Observation of Wheeled Device Use After TKA

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.

Study Overview

• Status: Recruiting
• Conditions: Total Knee Arthroplasty
• Intervention / Treatment: Device: Mobility Tool

Detailed Description

Individuals living with challenges that affect their mobility may lead to loss of independence, loss of activity and engagement with life. We are seeking individuals who are having a Total Knee Replacement and are seeking increased mobility using the Alinker, which is a non-motorized walking bike without pedals.

Each participant will receive the Alinker prior to surgery, and will be encouraged to use it as much as possible before surgery and during the 3-month post-operative period.

• Study Type: Interventional
• Enrollment (Estimated): 19
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Derek Amanatullah, MD; Phone Number: (650) 723-2257; Email: DFA@stanford.edu

Study Locations

• United States
  • California
    • Redwood City, California, United States, 94063
      • Recruiting
      • 450 Broadway
      • Contact: Angela Bye CRC, MA; Email: abye@stanford.edu
      • Contact: Agnes Ith Associate Director of Research; Phone Number: 650-721-7600; Email: mith@stanford.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Any person receiving Primary Total Knee Arthroplasty, ages 18-99
• Patient is mobile with no more than a single cane/single crutch assist preoperatively

Exclusion Criteria:

• Any person not receiving knee arthroplasty, ages under 18 or greater than 99
• Patient requires simultaneous or staged bilateral replacements, staged <90 days apart.
• Patients who have active claudication from a lumbar stenosis or peripheral vascular disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; 19 patients get an A-linker 1-3 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mobility after surgery	Mobility will be assessed by using a bicycle odometer to track usage and mobility. The odometer will be checked 2 weeks, 6 weeks, and 3 months after surgery during a post-op clinical exam.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: July 10, 2023
• First Submitted That Met QC Criteria: October 5, 2023
• First Posted (Actual): October 12, 2023

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 70192

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No