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

March 30, 2022 updated by: Singapore General Hospital
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
pre-surgery
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)
6 months post surgery
Oxford Knee
Time Frame: pre-surgery
Using the Oxford Knee questionnaire to get the oxford knee score
pre-surgery
Oxford Knee
Time Frame: 6 months post surgery
Using the Oxford Knee questionnaire to get the oxford knee score
6 months post surgery
SF 36 Health survey
Time Frame: pre-surgery
SF36 questionnaires to get SF-36 scores
pre-surgery
SF 36 Health survey
Time Frame: 6 months post surgery
SF36 questionnaires to get SF-36 scores
6 months post surgery
Expectation met for surgery
Time Frame: pre-surgery
Patient satisfaction form
pre-surgery
Expectation met for surgery
Time Frame: 6 months post surgery
Patient satisfaction form
6 months post surgery
Overall result of surgery
Time Frame: pre-surgery
Subject's summary and outcomes form; data collected from Orthopaedic diagnostis center (ODC)
pre-surgery
Overall result of surgery
Time Frame: 6 months post surgery
Subject's summary and outcomes form; data collected from Orthopaedic diagnostis center (ODC)
6 months post surgery
Length of stay
Time Frame: up to 6 months post surgery
the number of nights spend in the hospital from the day of surgery
up to 6 months post 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
up to 6 months post surgery
Early ambulation rate
Time Frame: up to 6 months post surgery
Percentage of patients who start walking postoperative day (POD) 1
up to 6 months post surgery
Knee range-of-motion
Time Frame: up to 6 months post surgery
measure knee ROM
up to 6 months post surgery
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
up to 6 months post surgery
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)
up to 6 months post surgery
Discharge Destination
Time Frame: up to 6 months post surgery
Where the patient will be going to after discharge from SGH
up to 6 months post surgery
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
Pre-surgery for 1 week
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
6 months post surgery for 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Singapore General Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Curtin University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Celia Tan Ia Choo, Singapore General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 11, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 13, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 20, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 13, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 1, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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