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"Multicenter Registry for Chest Wall Reconstruction Using Custom Dynamic Prostheses (PRODIPET)"

RecruitingNAAges 18 Years - anyAllFundacion para la Investigacion Biomedica del Hos…
NCT07018960 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

PRODIPET Study Summary Title: Multicenter Registry for Chest Wall Reconstruction Using Custom 3D-Printed Titanium Prostheses Purpose The PRODIPET study evaluates the safety and effectiveness of personalized, dynamic titanium prostheses for reconstructing the chest wall after: Tumor 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. Study Design Type: Multicenter, ambispective (retrospective + prospective data). Duration: Prospective: 24 months (Jan 2024-Jan 2026). Follow-up: 12 months per patient (final analysis by 2027). Centers: Major Spanish hospitals (Ramón y Cajal/Madrid, La Ribera/Alzira, Cruces/Baracaldo, I

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📋 Eligibility rules (as published)
Inclusion Criteria Patients must meet ALL of the following: • Age: ≥18 years Clinical Indication: * Requires chest wall reconstruction due to: * Oncologic resection (primary tumors, metastases) * Traumatic injury (flail chest, severe rib fractures) * Post-infection/post-radiation defects * Defect Characteristics: * Involves ≥2 ribs or sternum with instability * Minimum defect size: 5 cm in largest dimension * Surgical Plan: * Scheduled for reconstruction with 3D-printed custom titanium prosthesis * Consent: Willing to provide informed consent for: * Surgery * Data collection * Follow-up evaluations * Exclusion Criteria Patients will be excluded if ANY of the following apply: * Medical Contraindications: * Active systemic infection (e.g., sepsis) * Severe cardiopulmonary disease (FEV₁ \<30% predicted) * Uncorrectable coagulopathy (INR \>1.5) * Technical Limitations: * Inadequate soft tissue coverage for prosthesis * Vertebral column involvement requiring complex fixation * Material Incompatibility: * Known hypersensitivity to titanium alloys * Study Logistics: * Participation in another conflicting clinical trial * Inability to complete follow-up (e.g., no fixed address) * Ethical Considerations: * Pregnancy (due to elective CT scan requirements) * Prisoners or cognitively impaired patients without legal guardians
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What it tests

  • Chest wall reconstruction with 3D printed titan custom prothesis
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Where

5 sites
Hospital de Cruces
Cruces, Spain
Complejo Hospitalario Universitario Insular
Las Palmas de Gran Canaria, Spain
Hospital Universitario Josep Trueta
Barcelona, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain
Hospital Universitario de La Ribera
Alzira, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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