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

Recruiting now · Not applicable

Conditions studied: Chest Wall Tumors, Post-traumatic Syndrome, Malignant Bone Tumor of Chest Wall

In brief

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.

Key facts

Study ID: NCT07018960
Run by: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
People needed: 60
Starts: 2024-03-01
Expected to finish: 2025-12-01
Last updated by the study team: 2025-08-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

Where it is running

Hospital de Cruces — Cruces, Basque Country, Spain (enrolling)
Complejo Hospitalario Universitario Insular — Las Palmas de Gran Canaria, Canary Islands, Spain (enrolling)
Hospital Universitario Josep Trueta — Barcelona, Catalonia, Spain (enrolling)
Hospital Universitario Ramón y Cajal — Madrid, Madrid, Spain (enrolling)
Hospital Universitario de La Ribera — Alzira, Valencia, Spain (enrolling)

Full record on ClinicalTrials.gov

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