AI-LAX
Artificial Intelligence-Based Video Assessment of Anterior Knee Laxity Compared With Rolimeter in Patients With Anterior Cruciate Ligament Injury: A Prospective Validation Study
Sponsor study identifier
observational
70
1 country
1
Study Start
September 15, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 12, 2026
Actual (reported)September 15, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 22, 2026
Actual (reported)December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Agreement Between AI-Derived and Arthrometer-Derived Side-to-Side Difference in Anterior Tibial Translation
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.
Day 1 (index study examination)
Measurement Error of AI-Derived Anterior Tibial Translation Compared With Arthrometer Measurements
Day 1 (index study examination)
Inter-Examiner Reliability of Arthrometer Measurements
Day 1 (index study examination)
Agreement Between AI Measurements Derived From Examinations Performed by Different Examiners
Day 1 (index study examination)
Diagnostic Accuracy of AI-Derived Side-to-Side Difference for ACL Injury
Day 1 (index study examination)
diagnostic Accuracy of Arthrometer-Derived Side-to-Side Difference for ACL Injury
Day 1 (index study examination)
Adults with a unilateral, complete anterior cruciate ligament (ACL) injury confirmed by magnetic resonance imaging (MRI). Participants will undergo bilateral anterior knee laxity assessment using a Rolimeter by two independent orthopedic examiners. Three consecutive measurements will be obtained for each knee and examiner, and each examination maneuver will be video recorded for subsequent blinded AI-based analysis. The contralateral knee will serve as the within-subject reference for calculation of the side-to-side difference.
Adults without a history or clinical evidence of ACL injury or knee instability. Participants will undergo the same standardized bilateral anterior knee laxity assessment performed by two independent orthopedic examiners using a Rolimeter, with three consecutive measurements for each knee and examiner. Each examination maneuver will be video recorded and subsequently analyzed by the AI system using the same protocol applied to the ACL-deficient cohort.
Adults undergoing prospective bilateral assessment of anterior knee laxity at a single orthopedic center. The study population will include two cohorts: participants with a unilateral, complete anterior cruciate ligament (ACL) injury confirmed by magnetic resonance imaging and ACL-intact control participants without clinical evidence or history of ACL injury. All participants will undergo the same standardized bilateral knee examination using an arthrometer performed independently by two orthopedic examiners. Each examination maneuver will be video recorded for subsequent blinded AI-based assessment of anterior tibial translation.
Ospedale Vito Fazzi
Lecce, 73100, Italy
First Submitted
September 12, 2026
First Posted
September 22, 2026
Study Start
September 15, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 31, 2026
Tourniquet Use in Anterior Cruciate Ligament Repair
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 22, 2026
Record last verified: 2026-09
De-identified data may be made available from the corresponding author upon reasonable request, subject to institutional and ethical approval.
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