Knee OsteoarthristisSMARTDIAGONCT07880210
Clinical Validation of SMARTDIAGO for Remote Functional Assessment of Musculoskeletal Conditions
An observational study of Knee Osteoarthristis and Hip Osteoarthritis, run by University of Chile at 2 sites in Chile.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Knee Osteoarthristis, Hip Osteoarthritis, Spine Disease
- What is being tested?
- SMARTDIAGO Remote Functional Assessment
- How many people
- 350 participants
- Where
- 2 sitesChile
- Study dates
- 2 Nov 2026to 2 Sep 2027
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Age 55 years or older.
- Referral from primary care for knee, hip, shoulder, or spine disorders, or age 60 years or older with functional frailty.
- Access to a smartphone or computer with a camera.
- Ability to perform simple functional movements, including sitting down and standing up from a chair.
Who cannot join
- Uncontrolled neurological or cardiopulmonary conditions.
- Severe pain at rest (greater than 7/10).
- Recent surgery within the previous three months.
- Mild cognitive impairment with insufficient social support, or moderate-to-severe cognitive impairment.
- Pregnancy.
- Simultaneous participation in another clinical research study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Chile2 sites
Hospital Clinico Universidad de Chile
Santiago, Independencia
Maximiliano Barahona, MD, +56999791493, mbarahona@hcuch.cl
Hospital San Jose
Santiago, Independencia
About this study
Official title: Clinical Validation of the SMARTDIAGO System: A Remote Diagnostic Tool for Musculoskeletal Disorders Using Artificial Intelligence and Functional Video Analysis
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.
Read the detailed description
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.
- Being tested
- SMARTDIAGO Remote Functional Assessment
- Keywords
- smartdiago, Artificial Intelligence, Remote Functional Assessment, Diagnostic Accuracy, Musculoskeletal Disorders, Computer Vision, Telemedicine, Functional Mobility, Clinical Validation
- Medical subject headings
- Osteoarthritis, Hip, Spinal Diseases, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMARTDIAGO Remote Functional AssessmentDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Lower Limb Musculoskeletal Disorders | Patients with knee or hip osteoarthritis referred for specialist assessment. Receives: Diagnostic Test: SMARTDIAGO Remote Functional Assessment | |
| Trunk and Upper Limb Disorders | Patients with degenerative spine or shoulder conditions referred for specialist assessment. Receives: Diagnostic Test: SMARTDIAGO Remote Functional Assessment | |
| Geriatric Functional Frailty | Older adults with functional frailty referred for geriatric assessment Receives: Diagnostic Test: SMARTDIAGO Remote Functional Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of assessment at 5 days
Secondary outcomes (6)
Sensitivity and Specificity
Sensitivity and specificity of SMARTDIAGO for identifying clinically significant functional impairment or referral appropriateness.
Measured: 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.
Measured: From enrollment to the end of assessment at 5 days
Functional Performance
Number of repetitions completed during the 30-second Sit-to-Stand test.
Measured: 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.
Measured: From enrollment to the end of assessment at 5 days
Operational Feasibility
Time required to complete the remote assessment and number of attempts needed.
Measured: From enrollment to the end of assessment at 5 days
User Satisfaction
Participant-reported ease of use and satisfaction with SMARTDIAGO.
Measured: From enrollment to the end of assessment at 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start2 Nov 2026 (estimated)
- Primary completion2 Sep 2027 (estimated)
- Study completion2 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthristisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital San José, Chile
- Responsible party
- Principal investigator, maximiliano barahona vasquez, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07880210
- Sponsor's protocol ID
- Acta 085-2025
- Other IDs
- IT25|0174
- Acronym
- SMARTDIAGO
- Status last verified
- Oct 2026
- First submitted
- 11 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of the SMARTDIAGO System: A Remote Diagnostic Tool for Musculoskeletal Disorders Using Artificial Intelligence and Functional Video Analysis
- ClinicalTrials.gov ID
- NCT07880210
- Acronym / sponsor ID
- SMARTDIAGO / Acta 085-2025
- Keywords
- smartdiago, Artificial Intelligence, Remote Functional Assessment, Diagnostic Accuracy, Musculoskeletal Disorders, Computer Vision, Telemedicine, Functional Mobility
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Collaborators
- Hospital San José, Chile
- Study start
- 2 Nov 2026 (estimated)
- Primary completion
- 2 Sep 2027 (estimated)
- Study completion
- 2 Sep 2027 (estimated)
- First posted
- 19 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.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lower Limb Musculoskeletal Disorders | – | Diagnostic Test: SMARTDIAGO Remote Functional AssessmentPatients with knee or hip osteoarthritis referred for specialist assessment. |
| Trunk and Upper Limb Disorders | – | Diagnostic Test: SMARTDIAGO Remote Functional AssessmentPatients with degenerative spine or shoulder conditions referred for specialist assessment. |
| Geriatric Functional Frailty | – | Diagnostic Test: SMARTDIAGO Remote Functional AssessmentOlder adults with functional frailty referred for geriatric assessment |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- Age 55 years or older.
- Referral from primary care for knee, hip, shoulder, or spine disorders, or age 60 years or older with functional frailty.
- Access to a smartphone or computer with a camera.
- Ability to perform simple functional movements, including sitting down and standing up from a chair.
Key exclusion criteria (6 listed)
- Uncontrolled neurological or cardiopulmonary conditions.
- Severe pain at rest (greater than 7/10).
- Recent surgery within the previous three months.
- Mild cognitive impairment with insufficient social support, or moderate-to-severe cognitive impairment.
- Pregnancy.
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 |
|---|---|---|
| SMARTDIAGO Remote Functional AssessmentSMARTDIAGO 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 test | Geriatric Functional Frailty, Lower Limb Musculoskeletal Disorders, Trunk and Upper Limb Disorders |
Primary outcome
Diagnostic Accuracy of SMARTDIAGO (AUC-ROC)
Time frame: From enrollment to the end of assessment at 5 days
Area under the receiver operating characteristic curve for identifying clinically significant functional impairment or appropriate specialist referral, compared with the standardized clinical reference assessment.
6 secondary outcomes
Sensitivity and Specificity
Time frame: From enrollment to the end of assessment at 5 days
Agreement Between SMARTDIAGO and In-Person Assessment
Time frame: From enrollment to the end of assessment at 5 days
Functional Performance
Time frame: From enrollment to the end of assessment at 5 days
Joint Range of Motion
Time frame: From enrollment to the end of assessment at 5 days
Operational Feasibility
Time frame: From enrollment to the end of assessment at 5 days
User Satisfaction
Time frame: From enrollment to the end of assessment at 5 days
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 19 Oct 2026.
- Individual participant dataSharing planned: Yes
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthristis and Hip Osteoarthritis, run by University of Chile at 2 sites in Chile.
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 6 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: opening soon, as of the sponsor's last update on 19 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 2 sites in Chile. 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 Mauricio Cerda (+56985927543, mauricio.cerda@uchile.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy of SMARTDIAGO (AUC-ROC) (time frame: From enrollment to the end of assessment at 5 days). 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 19 Oct 2026.