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

Condition(s) studied

Investigational drug(s) / intervention(s)

Chest wall reconstruction with 3D printed titan custom prothesis: Dynamic Chest Wall Reconstruction with Patient-Specific 3D-Printed Titanium Prostheses" 1\. Intervention Overview A 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: Restore structural integrity of the thoracic cavity Preserve physiological chest wall dynamics during respiration Provide long-term biomechanical stability

Study 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

Primary outcome measure(s)

• Primary Respiratory Outcomes: Change from Baseline in Spirometric Parameters Following 3D-Printed Titanium Chest Wall Reconstruction — From enrollment to the end of treatment at 1 year
  \*Measured via spirometry according to ATS/ERS /The American Thoracic Society/European respiratory society) standards at 30 days and 1 year postoperatively\*
• Change from Preoperative Baseline in Forced Vital Capacity (FVC) — From enrollment to the end of treatment at 1 year
  \*Measured via spirometry according to ATS/ERS standards at 30 days and 1 year postoperatively\*
• Change from Preoperative Baseline in FEV₁/FVC Ratio — From enrollment to the end of treatment at 1 year
  Calculated from spirometry results at 30 days and 1 year postoperatively
• Change from Preoperative Baseline in Peak Expiratory Flow (PEF) — From enrollment to the end of treatment at 1 year
  Measured via spirometry at 30 days and 1 year postoperatively
• Change from Preoperative Baseline in Forced Expiratory Flow 25-75% (FEF₂₅-₇₅%) — From enrollment to the end of treatment at 1 year
  Measured via spirometry at 30 days and 1 year postoperatively

Trial sites (5)

More Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal trials in Spain