[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"malignant-bone-tumor-of-chest-wall\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:malignant-bone-tumor-of-chest-wall":46},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"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":19,"type":20},60,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27,28],"Chest Wall Tumors","Post-traumatic Syndrome","Malignant Bone Tumor of Chest Wall",[30,31,32],"Chest wall tumors","Chest wall reconstruction","Custom 3D-Printed Titanium Prostheses","RECRUITING","2025-08-07",{"date":36,"type":37},"2025-08-12","ACTUAL",{"date":39,"type":37},"2024-03-01",{"date":41,"type":20},"2025-12",{"name":43,"class":44},"Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal","OTHER",5,""]