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Augmented Reality in Surgery

NCT07636278 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2026-06-09

No results posted yet for this study

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.

Conditions

  • Anterior Cruciate Ligament (ACL) Tear

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.

Sponsors & Collaborators

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

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-26
Primary Completion
2026-12-31
Completion
2027-05-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07636278 on ClinicalTrials.gov