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RECRUITING
NCT07636278

Augmented Reality in Surgery

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

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2026-05-26

Completion Date

2027-05-31

Last Updated

2026-06-09

Healthy Volunteers

No

Interventions

PROCEDURE

Primary 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