[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643107":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":26,"responsibleParty":43,"collaborators":10,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":47,"sex":53,"minAge":54,"maxAge":10,"enrollmentInfo":55,"targetDuration":10,"studyType":58,"phases":10,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":29,"whyStopped":10,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Adult patients undergoing primary arthroscopic ACL reconstruction",null,"Adult patients (age 18 years or older) consecutively enrolled at IRCCS Galeazzi-Sant'Ambrogio (Milan, Italy) for primary arthroscopic anterior cruciate ligament reconstruction. The procedure follows the institutional standard of care; no investigational device, additional intraoperative manoeuvre or operative-time extension is introduced for study purposes. During surgery, a continuous arthroscopic video is recorded from the standard arthroscopic camera column already in clinical use, and short segments are extracted to document the lateral wall of the intercondylar notch at progressive cleaning steps and the instrument-anatomy relationship at the fully-cleaned step. The recorded material is pseudonymised and used to train and validate computer vision algorithms for landmark identification on the arthroscopic image. The first 50 enrolled subjects contribute to algorithm training; the subsequent 50 to independent validation.",[13],"Procedure: Primary arthroscopic anterior cruciate ligament reconstruction",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"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.",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Andrea Cusumano, MD","CONTACT","0039 3483733690","dr.andreacusumano@gmail.com",[27],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"IRCCS Ospedale Galeazzi-Sant'Ambrogio","RECRUITING","Milan","Michigan","20157","Italy","IT",{"type":36,"coordinates":37},"Point",[38,39],12.59836,42.78235,{"lat":39,"lon":38},[42],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},{"type":44,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100643107","augmented-reality-in-surgery-100643107",false,"NCT07636278","Augmented Reality in Surgery","Artificial Intelligence-Based Identification of the Target Zone on Arthroscopic Images During Knee Anterior Cruciate Ligament Reconstruction: An Observational Study","ARS","Inclusion Criteria:\n\n* Age 18 years or older\n* Scheduled for primary arthroscopic anterior cruciate ligament reconstruction at IRCCS Galeazzi-Sant'Ambrogio\n* Signed written informed consent\n\nExclusion Criteria:\n\n* Revision anterior cruciate ligament reconstruction\n* Arthroscopic video quality judged inadequate by the investigator (artefacts, insufficient illumination, uninterpretable images)\n* Failure to sign informed consent, or withdrawal of consent","ALL","18 Years",{"count":56,"type":57},100,"ESTIMATED","OBSERVATIONAL","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:\n\nCan 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?\n\nParticipants 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.",[61],"Anterior Cruciate Ligament (ACL) Tear",[63,64,65,66,67,68,69,70,71,72,73],"Anterior Cruciate Ligament Reconstruction","Arthroscopy","Artificial Intelligence","Deep Learning","Computer Vision","Semantic Segmentation","Augmented Reality","Surgery, Computer-Assisted","Image Processing","Femoral Tunnel","Decision Support Systems","2026-06-03",{"date":76,"type":77},"2026-06-09","ACTUAL",{"date":79,"type":77},"2026-05-26",{"date":81,"type":57},"2027-05-31",{"name":5,"class":6},1]