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

Summary

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, Insular/Las Palmas). Key Goals Assess short/mid-term outcomes (pain, breathing, complications). Compare results across patients/surgical techniques. Improve future prosthesis designs. Who Can Participate? Inclusion: Adults (18+) needing chest wall reconstruction. Signed consent for anonymized data sharing. Exclusion: Titanium allergies. Participation in conflicting studies. Patient Experience Pre-Surgery: CT scan creates a custom 3D prosthesis (made by Osteobionix® using Ti6AL4V-ELI titanium). Surgery: Surgeons implant the prosthesis, anchoring it to ribs/sternum. Follow-Up: Evaluations at discharge, 1/6/12 months (in-person or phone). Measures: Pain, lung function, imaging (X-ray/CT), complications (e.g., infection, implant failure). Privacy \& Ethics Data is anonymized and stored securely (REDCap system). Complies with European General Data Protection Regulation (EU GDPR) and Spanish data protection laws. Patients may withdraw anytime. For Healthcare Providers Collaboration: Open to thoracic surgeons/researchers. Data Access: Centralized via REDCap; analyzed by the coordinating team. Publications: Multicenter results will be published first; individual centers may later share their data. Why This Matters Addresses a gap in evidence for dynamic prostheses, which may offer: Better breathing mechanics vs. rigid materials. Fewer long-term complications (e.g., breakage). Could standardize best practices for complex reconstructions. Contact Lead Coordinator: Dr. Nicolás Moreno Mata (Hospital Ramón y Cajal, Madrid). Email: nicolas.moreno.hrc@gmail.com \| Phone: +34 647 609 363. Key Takeaways: Patients/Families: Learn if custom prostheses improve recovery. Providers: Contribute to advancing surgical options. Researchers: Access multicenter data on innovative implants.

Eligibility

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

Conditions4

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