CClinicalTrials.gg
RecruitingNCT06080152Updated Mar 17, 2026

Observation of Wheeled Device Use After TKA

An interventional study of Mobility Tool in Total Knee Arthroplasty, sponsored by Stanford University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-03-17.

Sponsored by Stanford University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started Oct 2024; still recruiting 2 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
19
Allocation
Not applicable
Ages
18 Years to 99 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Total Knee Arthroplasty
03

In context

Lead sponsor

Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
19 participants (estimated)

Study arms

  • Experimental
    1

    19 patients get an A-linker 1-3 months before surgery (knee arthroplasty)

    Device: Mobility Tool

Interventions

  • DeviceMobility Tool

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months

Secondary outcomes

  1. Determining intensity of pain

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

    Time frame: 6 months

  2. 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

    Time frame: 6 months

  3. surgery cancellation

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

    Time frame: 6 months

  4. 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

    Time frame: 6 months

  5. Time with Device

    Determining compliance of device usage

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
  • 450 Broadway
    Redwood City, California 94063, United States
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06080152
Lead sponsor
Stanford University
Responsible party
Derek Amanatullah (Associate Professor of Orthopaedic Surgery, Stanford University) — Principal investigator
First posted
Oct 12, 2023
Start date
Oct 2, 2024
Primary completion
Oct 2027 (estimated)
Completion
Aug 2028 (estimated)
Last update
Mar 17, 2026

Study contacts

Derek Amanatullah, MD
Contact
DFA@stanford.edu
(650) 723-2257

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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