Clinical trial NCT05076539: A Quantitative Assessment of Early Mobility in Total Knee Replacement Patients Using Smart Activity Tracker
Official title: A Quantitative Assessment of Early Mobility in Total Knee Replacement Patients Using Smart Activity Tracker
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
Collaborators: name: Curtin University
First posted: 2021-10-13
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Knee Society Clinical Rating system
timeFrame: pre-surgery
measure: Knee Society Clinical Rating system
timeFrame: 6 months post surgery
measure: Oxford Knee
timeFrame: pre-surgery
measure: Oxford Knee
timeFrame: 6 months post surgery
measure: SF 36 Health survey
timeFrame: pre-surgery
measure: SF 36 Health survey
timeFrame: 6 months post surgery
measure: Expectation met for surgery
timeFrame: pre-surgery
measure: Expectation met for surgery
timeFrame: 6 months post surgery
measure: Overall result of surgery
timeFrame: pre-surgery
measure: Overall result of surgery
timeFrame: 6 months post surgery
measure: Length of stay
timeFrame: up to 6 months post surgery
measure: Premorbid history
timeFrame: up to 6 months post surgery
measure: Early ambulation rate
timeFrame: up to 6 months post surgery
measure: Knee range-of-motion
timeFrame: up to 6 months post surgery
measure: Ability to perform a straight leg raise
timeFrame: up to 6 months post surgery
measure: Type of walking aids used
timeFrame: up to 6 months post surgery
measure: Discharge Destination
timeFrame: up to 6 months post surgery
measure: Data Collected from Garmin GPS-activity tracker
timeFrame: Pre-surgery for 1 week
measure: Data Collected from Garmin GPS-activity tracker
timeFrame: 6 months post surgery for 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
affiliation: Singapore General Hospital
name: Celia Tan Ia Choo
role: PRINCIPAL_INVESTIGATOR
References: