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NCT Number: NCT06080152

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.

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Key information

Conditions

Total Knee Arthroplasty

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mobility Tool

Device

An A-Linker device will be given to 12 patients 3 months before their total knee arthroplasty

Primary outcomes

  1. Mobility after surgery

    Time frame: 6 months

    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.

Secondary outcomes

  1. Determining intensity of pain

    Time frame: 6 months

    We plan to use VAS pain scale as measurement scale ( range; 0-10, higher scores correspond to greater pain

  2. Change in knee society score

    Time frame: 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

  3. surgery cancellation

    Time frame: 6 months

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

  4. Use of gait aide

    Time frame: 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

  5. Time with Device

    Time frame: 6 months

    Determining compliance of device usage

Study contacts

Contact information is provided by the study sponsor or research team.

Derek Amanatullah, MD

CONTACT

[email protected]

(650) 723-2257

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Oct 12, 2023
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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