Custom 3D-printed dynamic titanium implants to rebuild the chest wall
"Multicenter Registry for Chest Wall Reconstruction Surgery Using Custom Dynamic Prostheses PRODIPET"
This study tests custom 3D-printed dynamic titanium implants to rebuild the chest wall and help adults who need reconstruction after tumor removal or severe chest trauma breathe more comfortably and have less pain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal Academic / other |
| Drugs / interventions | radiation |
| Locations | 5 sites (Cruces, Basque Country and 4 other locations) |
| Trial ID | NCT07018960 on ClinicalTrials.gov |
What this trial studies
PRODIPET is a multicenter ambispective registry combining retrospective cases and new patients enrolled prospectively over a 24-month window, with each patient followed for 12 months. Participating centers use preoperative CT-based planning to design patient-specific Ti6Al4V implants manufactured by additive manufacturing and engineered to allow physiological rib movement. The registry collects standardized clinical outcomes including pain, respiratory function, complication rates, and imaging follow-up to characterize short- and mid-term safety and function. Final pooled analysis is planned after all patients complete 12 months of follow-up.
Who should consider this trial
Good fit: Adults (≥18 years) who require chest wall reconstruction for oncologic resection, severe trauma, or post-infection/post-radiation defects involving at least two ribs or the sternum with a defect ≥5 cm and who are planned for reconstruction with a custom 3D-printed titanium prosthesis are ideal candidates.
Not a fit: Patients with active systemic infection, severe uncorrectable cardiopulmonary disease (e.g., FEV1 <30% predicted), inadequate soft-tissue coverage, or complex vertebral involvement are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, these personalized dynamic implants could improve chest wall mechanics, reduce pain, and enhance breathing and quality of life compared with rigid reconstructions.
How similar studies have performed: Small case series and single-center reports have shown promising functional and safety results with custom 3D-printed titanium chest wall implants, but large multicenter comparative data remain limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Cruces, Basque Country and 4 other locations
- Hospital de Cruces — Cruces, Basque Country, Spain (Recruiting)
- Complejo Hospitalario Universitario Insular — Las Palmas de Gran Canaria, Canary Islands, Spain (Recruiting)
- Hospital Universitario Josep Trueta — Barcelona, Catalonia, Spain (Recruiting)
- Hospital Universitario Ramón y Cajal — Madrid, Madrid, Spain (Recruiting)
- Hospital Universitario de La Ribera — Alzira, Valencia, Spain (Recruiting)
Study contacts
- Study coordinator: Nicolás Moreno Mata MD, PhD, Medicine
- Email: nicolas.moreno.hrc@gmail.com
- Phone: 0034 647609363
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.