RecruitingNCT07636278

Augmented Reality in Surgery

Artificial Intelligence-Based Identification of the Target Zone on Arthroscopic Images During Knee Anterior Cruciate Ligament Reconstruction: An Observational Study


Sponsor

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Enrollment

100 participants

Start Date

May 26, 2026

Study Type

OBSERVATIONAL

Conditions

Summary

The goal of this observational study is to learn whether an artificial-intelligence software can reliably recognise the anatomical landmarks used to guide femoral bone tunnel placement on the arthroscopic monitor image during anterior cruciate ligament (ACL) reconstruction in adults. The main questions it aims to answer are: Can the software automatically tell when the arthroscopic image is clean enough to allow identification of these landmarks? Can the software accurately outline the key bony and cartilaginous landmarks on the femur that guide correct tunnel positioning? Participants will undergo their clinically indicated ACL reconstruction without modifications: short video sequences of the operative field will be recorded from the arthroscopic camera already used in routine practice, and used to train and validate the algorithms. No additional devices, manoeuvres or operative time are required.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • Age 18 years or older
  • Scheduled for primary arthroscopic anterior cruciate ligament reconstruction at IRCCS Galeazzi-Sant'Ambrogio
  • Signed written informed consent

Exclusion Criteria3

  • Revision anterior cruciate ligament reconstruction
  • Arthroscopic video quality judged inadequate by the investigator (artefacts, insufficient illumination, uninterpretable images)
  • Failure to sign informed consent, or withdrawal of consent

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Interventions

PROCEDUREPrimary arthroscopic anterior cruciate ligament reconstruction

Arthroscopic reconstruction of the anterior cruciate ligament performed per institutional surgical protocol. Cleaning of the lateral wall of the intercondylar notch in the resident's ridge region uses exclusively radiofrequency ablation; motorised instrumentation is avoided in this region to preserve the integrity of the bony landmark. Per enrolled patient, a continuous intra-operative recording is obtained from the unmodified standard arthroscopic camera column at 1920x1080 resolution and 60 fps; six 5-second segments are extracted, five documenting progressive cleaning steps of the lateral wall (0%, 25%, 50%, 75%, 100% completion) and one acquired with the surgical probe positioned on the posterior cartilaginous margin without occluding the candidate femoral footprint zone. The investigational software is not used to guide any intraoperative decision during enrolment; the algorithm operates offline on the recorded material.


Locations(1)

IRCCS Ospedale Galeazzi-Sant'Ambrogio

Milan, Michigan, Italy

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NCT07636278


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