An observational study in Total Knee Arthroplasty, sponsored by Shanghai Jiao Tong University School of Medicine. Enrolling by invitation at 1 site in China. Open to female participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Shanghai Jiao Tong University School of Medicine · Observational
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.
Shanghai Jiao Tong University School of Medicine is the lead sponsor of 370 studies on the registry; 107 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients undergoing knee arthroplasty
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Device: Smartphone Video-Based AI Gait Analysis · Device: video recorded on a mobile phone (assessed by doctors)
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.
After the video is recorded on a mobile phone, a doctor reviews it to analyze the patient's recovery status.
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.
Time frame: 6 and 12 weeks after TKA
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.
Time frame: 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.
Time frame: 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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 12 weeks, through study completion
Started Jan 2026 (actual). Primary completion is estimated for Jan 2027, 12 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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