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

Sponsor
Singapore General Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05076539
Collaborator
Curtin University (Other)
50
1
1
55.7
0.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Garmin GPS activity tracker
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
A Quantitative Assessment of Early Mobility in Total Knee Replacement Patients Using Smart Activity Tracker
Actual Study Start Date :
Jun 11, 2018
Anticipated Primary Completion Date :
Oct 13, 2022
Anticipated Study Completion Date :
Jan 30, 2023

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

  1. Knee Society Clinical Rating system [pre-surgery]

    Measuring knee range of motion, knee extension lag, knee alignment in standing using the knee society clinical rating system (KSS Scores)

  2. Knee Society Clinical Rating system [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)

  3. Oxford Knee [pre-surgery]

    Using the Oxford Knee questionnaire to get the oxford knee score

  4. Oxford Knee [6 months post surgery]

    Using the Oxford Knee questionnaire to get the oxford knee score

  5. SF 36 Health survey [pre-surgery]

    SF36 questionnaires to get SF-36 scores

  6. SF 36 Health survey [6 months post surgery]

    SF36 questionnaires to get SF-36 scores

  7. Expectation met for surgery [pre-surgery]

    Patient satisfaction form

  8. Expectation met for surgery [6 months post surgery]

    Patient satisfaction form

  9. Overall result of surgery [pre-surgery]

    Subject's summary and outcomes form; data collected from Orthopaedic diagnostis center (ODC)

  10. Overall result of surgery [6 months post surgery]

    Subject's summary and outcomes form; data collected from Orthopaedic diagnostis center (ODC)

  11. Length of stay [up to 6 months post surgery]

    the number of nights spend in the hospital from the day of surgery

  12. Premorbid history [up to 6 months post surgery]

    Patients reported ambulation status before surgery, including the use of walking aids and assistance level required

  13. Early ambulation rate [up to 6 months post surgery]

    Percentage of patients who start walking postoperative day (POD) 1

  14. Knee range-of-motion [up to 6 months post surgery]

    measure knee ROM

  15. Ability to perform a straight leg raise [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

  16. Type of walking aids used [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)

  17. Discharge Destination [up to 6 months post surgery]

    Where the patient will be going to after discharge from SGH

  18. Data Collected from Garmin GPS-activity tracker [Pre-surgery for 1 week]

    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

  19. Data Collected from Garmin GPS-activity tracker [6 months post surgery for 1 week]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Singapore General Hospital Singapore Singapore

Sponsors and Collaborators

  • Singapore General Hospital
  • Curtin University

Investigators

  • Principal Investigator: Celia Tan Ia Choo, Singapore General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Singapore General Hospital
ClinicalTrials.gov Identifier:
NCT05076539
Other Study ID Numbers:
  • Geospatial
  • 2017-2972
First Posted:
Oct 13, 2021
Last Update Posted:
Apr 1, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 1, 2022