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AI-Based Video Assessment of Anterior Knee Laxity (AI-LAX)

2026年9月17日 更新者：Jacopo Conteduca、ASL Lecce

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

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.

調査の概要

状態

まだ募集していません

条件

詳細な説明

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.

研究の種類

観察的

入学 (推定)

70

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • イタリア
      • Lecce、イタリア、73100
        • Ospedale Vito Fazzi
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

16年～55年 (子、大人)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 観測モデル：COHORT
  • 時間の展望：PROSPECTIVE

コホートと介入

グループ/コホート
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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Agreement Between AI-Derived and Arthrometer-Derived Side-to-Side Difference in Anterior Tibial Translation
時間枠：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.
Day 1 (index study examination)

二次結果の測定

結果測定
メジャーの説明
時間枠
Measurement Error of AI-Derived Anterior Tibial Translation Compared With Arthrometer Measurements
時間枠：Day 1 (index study examination)

The difference between AI-derived and arthrometer-derived measurements of anterior tibial translation will be quantified in millimeters using mean absolute error (MAE), root mean square error (RMSE), mean bias, and 95% limits of agreement.
Day 1 (index study examination)
Inter-Examiner Reliability of Arthrometer Measurements
時間枠：Day 1 (index study examination)

Reliability of anterior tibial translation and side-to-side difference measurements obtained independently by two orthopedic examiners using an arthrometer. Inter-examiner reliability will be assessed using intraclass correlation coefficients with 95% confidence intervals and Bland-Altman analysis.
Day 1 (index study examination)
Agreement Between AI Measurements Derived From Examinations Performed by Different Examiners
時間枠：Day 1 (index study examination)

Agreement between AI-derived anterior tibial translation and side-to-side difference obtained from videos of knee examinations performed independently by the two examiners. This outcome will assess the robustness of AI-derived measurements with respect to examiner-related variability.
Day 1 (index study examination)
Diagnostic Accuracy of AI-Derived Side-to-Side Difference for ACL Injury
時間枠：Day 1 (index study examination)

The ability of AI-derived side-to-side difference to discriminate participants with complete anterior cruciate ligament injury from ACL-intact controls will be assessed using receiver operating characteristic (ROC) curve analysis. Area under the curve (AUC), sensitivity, specificity, positive predictive value, and negative predictive value will be calculated.
Day 1 (index study examination)
diagnostic Accuracy of Arthrometer-Derived Side-to-Side Difference for ACL Injury
時間枠：Day 1 (index study examination)

The diagnostic performance of arthrometer-derived side-to-side difference for identifying complete anterior cruciate ligament injury will be evaluated using ROC curve analysis, including AUC, sensitivity, specificity, positive predictive value, and negative predictive value.
Day 1 (index study examination)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

ASL Lecce

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年9月15日

一次修了 (推定)

2026年12月31日

研究の完了 (推定)

2026年12月31日

試験登録日

最初に提出

2026年9月12日

QC基準を満たした最初の提出物

2026年9月17日

最初の投稿 (実際)

2026年9月22日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月22日

QC基準を満たした最後の更新が送信されました

2026年9月17日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

キーワード

その他の研究ID番号

  • ASLLECCE-AILAX-2026-01

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

De-identified data may be made available from the corresponding author upon reasonable request, subject to institutional and ethical approval.

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