Total Knee ArthroplastyNCT07892248
Smartphone Video-Based AI Gait Analysis Reports to Support Remote Follow-up After Total Knee Arthroplasty
An observational study of Total Knee Arthroplasty, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
This study evaluates whether an artificial intelligence (AI)-assisted gait report generated from smartphone walking videos can support remote follow-up after total knee arthroplasty (TKA). Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Smartphone Video-Based AI Gait Analysis and video recorded on a mobile phone (assessed by doctors)
- Type of treatment
- Medical device
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 1 Feb 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing knee arthroplasty
Who may be able to join
- Age ≥18 years; cclinically diagnosed with knee osteoarthritis (KOA) and scheduled for knee surgery;
- Able to walk safely for short distances without assistance or daily assistive devices;
- Able to use a smartphone, or able to record videos and view reports with the assistance of a caregiver;
- Able to understand the study instructions and complete the questionnaires.
Who cannot join
- Presence of clinical red flags requiring immediate surgery;
- Presence of other conditions significantly affecting gait, severe hip disease, or recent lower-limb fractures;
- Severe cognitive, visual, or speech impairments preventing independent understanding of the study materials;
- Inability to safely complete the standardized walking video recording.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200140
About this study
Official title: Smartphone Video-Based AI Gait Analysis Report to Assist Remote Follow-up After Total Knee Arthroplasty
This study evaluates whether an artificial intelligence (AI)-assisted gait report generated from smartphone walking videos can support remote follow-up after total knee arthroplasty (TKA).
Patients complete standardized walking video recordings and symptom assessments before surgery and at approximately 6 and 12 weeks after surgery. The system analyzes the videos and provides gait information, including walking speed, step characteristics, gait symmetry, gait phases, knee movement, and changes over time.
Read more
A separate clinician evaluation examines whether these AI-generated gait reports improve remote clinical decision-making. Clinicians review postoperative cases using either usual remote information, including patient-reported symptoms and the original walking video, or the same information supplemented with the AI-generated gait report. The study evaluates the clinical acceptability of management recommendations, agreement with in-person clinical assessments, clinician confidence, need for additional information, and decision time.
The study also evaluates the feasibility, usability, and trust associated with home-based smartphone gait assessment from both patient and clinician perspectives. The AI gait report is intended to support postoperative monitoring and communication and does not replace clinical diagnosis or scheduled in-person follow-up.
- Conditions
- Total Knee Arthroplasty
- Being tested
- Smartphone Video-Based AI Gait Analysis, video recorded on a mobile phone (assessed by doctors)
- Keywords
- Total Knee Arthroplasty, application, AI Gait Analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone Video-Based AI Gait AnalysisDevice
After the video is recorded on a mobile phone, AI analyzes it to assess the patient's rehabilitation status. This is not an intervention; it is solely for observing the status of rehabilitation progress prior to the follow-up visit.
video recorded on a mobile phone (assessed by doctors)Device
After the video is recorded on a mobile phone, a doctor reviews it to analyze the patient's recovery status.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing knee replacement | Not described Receives: Device: Smartphone Video-Based AI Gait Analysis; Device: video recorded on a mobile phone (assessed by doctors) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and proportion of physician-case remote management recommendations classified as clinically acceptable compared with the in-person reference assessment
At postoperative weeks 6 and 12, participating physicians review deidentified remote follow-up cases and provide a management recommendation. An independent senior orthopedic physician who is not involved in the remote case evaluation determines the clinically acceptable management option or range of options for each patient-timepoint case based on the concurrent in-person clinical assessment and available imaging information. Each physician-case recommendation is classified as clinically acceptable if it falls within the reference range and clinically unacceptable otherwise. The outcome is reported as the number and proportion of clinically acceptable physician-case evaluations among all valid evaluations in each study condition.
Measured: 6 and 12 weeks after TKA
Secondary outcomes (7)
Number and proportion of physician recovery-status assessments agreeing with the concurrent in-person reference assessment
Physicians classify the patient's recovery status as improved, stable, worsened, or unable to determine. For each patient-timepoint case, the physician's recovery-status assessment is compared with the recovery status established from the concurrent in-person clinical assessment. The outcome is reported as the number and proportion of physician-case assessments that agree with the in-person reference assessment in each study condition.
Measured: 6 and 12 weeks after TKA
Mean physician confidence score for remote management recommendations rated on a 0-100 scale
After providing a management recommendation for each case, physicians rate their confidence that the recommendation would be supported by the concurrent in-person clinical assessment on a scale from 0 to 100, with higher scores indicating greater confidence. The outcome is summarized as the mean confidence score for physician-case evaluations in each study condition.
Measured: 6 and 12 weeks after TKA
Number and proportion of physician-case assessments in which recovery status cannot be determined
Physicians classify recovery status as improved, stable, worsened, or unable to determine. The outcome is reported as the number and proportion of valid physician-case evaluations for which "unable to determine" is selected in each study condition.
Measured: 6 and 12 weeks after TKA
Number and proportion of physician-case assessments in which a management recommendation cannot be provided because of insufficient information
For each case, physicians provide a management recommendation or indicate that a recommendation cannot be made because the available information is insufficient. The outcome is reported as the number and proportion of valid physician-case evaluations in which no management recommendation can be provided because of insufficient information.
Measured: 6 and 12 weeks after TKA
Mean time in seconds required to complete each physician-case evaluation
The study system automatically records the time required for a physician to review the available case information and complete the required recovery-status assessment and management recommendation. Decision time is reported in seconds and summarized for each study condition.
Measured: 6 and 12 weeks after TKA
Mean Mobile Application Usability Questionnaire score among patients using the smartphone gait assessment system
At the end of the postoperative follow-up period, patients complete the Chinese version of the Mobile Application Usability Questionnaire (C-MAUQ) to evaluate the usability of the smartphone-based gait assessment system, including ease of use and satisfaction, system information arrangement, and perceived usefulness. The total score and domain scores are summarized using descriptive statistics. Under the scoring direction used in this study, lower scores indicate more favorable usability.
Measured: Up to 12 weeks, through study completion
Mean Health Information Technology Usability Evaluation Scale score among participating physicians
After completing all case evaluations, physicians who used the AI-assisted gait report complete the Chinese professional version of the Health Information Technology Usability Evaluation Scale (Health-ITUES-P). The questionnaire assesses perceived usefulness, ease of use, user control, and compatibility with clinical workflow. Total and domain scores are summarized descriptively. Scores range from 1 to 5, with higher scores indicating a more favorable usability evaluation.
Measured: Up to 12 weeks, through study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start1 Jan 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Feb 2027 (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.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 36 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhu Dian, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07892248
- Sponsor's protocol ID
- MDH003
- Status last verified
- Nov 2025
- First submitted
- 5 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartphone Video-Based AI Gait Analysis Report to Assist Remote Follow-up After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT07892248
- Acronym / sponsor ID
- MDH003
- Conditions
- Total Knee Arthroplasty
- Keywords
- Total Knee Arthroplasty, application, AI Gait Analysis
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 23 Oct 2026 (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.
This study evaluates whether an artificial intelligence (AI)-assisted gait report generated from smartphone walking videos can support remote follow-up after total knee arthroplasty (TKA).
Patients complete standardized walking video recordings and symptom assessments before surgery and at approximately 6 and 12 weeks after surgery. The system analyzes the videos and provides gait information, including walking speed, step characteristics, gait symmetry, gait phases, knee movement, and changes over time.
A separate clinician evaluation examines whether these AI-generated gait reports improve remote clinical decision-making. Clinicians review postoperative cases using either usual remote information, including patient-reported symptoms and the original walking video, or the same information supplemented with the AI-generated gait report. The study evaluates the clinical acceptability of management recommendations, agreement with in-person clinical assessments, clinician confidence, need for additional information, and decision time.
The study also evaluates the feasibility, usability, and trust associated with home-based smartphone gait assessment from both patient and clinician perspectives. The AI gait report is intended to support postoperative monitoring and communication and does not replace clinical diagnosis or scheduled in-person follow-up.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing knee replacement | – | Device: Smartphone Video-Based AI Gait Analysis, Device: video recorded on a mobile phone (assessed by doctors) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing knee arthroplasty
Key inclusion criteria (4 listed)
- Age ≥18 years; cclinically diagnosed with knee osteoarthritis (KOA) and scheduled for knee surgery;
- Able to walk safely for short distances without assistance or daily assistive devices;
- Able to use a smartphone, or able to record videos and view reports with the assistance of a caregiver;
- Able to understand the study instructions and complete the questionnaires.
Key exclusion criteria (4 listed)
- Presence of clinical red flags requiring immediate surgery;
- Presence of other conditions significantly affecting gait, severe hip disease, or recent lower-limb fractures;
- Severe cognitive, visual, or speech impairments preventing independent understanding of the study materials;
- Inability to safely complete the standardized walking video recording.
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 |
|---|---|---|
| Smartphone Video-Based AI Gait AnalysisAfter the video is recorded on a mobile phone, AI analyzes it to assess the patient's rehabilitation status. This is not an intervention; it is solely for observing the status of rehabilitation progress prior to the follow-up visit. | Device | Patients undergoing knee replacement |
| video recorded on a mobile phone (assessed by doctors)After the video is recorded on a mobile phone, a doctor reviews it to analyze the patient's recovery status. | Device | Patients undergoing knee replacement |
Primary outcome
Number and proportion of physician-case remote management recommendations classified as clinically acceptable compared with the in-person reference assessment
Time frame: 6 and 12 weeks after TKA
At postoperative weeks 6 and 12, participating physicians review deidentified remote follow-up cases and provide a management recommendation. An independent senior orthopedic physician who is not involved in the remote case evaluation determines the clinically acceptable management option or range of options for each patient-timepoint case based on the concurrent in-person clinical assessment and available imaging information. Each physician-case recommendation is classified as clinically acceptable if it falls within the reference range and clinically unacceptable otherwise. The outcome is reported as the number and proportion of clinically acceptable physician-case evaluations among all valid evaluations in each study condition.
7 secondary outcomes
Number and proportion of physician recovery-status assessments agreeing with the concurrent in-person reference assessment
Time frame: 6 and 12 weeks after TKA
Mean physician confidence score for remote management recommendations rated on a 0-100 scale
Time frame: 6 and 12 weeks after TKA
Number and proportion of physician-case assessments in which recovery status cannot be determined
Time frame: 6 and 12 weeks after TKA
Number and proportion of physician-case assessments in which a management recommendation cannot be provided because of insufficient information
Time frame: 6 and 12 weeks after TKA
Mean time in seconds required to complete each physician-case evaluation
Time frame: 6 and 12 weeks after TKA
Mean Mobile Application Usability Questionnaire score among patients using the smartphone gait assessment system
Time frame: Up to 12 weeks, through study completion
Mean Health Information Technology Usability Evaluation Scale score among participating physicians
Time frame: Up to 12 weeks, through study completion
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 23 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Knee Arthroplasty, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
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 4 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 23 Oct 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 China. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and proportion of physician-case remote management recommendations classified as clinically acceptable compared with the in-person reference assessment (time frame: 6 and 12 weeks after TKA). 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 23 Oct 2026.