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NCT07833605

AI-Based Video Assessment of Anterior Knee Laxity

Sponsor: ASL Lecce

View on ClinicalTrials.gov

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.

Official title: Artificial Intelligence-Based Video Assessment of Anterior Knee Laxity Compared With Rolimeter in Patients With Anterior Cruciate Ligament Injury: A Prospective Validation Study

Key Details

Gender

All

Age Range

16 Years - 55 Years

Study Type

OBSERVATIONAL

Enrollment

70

Start Date

2026-09-15

Completion Date

2026-12-31

Last Updated

2026-09-22

Healthy Volunteers

Yes

Locations (1)

Ospedale Vito Fazzi

Lecce, Italy