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

Not Applicable

Recruiting

• Conditions: Total Knee Arthroplasty

• Registration Number: NCT06080152
• Lead Sponsor: Stanford University

Brief 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.

Detailed 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

Study Timeline

• Study First Submitted: 2023-07-10
• Study First Submitted QC: 2023-10-05
• Study First Posted: 2023-10-12
• Study Start: 2024-10-02
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-08
• Last Update Posted: 2025-04-11
• Primary Completion: 2027-10
• Study Completion: 2028-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Receiving total knee arthroplasty

Exclusion Criteria

• Not receiving total knee arthroplasty

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mobility after surgery	6 months	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

Secondary Outcome Measures

Name	Time	Method
Timed up & Go	6 months	Calculating Timed up \& Go at 6 months visit
Questionnaire Results	6 months	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
Change in knee society score	6 months	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
surgery cancellation	6 months	To determine if surgery was cancelled as a result of effectiveness of device
Use of gait aide	6 months	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
Determining intensity of pain	6 months	We plan to use VAS pain scale as measurement scale ( range; 0-10, higher scores correspond to greater pain
Time with Device	6 months	Determining compliance of device usage

Trial Locations

Locations (1)

450 Broadway; 🇺🇸 Redwood City, California, United States