An observational study in Knee Osteoarthristis, Hip Osteoarthritis and Spine Disease, sponsored by University of Chile. Not yet recruiting at 2 sites in Chile. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by University of Chile · Observational
Clinical validation of SMARTDIAGO, an artificial intelligence-based system for remote functional assessment of patients with musculoskeletal disorders and functional frailty. The study will compare remote assessments performed using SMARTDIAGO with standardized in-person clinical evaluations to determine diagnostic accuracy, agreement, and operational feasibility.
This prospective, observational diagnostic validation study aims to evaluate the accuracy and operational feasibility of SMARTDIAGO, a digital platform that uses artificial intelligence and functional video analysis to remotely assess patients with musculoskeletal conditions and functional frailty.
Approximately 350 outpatients referred from primary care services will undergo a remote functional assessment using SMARTDIAGO, followed by an in-person assessment at the hospital and a clinical evaluation by a specialist.
Functional assessments will include the 30-second Sit-to-Stand test, joint range of motion measurements, and questionnaires addressing pain, functional status, and relevant medical history.
Clinicians performing in-person assessments will be blinded to SMARTDIAGO results to minimize assessment bias.
Diagnostic performance will be evaluated using sensitivity, specificity, receiver operating characteristic curves, area under the curve, calibration, and agreement with clinical reference assessments. Operational feasibility will be assessed through execution time, repeated attempts, and user satisfaction.
The study does not involve therapeutic interventions, experimental medications, or changes to usual clinical care.
642 studies on the registry are indexed under Osteoarthritis, Hip; 122 are open to participants now.
This study's planned enrollment of 350 is above the median of 135 across 159 observational studies indexed under Osteoarthritis, Hip.
Browse Osteoarthritis, Hip studies →University of Chile is the lead sponsor of 194 studies on the registry; 38 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population will consist of approximately 350 outpatients aged 55 years or older referred from primary care centers within the Hospital Clínico Universidad de Chile and Servicio de Salud Metropolitano Norte healthcare networks. Participants will include patients with knee or hip osteoarthritis, degenerative spine or shoulder disorders, and older adults aged 60 years or above with functional frailty. All participants will undergo remote functional assessment using SMARTDIAGO, followed by standardized in-person functional and specialist clinical evaluations. Hospitalized patients will not be included.
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
Patients with knee or hip osteoarthritis referred for specialist assessment.
Diagnostic Test: SMARTDIAGO Remote Functional Assessment
Patients with degenerative spine or shoulder conditions referred for specialist assessment.
Diagnostic Test: SMARTDIAGO Remote Functional Assessment
Older adults with functional frailty referred for geriatric assessment
Diagnostic Test: SMARTDIAGO Remote Functional Assessment
SMARTDIAGO is an artificial intelligence-based digital platform designed for remote functional assessment using video-based movement analysis. Participants will perform standardized functional tests, including the 30-second Sit-to-Stand test and joint range of motion assessments, using a smartphone or computer camera. The system will analyze movement and functional performance. Results will be compared with standardized in-person clinical assessments performed by blinded healthcare professionals. SMARTDIAGO will not administer treatment or modify usual clinical care.
Diagnostic Accuracy of SMARTDIAGO (AUC-ROC)
Area under the receiver operating characteristic curve for identifying clinically significant functional impairment or appropriate specialist referral, compared with the standardized clinical reference assessment.
Time frame: From enrollment to the end of assessment at 5 days
Sensitivity and Specificity
Sensitivity and specificity of SMARTDIAGO for identifying clinically significant functional impairment or referral appropriateness.
Time frame: From enrollment to the end of assessment at 5 days
Agreement Between SMARTDIAGO and In-Person Assessment
Agreement between remote functional measurements and standardized in-person clinical assessments.
Time frame: From enrollment to the end of assessment at 5 days
Functional Performance
Number of repetitions completed during the 30-second Sit-to-Stand test.
Time frame: From enrollment to the end of assessment at 5 days
Joint Range of Motion
Joint range of motion assessed in the knee, hip, shoulder, and spine, as applicable.
Time frame: From enrollment to the end of assessment at 5 days
Operational Feasibility
Time required to complete the remote assessment and number of attempts needed.
Time frame: From enrollment to the end of assessment at 5 days
User Satisfaction
Participant-reported ease of use and satisfaction with SMARTDIAGO.
Time frame: From enrollment to the end of assessment at 5 days
Plan to share: Yes
Supporting information: Study protocol, Clinical study report, Analytic code
Access criteria: Qualified researchers may submit a written request to the principal investigator, including the research objectives, proposed analyses, and data protection measures. Access will be subject to scientific review, institutional authorization, and execution of a data use agreement where applicable.
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Sep 2027, 10 months later.
Of 51 non-industry observational studies under Osteoarthritis, Hip, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 59. This study's planned 10 months is below that.
Counting every sponsor, half of 82 studies reached it within 55 months; a quarter within 14 and three quarters within 113.
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 ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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