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Chest Wall TumorsPRODIPETNCT07018960

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

A study testing Chest wall reconstruction with 3D printed titan custom prothesis in people with Chest Wall Tumors and Post-traumatic Syndrome, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 5 sites in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Chest wall reconstruction with 3D printed titan custom prothesis
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
5 sitesSpain
Study dates
1 Mar 2024to Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • 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:
Show all 16Show fewer
  • 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

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Nicolás Moreno Mata MD, PhD, Medicine contact

0034 647609363

nicolas.moreno.hrc@gmail.com

5 sites in 1 country

Spain5 sites, 5 recruiting
  • Hospital Universitario de La Ribera

    Alzira, Valencia

    Jose Galbis Carvajal., Medicine, 0034962542800, clinicagalbiscirugiatoracica@gmail.com

    Recruiting
  • Hospital Universitario Josep Trueta

    Barcelona, Catalonia

    Juan Carlos Trujillo-Reyes, Medicine, 0034 972940200, jtrujillo@santpau.cat

    Recruiting
  • Hospital de Cruces

    Cruces, Basque Country

    Unai Jiménez Maestre, Medicine, 0034 946006000, u.jimenezmaestre@gmail.com

    Recruiting
  • Complejo Hospitalario Universitario Insular

    Las Palmas de Gran Canaria, Canary Islands

    José Ramón Cano García, Medicine, 0034 928444000, joseravich@gmail.com

    Recruiting
  • Hospital Universitario Ramón y Cajal

    Madrid, Madrid

    Nicolás Moreno Mata

    Recruiting

Other trials in Spain

About this study

Official title: "Multicenter Registry for Chest Wall Reconstruction Surgery Using Custom Dynamic Prostheses PRODIPET"

PRODIPET Study Summary

Title: Multicenter Registry for Chest Wall Reconstruction Using Custom 3D-Printed Titanium Prostheses

Read more

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.

Read the 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)
  1. Surgical Phase:
  • Resection of affected chest wall segment
  • Implantation of custom prosthesis
  • Fixation to remaining ribs/sternum
  1. 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.

Being tested
Chest wall reconstruction with 3D printed titan custom prothesis
Keywords
Chest wall tumors, Chest wall reconstruction, Custom 3D-Printed Titanium Prostheses

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Chest wall reconstruction with 3D printed titan custom prothesisProcedure or surgery

    Dynamic Chest Wall Reconstruction with Patient-Specific 3D-Printed Titanium Prostheses"

    1. Intervention Overview

    A custom-designed, 3D-printed titanium prosthesis is surgically implanted to reconstruct chest wall defects following oncologic resection or traumatic injury. The prosthesis is engineered to:

    Restore structural integrity of the thoracic cavity Preserve physiological chest wall dynamics during respiration Provide long-term biomechanical stability

Study groups in NCT07018960
Study groupRoleWhat they receive
"Dynamic Chest Wall Reconstruction with Patient-Specific 3D-Printed Titanium Prostheses"ExperimentalNot described
Receives: Procedure: Chest wall reconstruction with 3D printed titan custom prothesis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Respiratory Outcomes: Change from Baseline in Spirometric Parameters Following 3D-Printed Titanium Chest Wall Reconstruction

    *Measured via spirometry according to ATS/ERS /The American Thoracic Society/European respiratory society) standards at 30 days and 1 year postoperatively*

    Measured: From enrollment to the end of treatment at 1 year

  2. Change from Preoperative Baseline in Forced Vital Capacity (FVC)

    *Measured via spirometry according to ATS/ERS standards at 30 days and 1 year postoperatively*

    Measured: From enrollment to the end of treatment at 1 year

  3. Change from Preoperative Baseline in FEV₁/FVC Ratio

    Calculated from spirometry results at 30 days and 1 year postoperatively

    Measured: From enrollment to the end of treatment at 1 year

  4. Change from Preoperative Baseline in Peak Expiratory Flow (PEF)

    Measured via spirometry at 30 days and 1 year postoperatively

    Measured: From enrollment to the end of treatment at 1 year

  5. Change from Preoperative Baseline in Forced Expiratory Flow 25-75% (FEF₂₅-₇₅%)

    Measured via spirometry at 30 days and 1 year postoperatively

    Measured: From enrollment to the end of treatment at 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2025
  2. Study start1 Mar 2024
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07018960
Sponsor's protocol ID
PRODIPET
Acronym
PRODIPET
Status last verified
Aug 2025
First submitted
26 May 2025
Last updated
12 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Chest wall reconstruction with 3D printed titan custom prothesis in people with Chest Wall Tumors and Post-traumatic Syndrome, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 5 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nicolás Moreno Mata MD, PhD, Medicine (0034 647609363, nicolas.moreno.hrc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Respiratory Outcomes: Change from Baseline in Spirometric Parameters Following 3D-Printed Titanium Chest Wall Reconstruction (time frame: From enrollment to the end of treatment at 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.

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