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

• Sponsor: Stanford University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06080152
• Collaborator: (none)
• Enrollment: 24
• Arms: 2
• Anticipated Duration (Months): 21

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Total Knee Arthroplasty	Device: Mobility Tool	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 24 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention 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 weeksPatient 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)
• Primary Purpose: Supportive Care
• Official Title: Effect of Walker vs Wheeled Device on Mobility After Total Knee Arthroplasty
• Anticipated Study Start Date: Nov 1, 2023
• Anticipated Primary Completion Date: Mar 1, 2025
• Anticipated Study Completion Date: Aug 1, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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

3. 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

4. surgery cancellation [6 months]

   To determine if surgery was cancelled as a result of effectiveness of device

5. Timed up & Go [6 months]

   Calculating Timed up & Go at 6 months visit

6. 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

7. Time with Device [6 months]

   Determining compliance of device usage

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Receiving total knee arthroplasty

Exclusion Criteria:

• Not receiving total knee arthroplasty

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Stanford University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Derek Amanatullah, Associate Professor of Orthopaedic Surgery, Stanford University
• ClinicalTrials.gov Identifier: NCT06080152
• Other Study ID Numbers: 70192
• First Posted: Oct 12, 2023
• Last Update Posted: Oct 12, 2023
• Last Verified: Oct 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Oct 12, 2023