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

NCT07018960 | Recruiting DMC

• 1 other identifier: PRODIPET
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 5

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.

Conditions

Chest Wall Tumors; Post-traumatic Syndrome; Malignant Bone Tumor of Chest Wall

Keywords

Chest wall tumors; Chest wall reconstruction; Custom 3D-Printed Titanium Prostheses

Outcome Measures

Primary Outcomes (5)

• 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\*

  From enrollment to the end of treatment at 1 year

• Change from Preoperative Baseline in Forced Vital Capacity (FVC)

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

  From enrollment to the end of treatment at 1 year

• Change from Preoperative Baseline in FEV₁/FVC Ratio

  Calculated from spirometry results at 30 days and 1 year postoperatively

  From enrollment to the end of treatment at 1 year

• Change from Preoperative Baseline in Peak Expiratory Flow (PEF)

  Measured via spirometry at 30 days and 1 year postoperatively

  From enrollment to the end of treatment at 1 year

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

  Measured via spirometry at 30 days and 1 year postoperatively

  From enrollment to the end of treatment at 1 year

Study Arms (1)

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

EXPERIMENTAL

Procedure: Chest wall reconstruction with 3D printed titan custom prothesis

Interventions

Chest wall reconstruction with 3D printed titan custom prothesis PROCEDURE

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal: lead
• Hospital Universitario de la Ribera: collaborator
• Hospital de Cruces: collaborator
• Hospital Universitario Insular de Gran Canaria. Las Palmas de GG. Spain: collaborator
• University Hospital of Girona Dr. Josep Trueta: collaborator

Study Sites (5)

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

Related Links

• Related Info

Central Study Contacts

Nicolás Moreno Mata MD, PhD, Medicine

CONTACT

0034 647609363; nicolas.moreno.hrc@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: June 13, 2025
• Study Start: March 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 12, 2025

Record last verified: 2025-08

Locations

ES (5)