Artificial Intelligence-Based Video Assessment of Anterior Knee Laxity Compared With Rolimeter in Patients With Anterior Cruciate Ligament Injury: A Prospective Validation Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- ASL Lecce
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Agreement Between AI-Derived and Arthrometer-Derived Side-to-Side Difference in Anterior Tibial Translation
研究概览
简要总结
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.
详细描述
Each examiner will perform three consecutive Rolimeter measurements on both knees. Individual maneuvers will be video recorded so that the Rolimeter and AI measurements refer to the same mechanical examination. Videos will be pseudonymized and analyzed independently. The AI system will have no access to participant group allocation, MRI findings, injured side, Rolimeter measurements, or results from other videos belonging to the same participant.
A standardized metric reference positioned in the plane of the examined knee will be visible in each recording to permit estimation of displacement in millimeters. AI measurements will not be used for clinical decision-making.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
- •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.
研究组 & 干预措施
ACL-deficient participants
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.
ACL-Intact Control Group
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.
结局指标
主要结局
Agreement Between AI-Derived and Arthrometer-Derived Side-to-Side Difference in Anterior Tibial Translation
时间窗: 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.
次要结局
- 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))
研究者
Jacopo Conteduca
Principal Investigator
ASL Lecce