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

Study Overview
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Brief Summary
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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
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Patients who are using a walker is randomized into two groups: 12 patients get an A-linker 3 months before surgery (knee arthroplasty) 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

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

Conditions
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Total Knee Arthroplasty

Intervention / Treatment
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* Device: Mobility Tool


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Receiving total knee arthroplasty Exclusion Criteria: Not receiving total knee arthroplasty

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patient who is using a walker is randomized into two groups: 12 patients get an A-linker 3 months before surgery (knee arthroplasty) 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>1. 12 patients get an A-linker 3 months before surgery (knee arthroplasty) | Device: Mobility Tool<br>* An A-Linker device will be given to 12 patients 3 months before their total knee arthroplasty<br>|
| No Intervention: 2<br>2. 12 patients use a walker 3 months before surgery (knee arthroplasty) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| surgery cancellation | To determine if surgery was cancelled as a result of effectiveness of device | 6 months | 
| Timed up & Go | Calculating Timed up & Go at 6 months visit | 6 months | 
| 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 | 
| Time with Device | Determining compliance of device usage | 6 months |