Total Knee ArthroplastyNCT06080152
Observation of Wheeled Device Use After TKA
A study testing Mobility Tool in people with Total Knee Arthroplasty, run by Stanford University at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Mobility Tool
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2024to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any person receiving Primary Total Knee Arthroplasty, ages 18-99
- Patient is mobile with no more than a single cane/single crutch assist preoperatively
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
450 Broadway
Redwood City, California, 94063
Angela Bye CRC, MA, abye@stanford.edu
Agnes Ith Associate Director of Research, 650-721-7600, mith@stanford.edu
About this study
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.
- Conditions
- Total Knee Arthroplasty
- Being tested
- Mobility Tool
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobility ToolDevice
An A-Linker device will be given to 12 patients 3 months before their total knee arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 19 patients get an A-linker 1-3 months before surgery (knee arthroplasty) Receives: Device: Mobility Tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (5)
Determining intensity of pain
We plan to use VAS pain scale as measurement scale ( range; 0-10, higher scores correspond to greater pain
Measured: 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
Measured: 6 months
surgery cancellation
To determine if surgery was cancelled as a result of effectiveness of device
Measured: 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
Measured: 6 months
Time with Device
Determining compliance of device usage
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start2 Oct 2024
- Primary completionOct 2027 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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
- Masking
- None (open label)
- Enrolment
- 19 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Derek Amanatullah, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06080152
- Sponsor's protocol ID
- 70192
- Status last verified
- Mar 2026
- First submitted
- 10 Jul 2023
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation of Wheeled Device Use After TKA
- ClinicalTrials.gov ID
- NCT06080152
- Acronym / sponsor ID
- 70192
- Conditions
- Total Knee Arthroplasty
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 19 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 2 Oct 2024 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 12 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Mobility Tool19 patients get an A-linker 1-3 months before surgery (knee arthroplasty) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Any person receiving Primary Total Knee Arthroplasty, ages 18-99
- Patient is mobile with no more than a single cane/single crutch assist preoperatively
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobility ToolAn A-Linker device will be given to 12 patients 3 months before their total knee arthroplasty | Device | 1 |
Primary outcome
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.
5 secondary outcomes
Determining intensity of pain
Time frame: 6 months
Change in knee society score
Time frame: 6 months
surgery cancellation
Time frame: 6 months
Use of gait aide
Time frame: 6 months
Time with Device
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
Related trials for Total Knee Arthroplasty
RecruitingPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Venous Thromboembolism (VTE)
Recruiting
SII Levels Following iPACK Block With Adductor Canal Block in Knee Arthroplasty
Knee Osteoarthritis
Enrolling by invitationObservational study
Persona SoluTion PPS Femur PMCF
Rhematoid Arthritis, Osteo Arthritis of the Knee
Recruiting
ACB and iPACK Blocks With Intravenous Dexamethasone and Perineural Dexmedetomidine in Total Knee Arthroplasty
Knee Osteoarthritis
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobility Tool in people with Total Knee Arthroplasty, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Derek Amanatullah, MD ((650) 723-2257, DFA@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mobility after surgery (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.