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

Knee Osteoarthritis Clinical Trial

— Geospatial  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05076539
• Other study ID #: Geospatial
• Secondary ID: 2017-2972
• Status: Recruiting
• Phase: N/A
• Start date: June 11, 2018
• Est. completion date: January 30, 2023

Study information

• Verified date: March 2022
• Source: Singapore General Hospital
• Contact: Celia Tan Ia Choo
• Phone: 91721220
• Email: celia.tan.i.c[@]singhealth.com.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 30, 2023
• Est. primary completion date: October 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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).

Locations

Country	Name	City	State
Singapore	Singapore General Hospital	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Singapore General Hospital	Curtin University

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Oxford Knee	Using the Oxford Knee questionnaire to get the oxford knee score	pre-surgery
Primary	Oxford Knee	Using the Oxford Knee questionnaire to get the oxford knee score	6 months post surgery
Primary	SF 36 Health survey	SF36 questionnaires to get SF-36 scores	pre-surgery
Primary	SF 36 Health survey	SF36 questionnaires to get SF-36 scores	6 months post surgery
Primary	Expectation met for surgery	Patient satisfaction form	pre-surgery
Primary	Expectation met for surgery	Patient satisfaction form	6 months post surgery
Primary	Overall result of surgery	Subject's summary and outcomes form; data collected from Orthopaedic diagnostis center (ODC)	pre-surgery
Primary	Overall result of surgery	Subject's summary and outcomes form; data collected from Orthopaedic diagnostis center (ODC)	6 months post surgery
Primary	Length of stay	the number of nights spend in the hospital from the day of surgery	up to 6 months post surgery
Primary	Premorbid history	Patients reported ambulation status before surgery, including the use of walking aids and assistance level required	up to 6 months post surgery
Primary	Early ambulation rate	Percentage of patients who start walking postoperative day (POD) 1	up to 6 months post surgery
Primary	Knee range-of-motion	measure knee ROM	up to 6 months post surgery
Primary	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
Primary	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
Primary	Discharge Destination	Where the patient will be going to after discharge from SGH	up to 6 months post surgery
Primary	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
Primary	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