Effect of Walker vs Wheeled Device on Mobility After Total Knee Arthroplasty

Total Knee Arthroplasty Clinical Trial

Official title:

Effect of Walker vs Wheeled Device on Mobility After Total Knee Arthroplasty

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06080152
• Other study ID #: 70192
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: August 2025

Study information

• Verified date: April 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Maneuverability is currently under appreciated by patients who are seeking mobility. This pilot study is examining how patients maneuverability and mobility will change with this novel mobility tool - A-Linker compared to the standard of care walker.

Description:

Patients who are using a walker is randomized into two groups:

1. 12 patients get an A-linker 3 months before surgery (knee arthroplasty)

2. 12 patients use a walker 3 months before surgery (knee arthroplasty)

All 24 patients will undergo a total knee Arthroplasty surgery.

Questionnaires at:

0 week from randomization into two groups 6 weeks 12 weeks (surgery) 18 weeks

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: August 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Receiving total knee arthroplasty

Exclusion Criteria:

• Not receiving total knee arthroplasty

Related Conditions & MeSH terms

• Total Knee Arthroplasty

Intervention

Device:
• Mobility Tool
An A-Linker device will be given to 12 patients 3 months before their total knee arthroplasty

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mobility after surgery	Mobility will be assess using MyPhD linked wearable device. The software will help us capture-; Steps: # of steps per hour; Walking/Running distance: per hour	6 months
Secondary	Questionnaire Results	Mobility will be assess using MyPhD linked wearable device. The software will help us capture-; Steps: # of steps per hour; Walking/Running distance: per hour	6 months
Secondary	Determining intensity of pain	We plan to use VAS pain scale as measurement scale ( range; 0-10, higher scores correspond to greater pain	6 months
Secondary	Change in knee society score	To assess the effectiveness of the device by calculating Initial knee society score (KSS) and Knee society score at 2 weeks, 3 months and 2 years after surgery. The scale ranges from 0-100 with grading as Score 80-100 - Excellent Score 70-79 - Good Score 60-69 - Fair Score below 60 - Poor	6 months
Secondary	surgery cancellation	To determine if surgery was cancelled as a result of effectiveness of device	6 months
Secondary	Timed up & Go	Calculating Timed up & Go at 6 months visit	6 months
Secondary	Use of gait aide	To assess the effectiveness of the device by examining Gait Aide use at discharge, 2 weeks, 3 months and 2 years after surgery. This is done to examine performance . The gait aide use provident ranges as Nothing > Cane > crutch > walker	6 months
Secondary	Time with Device	Determining compliance of device usage	6 months