[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594401":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":26,"responsibleParty":93,"collaborators":95,"id":105,"slug":106,"hasResults":107,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":107,"sex":113,"minAge":114,"maxAge":11,"enrollmentInfo":115,"targetDuration":11,"studyType":118,"phases":119,"briefSummary":121,"conditions":122,"keywords":126,"overallStatus":29,"whyStopped":11,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},{"fullName":5,"class":6},"Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"\"Dynamic Chest Wall Reconstruction with Patient-Specific 3D-Printed Titanium Prostheses\"","EXPERIMENTAL",null,[13],"Procedure: Chest wall reconstruction with 3D printed titan custom prothesis",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"PROCEDURE","Chest wall reconstruction with 3D printed titan custom prothesis","Dynamic Chest Wall Reconstruction with Patient-Specific 3D-Printed Titanium Prostheses\"\n\n1\\. Intervention Overview\n\nA custom-designed, 3D-printed titanium prosthesis is surgically implanted to reconstruct chest wall defects following oncologic resection or traumatic injury. The prosthesis is engineered to:\n\nRestore structural integrity of the thoracic cavity Preserve physiological chest wall dynamics during respiration Provide long-term biomechanical stability",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"Nicolás Moreno Mata MD, PhD, Medicine","CONTACT","0034 647609363","nicolas.moreno.hrc@gmail.com",[27,39,54,68,79],{"facility":28,"status":29,"city":30,"state":31,"zip":11,"country":32,"countryCode":33,"cosmosGeoPoint":11,"geoPoint":11,"contacts":34},"Hospital de Cruces","RECRUITING","Cruces","Basque Country","Spain","ES",[35],{"name":36,"role":23,"phone":37,"phoneExt":11,"email":38},"Unai Jiménez Maestre, Medicine","0034 946006000","u.jimenezmaestre@gmail.com",{"facility":40,"status":29,"city":41,"state":42,"zip":11,"country":32,"countryCode":33,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Complejo Hospitalario Universitario Insular","Las Palmas de Gran Canaria","Canary Islands",{"type":44,"coordinates":45},"Point",[46,47],-15.41573,28.10178,{"lat":47,"lon":46},[50],{"name":51,"role":23,"phone":52,"phoneExt":11,"email":53},"José Ramón Cano García, Medicine","0034 928444000","joseravich@gmail.com",{"facility":55,"status":29,"city":56,"state":57,"zip":11,"country":32,"countryCode":33,"cosmosGeoPoint":58,"geoPoint":62,"contacts":63},"Hospital Universitario Josep Trueta","Barcelona","Catalonia",{"type":44,"coordinates":59},[60,61],2.15899,41.38879,{"lat":61,"lon":60},[64],{"name":65,"role":23,"phone":66,"phoneExt":11,"email":67},"Juan Carlos Trujillo-Reyes, Medicine","0034 972940200","jtrujillo@santpau.cat",{"facility":69,"status":29,"city":70,"state":70,"zip":11,"country":32,"countryCode":33,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Hospital Universitario Ramón y Cajal","Madrid",{"type":44,"coordinates":72},[73,74],-3.70256,40.4165,{"lat":74,"lon":73},[77],{"name":78,"role":23,"phone":11,"phoneExt":11,"email":11},"Nicolás Moreno Mata",{"facility":80,"status":29,"city":81,"state":82,"zip":11,"country":32,"countryCode":33,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"Hospital Universitario de La Ribera","Alzira","Valencia",{"type":44,"coordinates":84},[85,86],-0.43333,39.15,{"lat":86,"lon":85},[89],{"name":90,"role":23,"phone":91,"phoneExt":11,"email":92},"Jose Galbis Carvajal., Medicine","0034962542800","clinicagalbiscirugiatoracica@gmail.com",{"type":94,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[96,99,100,102],{"name":97,"class":98},"Hospital Universitario de la Ribera","UNKNOWN",{"name":28,"class":6},{"name":101,"class":98},"Hospital Universitario Insular de Gran Canaria. Las Palmas de GG. Spain",{"name":103,"class":104},"University Hospital of Girona Dr. Josep Trueta","NETWORK","100594401","multicenter-registry-for-chest-wall-reconstruction-using-custom-dynamic-prostheses-prodipet-100594401",false,"NCT07018960","\"Multicenter Registry for Chest Wall Reconstruction Using Custom Dynamic Prostheses (PRODIPET)\"","\"Multicenter Registry for Chest Wall Reconstruction Surgery Using Custom Dynamic Prostheses PRODIPET\"","PRODIPET","Inclusion Criteria\n\nPatients must meet ALL of the following:\n\n• Age: ≥18 years\n\nClinical Indication:\n\n* Requires chest wall reconstruction due to:\n* Oncologic resection (primary tumors, metastases)\n* Traumatic injury (flail chest, severe rib fractures)\n* Post-infection\u002Fpost-radiation defects\n* Defect Characteristics:\n* Involves ≥2 ribs or sternum with instability\n* Minimum defect size: 5 cm in largest dimension\n* Surgical Plan:\n* Scheduled for reconstruction with 3D-printed custom titanium prosthesis\n* Consent: Willing to provide informed consent for:\n* Surgery\n* Data collection\n* Follow-up evaluations\n* Exclusion Criteria\n\nPatients will be excluded if ANY of the following apply:\n\n* Medical Contraindications:\n* Active systemic infection (e.g., sepsis)\n* Severe cardiopulmonary disease (FEV₁ \\\u003C30% predicted)\n* Uncorrectable coagulopathy (INR \\>1.5)\n* Technical Limitations:\n* Inadequate soft tissue coverage for prosthesis\n* Vertebral column involvement requiring complex fixation\n* Material Incompatibility:\n* Known hypersensitivity to titanium alloys\n* Study Logistics:\n* Participation in another conflicting clinical trial\n* Inability to complete follow-up (e.g., no fixed address)\n* Ethical Considerations:\n* Pregnancy (due to elective CT scan requirements)\n* Prisoners or cognitively impaired patients without legal guardians","ALL","18 Years",{"count":116,"type":117},60,"ESTIMATED","INTERVENTIONAL",[120],"NA","PRODIPET Study Summary\n\nTitle: Multicenter Registry for Chest Wall Reconstruction Using Custom 3D-Printed Titanium Prostheses\n\nPurpose\n\nThe PRODIPET study evaluates the safety and effectiveness of personalized, dynamic titanium prostheses for reconstructing the chest wall after:\n\nTumor resection (e.g., sarcomas, lung cancer). Severe trauma (e.g., multiple rib fractures). Traditional methods (metal plates, mesh) often lack flexibility, potentially causing pain or breathing difficulties. This study tests 3D-printed titanium implants designed to mimic natural rib movement, improving function and comfort.\n\nStudy Design\n\nType: Multicenter, ambispective (retrospective + prospective data).\n\nDuration:\n\nProspective: 24 months (Jan 2024-Jan 2026). Follow-up: 12 months per patient (final analysis by 2027). Centers: Major Spanish hospitals (Ramón y Cajal\u002FMadrid, La Ribera\u002FAlzira, Cruces\u002FBaracaldo, Insular\u002FLas Palmas).\n\nKey Goals\n\nAssess short\u002Fmid-term outcomes (pain, breathing, complications). Compare results across patients\u002Fsurgical techniques. Improve future prosthesis designs. Who Can Participate?\n\nInclusion:\n\nAdults (18+) needing chest wall reconstruction. Signed consent for anonymized data sharing.\n\nExclusion:\n\nTitanium allergies. Participation in conflicting studies. Patient Experience\n\nPre-Surgery:\n\nCT scan creates a custom 3D prosthesis (made by Osteobionix® using Ti6AL4V-ELI titanium).\n\nSurgery:\n\nSurgeons implant the prosthesis, anchoring it to ribs\u002Fsternum.\n\nFollow-Up:\n\nEvaluations at discharge, 1\u002F6\u002F12 months (in-person or phone). Measures: Pain, lung function, imaging (X-ray\u002FCT), complications (e.g., infection, implant failure).\n\nPrivacy \\& Ethics\n\nData is anonymized and stored securely (REDCap system). Complies with European General Data Protection Regulation (EU GDPR) and Spanish data protection laws.\n\nPatients may withdraw anytime. For Healthcare Providers\n\nCollaboration: Open to thoracic surgeons\u002Fresearchers. Data Access: Centralized via REDCap; analyzed by the coordinating team. Publications: Multicenter results will be published first; individual centers may later share their data.\n\nWhy This Matters\n\nAddresses a gap in evidence for dynamic prostheses, which may offer:\n\nBetter breathing mechanics vs. rigid materials. Fewer long-term complications (e.g., breakage). Could standardize best practices for complex reconstructions. Contact\n\nLead Coordinator: Dr. Nicolás Moreno Mata (Hospital Ramón y Cajal, Madrid). Email: nicolas.moreno.hrc@gmail.com \\| Phone: +34 647 609 363.\n\nKey Takeaways:\n\nPatients\u002FFamilies: Learn if custom prostheses improve recovery. Providers: Contribute to advancing surgical options. Researchers: Access multicenter data on innovative implants.",[123,124,125],"Chest Wall Tumors","Post-traumatic Syndrome","Malignant Bone Tumor of Chest Wall",[127,128,129],"Chest wall tumors","Chest wall reconstruction","Custom 3D-Printed Titanium Prostheses","2025-08-07",{"date":132,"type":133},"2025-08-12","ACTUAL",{"date":135,"type":133},"2024-03-01",{"date":137,"type":117},"2025-12",{"name":5,"class":6},5]