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

NCT ID: NCT05076539

Last Updated: 2022-04-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-11
• Study Completion Date: 2023-01-30

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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)

Group Type: OTHER

Garmin GPS activity tracker

Intervention Type: 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).

Interventions

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).

Intervention Type: OTHER

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Curtin University

OTHER

Sponsor Role: collaborator

Singapore General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Celia Tan Ia Choo

Role: PRINCIPAL_INVESTIGATOR

Singapore General Hospital

Locations

Singapore General Hospital

Singapore, , Singapore

Site Status: RECRUITING

Countries

Singapore

Central Contacts

Celia Tan Ia Choo

Role: CONTACT

celia.tan.i.c@singhealth.com.sg

91721220

Yeo Hwee Shan

Role: CONTACT

yeo.hwee.shan@sgh.com.sg

Facility Contacts

Research Office

Role: primary

research.office@sgh.com.sg

Celia Tan Ia Choo

Role: backup

celia.tan.i.c@singhealth.com.sg

Other Identifiers

2017-2972

Identifier Type: OTHER

Identifier Source: secondary_id

Geospatial

Identifier Type: -

Identifier Source: org_study_id