[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100562489":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":34,"locations":40,"responsibleParty":65,"collaborators":68,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":11,"eligibilityCriteria":88,"healthyVolunteers":84,"sex":89,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":11,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":11,"overallStatus":43,"whyStopped":11,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"Corporacion Parc Tauli","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"3D digital surgery group","EXPERIMENTAL",null,[13],"Procedure: patients treated using 3D technology and Patient-Specific Instrumentation",{"label":15,"type":16,"description":11,"interventionNames":17},"2D conventional surgery group","ACTIVE_COMPARATOR",[18],"Procedure: Patients treated with conventional surgery, without using 3D technology",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"PROCEDURE","patients treated using 3D technology and Patient-Specific Instrumentation","3D Digital surgery includes:\n\n* 3D Surgical Planning using biomedical engineering software; 3D visualization of the patients anatomy and surgical simulation.\n* Use of personalized surgical guides created through additive manufacturing.\n* Use of personalized implants created through additive manufacturing.\n\n  3 surgical procedures are studied in this study; radius osteotomy, acetabular arthroplasty and spinal arthrodesis",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"Patients treated with conventional surgery, without using 3D technology","Conventional surgery includes:\n\n* 2D planning using TC and x-rays\n* Free-hand surgery\n* Use of generic, non-personalized implants\n\n  3 surgical procedures are studied in this study; radius osteotomy, acetabular arthroplasty and spinal arthrodesis",[15],[30],{"name":31,"affiliation":32,"role":33},"Ferran Fillat-Gomà","Corporacion PT","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":11,"email":39},"Xavier Garcia-Ruz","CONTACT","644685674","xgarcia@tauli.cat",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Hospital Parc Taulí","RECRUITING","Sabadell","Barcelona","08208","Spain","ES",{"type":50,"coordinates":51},"Point",[52,53],2.10942,41.54329,{"lat":53,"lon":52},[56,60,63],{"name":57,"role":37,"phone":58,"phoneExt":11,"email":59},"Mireia Montserrat Viñas","610523153","mmvinas@tauli.cat",{"name":61,"role":37,"phone":38,"phoneExt":11,"email":62},"Xavier Garcia","xgarciar@tauli.cat",{"name":64,"role":33,"phone":11,"phoneExt":11,"email":11},"Ferran Fillat",{"type":33,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Ferran Fillat Gomà","Principal Investigator",[69,71,73,76,78,80],{"name":70,"class":6},"Hospital Clinic of Barcelona",{"name":72,"class":6},"Hospital de Granollers",{"name":74,"class":75},"Fundació Hospital d'Olot i Comarcal de la Garrotxa","UNKNOWN",{"name":77,"class":6},"Hospital de la Santa creu i Sant Pau - Barcelona",{"name":79,"class":6},"Consorci Hospitalari de Vic",{"name":81,"class":6},"Corporació de Salut del Maresme i la Selva","100562489","clinical-evaluation-and-cost-effectiveness-analysis-of-3d-digital-surgery-in-traumatology-100562489",false,"NCT06603831","Clinical Evaluation and Cost-effectiveness Analysis of 3D Digital Surgery in Traumatology","Randomized, Prospective and Multicenter Clinical Study for the Clinical Evaluation and Cost-effectiveness Analysis of 3D Digital Surgery in Traumatology and Orthopedic Surgery","Inclusion Criteria:\n\n\\- Patients that requires one of the following surgical procedures \u002F interventions: Radius osteotomy due to non-articular metaphyseal malunion Complex acetabular arthroplasty Thoracic-lumbar spine arthrodesis.\n\n-Patients that can understand the clinical study and that are able to read, understand and sign the consent form\n\nExclusion Criteria:\n\n* Patients that are not able to read, understand or sign the consent form.\n* Patients that can't or have no support to complete the clinical trial.\n* Patients with complex deformities or complications that would require mandatory personalized digital surgery treatment","ALL","18 Years","80 Years",{"count":93,"type":94},180,"ESTIMATED","INTERVENTIONAL",[97],"NA","Digital surgery, in combination with patient specific instrumentation (PSI) is being used more and more in traumatology due to its proven benefits and applications. Nowadays, medical case planning and an optimal preparation before surgery are still a challenge for surgeons. This lack of preparation is translated into longer surgical procedures, potential complications, unnecessary sterilization of materials and a high number of fluoroscopies. 2D techniques such as Magnetic Resonance Imaging (MRI), Computed Tomography (CT) and X-rays remain essential for medical planning, however, in many cases, a 3D visualization is needed to achieve better results, especially in complex cases.The use of personalized medical instruments such as surgical guides has proven to increase clinical accuracy, assuring a better correction of bone deformities, and allowing a more precise location of implants and screw positioning. Furthermore, the use of 3D-printed patient-specific prosthesis can lead to better clinical outcomes as they reduce the number of complications as well as they present a longer lifespan compared to conventional generic implants.Despite the potential of 3D technology in the medical field, there is still a lack of robust studies that compares clinical benefits between digital surgery and conventional 2D surgery, and its economic impact is still unknown. Thus, the investigators propose this randomized, prospective and multi-center clinical study to evaluate the use of 3D technology in traumatology. The aim of this project is to prove that digital surgery is a cost-effective methodology and therefore it should be adopted by the public health system as a gold standard procedure.",[100,101,102,103,104,105,106,107,108,109,110,111],"Radius; Deformity","Hip Osteoarthritis","Hip Arthritis","Hip Arthropathy","Spine Injury","Radius; Anomaly","Vertebra; Degeneration","Vertebral Fracture","Hip Prosthesis Infection","Spinal Fusion","Spine Osteoarthritis","Spinal Deformity","2024-11-08",{"date":114,"type":115},"2024-11-12","ACTUAL",{"date":117,"type":115},"2024-10-21",{"date":119,"type":94},"2027-12-31",{"name":5,"class":6},1]