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

Launched by FUNDACION PARA LA INVESTIGACION BIOMEDICA DEL HOSPITAL UNIVERSITARIO RAMON Y CAJAL · Jun 5, 2025

Keywords

ClinConnect Summary

The PRODIPET study is a clinical trial designed to test a new way of rebuilding the chest wall for patients who have had tumors or severe injuries. It focuses on using custom-made, 3D-printed titanium implants that can move like natural ribs, unlike traditional materials that can be stiff and uncomfortable. The goal is to see if these new implants improve patients' breathing, reduce pain, and lead to fewer complications after surgery. The trial will take place at several major hospitals in Spain, and researchers will follow participants for up to a year after their surgery.

To be eligible for this study, participants must be adults aged 18 or older who need chest wall reconstruction due to the removal of tumors or significant injury. They should also be willing to share their health information for research purposes. Participants will undergo a CT scan to create a personalized implant before surgery, and they will have check-ups at different times after the operation to monitor their recovery. Importantly, patient privacy is a priority, and all personal data will be kept secure and confidential.

Gender

ALL

Eligibility criteria

• • 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