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

NCT05076539 | Unknown

• 2 other identifiers: Geospatial2017-2972
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (19)

• 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

• 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

• Oxford Knee

  Using the Oxford Knee questionnaire to get the oxford knee score

  pre-surgery

• Oxford Knee

  Using the Oxford Knee questionnaire to get the oxford knee score

  6 months post surgery

• SF 36 Health survey

  SF36 questionnaires to get SF-36 scores

  pre-surgery

• SF 36 Health survey

  SF36 questionnaires to get SF-36 scores

  6 months post surgery

• Expectation met for surgery

  Patient satisfaction form

  pre-surgery

• Expectation met for surgery

  Patient satisfaction form

  6 months post surgery

• Overall result of surgery

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

  pre-surgery

• Overall result of surgery

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

  6 months post surgery

• Length of stay

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

  up to 6 months post surgery

• Premorbid history

  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

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

  up to 6 months post surgery

• Knee range-of-motion

  measure knee ROM

  up to 6 months post surgery

• 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

• 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

• Discharge Destination

  Where the patient will be going to after discharge from SGH

  up to 6 months post surgery

• Data Collected from Garmin GPS-activity tracker

  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

  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

Study Arms (1)

Geospatial

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)

Other: Garmin GPS activity tracker

Interventions

Garmin GPS activity tracker 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).

Geospatial

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Singapore General Hospital: lead
• Curtin University: collaborator

Study Sites (1)

Singapore General Hospital

Singapore, Singapore

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Celia Tan Ia Choo

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Celia Tan Ia Choo

CONTACT

91721220; celia.tan.i.c@singhealth.com.sg

Yeo Hwee Shan

CONTACT

yeo.hwee.shan@sgh.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: October 13, 2021
• Study Start: June 11, 2018
• Primary Completion: October 13, 2022
• Study Completion: January 30, 2023
• Last Updated: April 1, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)