Multicenter Registry for Chest Wall Reconstruction Surgery Using Custom Dynamic Prostheses PRODIPET

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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

Locations
Other Locations
Spain
Hospital Universitario de La Ribera
RECRUITING
Alzira
Hospital Universitario Josep Trueta
RECRUITING
Barcelona
Hospital de Cruces
RECRUITING
Cruces
Complejo Hospitalario Universitario Insular
RECRUITING
Las Palmas De Gran Canaria
Hospital Universitario Ramón y Cajal
RECRUITING
Madrid
Contact Information
Primary
Nicolás Moreno Mata MD, PhD, Medicine
nicolas.moreno.hrc@gmail.com
0034 647609363
Time Frame
Start Date: 2024-03-01
Estimated Completion Date: 2025-12
Participants
Target number of participants: 60
Treatments
Experimental: Dynamic Chest Wall Reconstruction with Patient-Specific 3D-Printed Titanium Prostheses
Related Therapeutic Areas
Sponsors
Collaborators: Hospital Universitario de la Ribera, Hospital Universitari de Girona Doctor Josep Trueta, Hospital Universitario Insular de Gran Canaria. Las Palmas de GG. Spain, Hospital de Cruces
Leads: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

This content was sourced from clinicaltrials.gov