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Clinical Trials in Italy / NCT07833605
Starting soon Observational

AI-Based Video Assessment of Anterior Knee Laxity

NCT07833605 · tracked via the Priya Life Science Italy tracker
Sponsor
ASL Lecce
Phase
Observational
Started
2026-09-15
Last updated
2026-09-22

Condition(s) studied

ACL - Anterior Cruciate Ligament Deficiency

Study summary

This prospective observational validation study aims to evaluate the accuracy and reliability of artificial intelligence-based video analysis for quantifying anterior knee laxity. Participants with unilateral anterior cruciate ligament (ACL) injury and ACL-intact controls will undergo bilateral knee examination using a Rolimeter by two independent orthopedic surgeons. Three consecutive measurements will be obtained for each knee and examiner. Each examination maneuver will be video recorded using a standardized acquisition protocol including a metric reference of known dimensions.

The videos will subsequently be analyzed independently by a multimodal artificial intelligence system blinded to clinical diagnosis, MRI findings, injured side, examiner measurements, and contralateral knee measurements. AI-derived anterior tibial translation and side-to-side difference will be compared with Rolimeter measurements. The primary objective is to assess agreement between AI-derived and Rolimeter-derived side-to-side difference. Secondary objectives include inter-examiner reliability, AI repeatability and the diagnostic accuracy of AI-derived measurements for identifying ACL injury.

Eligibility

Sex
ALL
Min age
16 Years
Max age
55 Years
Healthy volunteers
Accepted
Inclusion Criteria: * General inclusion criteria * Age ≥16 years. * Ability to understand the study procedures and provide written informed consent. * Ability to undergo bilateral clinical assessment of anterior knee laxity. ACL-Deficient Group * Unilateral complete anterior cruciate ligament (ACL) injury confirmed by magnetic resonance imaging (MRI). * Clinical evidence of anterior knee instability compatible with ACL deficiency. * Contralateral knee without known ACL injury or previous ACL reconstruction. * ACL-Intact Control Group * No history of ACL injury or ACL reconstruction in either knee. * No clinical evidence of anterior knee instability. * Negative clinical assessment for ACL deficiency in both knees. Exclusion Criteria * Previous ACL reconstruction or other major ligament reconstruction of either knee. * Bilateral ACL injury. * Revision ACL injury or previous ACL surgery. * Concomitant complete injury of another major knee ligament requiring surgical treatment. * Previous major knee surgery that could affect anterior tibial translation. * Moderate-to-severe knee osteoarthritis or radiographic osteoarthritis greater than Kellgren-Lawrence grade 1. * Acute fracture involving the examined lower limb. * Neurological, neuromuscular, or other conditions that could interfere with standardized knee examination. * Inability to tolerate or complete the standardized arthrometer examination. * Inability or unwillingness to provide informed consent or consent for study video recording.

Primary outcome measure(s)

  • Agreement Between AI-Derived and Arthrometer-Derived Side-to-Side Difference in Anterior Tibial Translation — Day 1 (index study examination)
    Agreement between the side-to-side difference (SSD, mm) in anterior tibial translation estimated by artificial intelligence from standardized knee examination videos and the corresponding SSD obtained with an arthrometer. Agreement will be assessed using intraclass correlation coefficient (ICC, absolute agreement) and Bland-Altman analysis, including mean bias and 95% limits of agreement.

Trial sites (1)

FacilityCityRegionStatus
Ospedale Vito Fazzi Lecce Italy

More ASL Lecce trials in Italy

Surgeon Physiologic Stress During Unicompartmental Knee Arthroplasty: Manual vs Computer-Assisted Technique Starting soon
Intraoperative Energy Expenditure During ACL Reconstruction Surgery Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07833605 on ClinicalTrials.gov ↗ ← All trials in Italy