee score
Measured: pre-surgery
Oxford Knee
Using the Oxford Knee questionnaire to get the oxford knee score
Measured: 6 months post surgery
SF 36 Health survey
SF36 questionnaires to get SF-36 scores
Measured: pre-surgery
SF 36 Health survey
SF36 questionnaires to get SF-36 scores
Measured: 6 months post surgery
Expectation met for surgery
Patient satisfaction form
Measured: pre-surgery
Expectation met for surgery
Patient satisfaction form
Measured: 6 months post surgery
Overall result of surgery
Subject's summary and outcomes form; data collected from Orthopaedic diagnostis center (ODC)
Measured: pre-surgery
Overall result of surgery
Subject's summary and outcomes form; data collected from Orthopaedic diagnostis center (ODC)
Measured: 6 months post surgery
Length of stay
the number of nights spend in the hospital from the day of surgery
Measured: up to 6 months post surgery
Premorbid history
Patients reported ambulation status before surgery, including the use of walking aids and assistance level required
Measured: up to 6 months post surgery
Early ambulation rate
Percentage of patients who start walking postoperative day (POD) 1
Measured: up to 6 months post surgery
Knee range-of-motion
measure knee ROM
Measured: 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
Measured: 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)
Measured: up to 6 months post surgery
Discharge Destination
Where the patient will be going to after discharge from SGH
Measured: 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
Measured: 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
Measured: 6 months post surgery for 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2021
- Study start11 Jun 2018
- Primary completion13 Oct 2022 (estimated)
- Study completion30 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Curtin University
- Responsible party
- Sponsor
- Investigators
- Celia Tan Ia Choo, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05076539
- Sponsor's protocol ID
- Geospatial
- Other IDs
- 2017-2972
- Acronym
- Geospatial
- Status last verified
- Mar 2022
- First submitted
- 20 Sep 2021
- Last updated
- 1 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Quantitative Assessment of Early Mobility in Total Knee Replacement Patients Using Smart Activity Tracker
- ClinicalTrials.gov ID
- NCT05076539
- Acronym / sponsor ID
- Geospatial / Geospatial
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Collaborators
- Curtin University
- Study start
- 11 Jun 2018 (actual)
- Primary completion
- 13 Oct 2022 (estimated)
- Study completion
- 30 Jan 2023 (estimated)
- First posted
- 13 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Geospatial | Other | Other: Garmin GPS activity tracker50 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) |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Garmin GPS activity tracker50 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 | Geospatial |
Primary outcome
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
1. Latitude and longitudinal location coordinates to determine an individual's activity space 2. Distance travelled 3. Walking speed 4. Heart rate 5. Calories burned 6. Energy expenditure 7. Steps count 8. Physical activity
Data Collected from Garmin GPS-activity tracker
Time frame: 6 months post surgery for 1 week
1. Latitude and longitudinal location coordinates to determine an individual's activity space 2. Distance travelled 3. Walking speed 4. Heart rate 5. Calories burned 6. Energy expenditure 7. Steps count 8. Physical activity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yeo Hwee Shan contact
Celia Tan Ia Choo principal investigator
Singapore General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Garmin GPS activity tracker in people with Knee Osteoarthritis, run by Singapore General Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Celia Tan Ia Choo (91721220, celia.tan.i.c@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Society Clinical Rating system (time frame: pre-surgery). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2022.