Custom 3D-printed dynamic titanium implants to rebuild the chest wall

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.