Observation of Wheeled Device Use After TKA | NCT06080152

Studies
Observation of Wheeled Device Use After TKA

NCT06080152

Sponsor

Stanford University

Status

Recruiting

Last Update Posted

Mar 17, 2026Actual

Enrollment

19Estimated

Phase

Not Applicable

Conditions

Total Knee Arthroplasty

Interventions

Mobility Tool

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2, 2024Actual

Primary Completion Date

Oct 2027Estimated

Completion Date

Aug 2028Estimated

First Submitted Date

Jul 10, 2023

First Submission Date that Met QC Criteria

Oct 5, 2023

First Posted Date

Oct 12, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 13, 2026

Last Update Posted Date

Mar 17, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Derek Amanatullah, Associate Professor of Orthopaedic Surgery, Stanford UniversityPrincipal Investigator

Lead Sponsor

Stanford UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

19Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	19 patients get an A-linker 1-3 months before surgery (knee arthroplasty)	Device: Mobility Tool

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mobility Tool	Device	An A-Linker device will be given to 12 patients 3 months before their total knee arthroplasty	1

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Derek Amanatullah, MD	Contact	(650) 723-2257		DFA@stanford.edu

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
450 Broadway	Recruiting	Redwood City	California	94063	United States

Intervention Model Description

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.

A maximum of 19 patients will be enrolled and will receive an Alinker prior to surgery at their pre-op clinical visit. The Alinker will be assembled with 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. The participant will answer questionnaires pre-operatively and at 2 weeks, 6 weeks, and 3 months.

Questionnaires at:

Pre-operatively
2 weeks post-operatively
6 weeks post-operatively
12 weeks post-operatively