Clinical trial NCT07018960: "Multicenter Registry for Chest Wall Reconstruction Using Custom Dynamic Prostheses (PRODIPET)"
Official title: "Multicenter Registry for Chest Wall Reconstruction Surgery Using Custom Dynamic Prostheses PRODIPET"
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chest Wall Tumors
Sternum Tumors
Rib Tumors Requiring Extensive Resection (3 Ribs or 5 cm Defects)
Complex Post-traumatic Defects With Chest Wall Instability
Keywords: Chest wall tumors
Chest wall reconstruction
Custom 3D-Printed Titanium Prostheses
Lead sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Sponsor class: OTHER
Collaborators: name: Hospital Universitario de la Ribera
name: Hospital de Cruces
name: Hospital Universitario Insular de Gran Canaria. Las Palmas de GG. Spain
name: Hospital Universitari de Girona Doctor Josep Trueta
First posted: 2025-06-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: Here's a detailed yet accessible description of the PRODIPET study:

\*\*PRODIPET Study: A Comprehensive Multicenter Investigation into 3D-Printed Titanium Chest Wall Reconstruction\*\*

\*\*Background and Rationale\*\* Chest wall defects resulting from tumor resections or traumatic injuries present significant surgical challenges. Traditional reconstruction methods using rigid materials like methylmethacrylate or steel plates often compromise respiratory mechanics and patient comfort. The PRODIPET study examines an innovative solution: patient-specific, 3D-printed titanium prostheses designed to replicate natural chest wall dynamics.

\*\*Study Design and Methodology\*\*

This national multicenter registry combines:

* Retrospective data: Cases from participating centers where titanium prostheses were previously implanted
* Prospective data: New cases enrolled over a 24-month period (January 2024-January 2026)

\*\*Technical Innovation\*\*

The prostheses are:

* Custom-designed using preoperative CT scans
* Manufactured via electron beam melting of Ti6AL4V-ELI titanium powder
* Engineered to provide:

  * Anatomical precision
  * Dynamic flexibility mimicking natural rib movement
  * Reduced imaging artifacts for better postoperative monitoring

\*\*Clinical Protocol\*\*

1. Preoperative Phase:

   * Multidisciplinary evaluation (surgeons, radiologists, engineers)
   * Virtual surgical planning using 3D reconstruction
   * Prosthesis fabrication by Osteobionix® (2-3 week turnaround)
2. Surgical Phase:

   * Resection of affected chest wall segment
   * Implantation of custom prosthesis
   * Fixation to remaining ribs/sternum
3. Postoperative Follow-up:

   * Standardized evaluations at:

     * Hospital discharge
     * 1 month
     * 6 months
     * 12 months
   * Assessments include:

     * Pulmonary function tests
     * Pain scales (VAS)
     * CT imaging
     * Quality of life questionnaires

\*\*Data Collection and Management\*\*

* Secure REDCap database hosted by EJIE (Informatic Society of Basque Government, IT)
* Comprehensive variables tracked:

  * Demographic data
  * Surgical details (operative time, blood loss)
  * Prosthesis characteristics (size, fixation method)
  * Complication rates
  * Functional outcomes

\*\*Participant Protection\*\*

* CEIm (ethical committee)-approved protocol (Hospital Ramón y Cajal Ethics Committee)
* GDPR-compliant data handling
* Two-tier identification system:

  1. Local centers maintain identifiable information
  2. Central registry uses anonymized codes
* Right to withdraw without penalty

\*\*Scientific Objectives\*\*

Primary:

* Determine prosthesis durability (12-month failure rate)
* Assess restoration of pulmonary function

Secondary:

* Identify optimal candidates for this technique
* Establish complication profiles
* Compare outcomes across surgical centers
* Refine prosthesis design parameters

\*\*Clinical Significance\*\*

This study addresses critical gaps in thoracic reconstruction by:

* Providing real-world evidence for a novel technology
* Establishing standardized protocols
* Creating a benchmark for future innovations
* Potentially improving quality of life for patients requiring extensive chest wall resection

\*\*Collaborative Structure\*\*

* Coordinating Committee: 4 lead thoracic surgeons
* Participating Centers: Open to all Spanish hospitals meeting criteria
* Industry Partner: Osteobionix® (device fabrication only, no data access)

\*\*Dissemination Plan\*\*

* Interim analysis at 12 months
* Final results publication anticipated 2027
* Data sharing policy:

  * Coordinating committee controls primary dataset
  * Participating centers may publish local data after multicenter publication

This rigorous, patient-focused investigation represents a significant advancement in thoracic surgical care, combining cutting-edge engineering with clinical expertise to improve outcomes for patients with complex chest wall defects.

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

Primary outcomes:
measure: Primary Respiratory Outcomes: Change from Baseline in Spirometric Parameters Following 3D-Printed Titanium Chest Wall Reconstruction
timeFrame: From enrollment to the end of treatment at 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Las Palmas de Gran Canaria
country: Spain
facility: Complejo Hospitalario Universitario Insular
state: Canarias
city: Barcelona
country: Spain
facility: Hospital Universitario Josep Trueta
state: Cataluña
city: Alzira
country: Spain
facility: Hospital Universitario de La Ribera
state: Comunidad Valenciana
city: Cruces
country: Spain
facility: Hospital de Cruces
state: Pais vasco
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
Study officials:
References: