Clinical Trial on the Efficacy and Safety of Biodegradable 3D-Printed Implants in Chest Wall Reconstruction Surgery

Clinical Trial on the Efficacy and Safety of Biodegradable 3D-Printed Implants in Chest Wall Reconstruction Surgery: A Prospective, Single-Arm Phase Il Study

This project focuses on patients with chest wall tumors who are expected to have a maximum intraoperative anterolateral chest wall defect diameter of 5-10 cm and require chest wall reconstruction with rib implants. It aims to evaluate the efficacy and safety of biodegradable 3D-printed implants in chest wall reconstruction surgery, providing a superior reconstruction strategy for patients with tumor-induced chest wall defects.

Study Overview

• Status: Not yet recruiting
• Conditions: Chest Wall Tumor
• Intervention / Treatment: Device: Chest wall reconstruction

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaolong Yan; Phone Number: +86 15991269383; Email: yanxiaolong@fmmu.edu.cn
• Study Contact Backup: Name: Lei Wang; Phone Number: +86 15093198361; Email: tuodi1986@126.com

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China
      • Tangdu Hospitial
      • Principal Investigator: Lei Wang
      • Principal Investigator: Xiaolong Yan
      • Contact: Xing Li; Phone Number: +86 02984777551; Email: tangduec@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients who meet all of the following criteria are eligible to participate in the study:

  1. Aged 18-70 years;
  2. No gender restriction;
  3. ECOG Performance Status 0-1;
  4. Chest CT-confirmed chest wall-originating tumor;
  5. Histologically/cytologically confirmed primary or metastatic chest wall tumor;
  6. Anticipated intraoperative anterolateral chest wall defect diameter 5-10 cm (maximum) or costal arch reconstruction required (investigator-assessed);
  7. Scheduled for prosthetic chest wall reconstruction;
  8. No prior chest wall reconstruction surgery;
  9. Willing to provide written informed consent and comply with follow-up visits and protocol requirements.

Exclusion Criteria:

• Patients who meet any of the following criteria are ineligible for this study:

  1. Patients with posterior chest wall defects;
  2. Uncontrolled underlying medical conditions or contraindications to general anesthesia;
  3. Pregnant or lactating women;
  4. Concurrent severe comorbidities that may interfere with study evaluations, including: Severe hepatic, cardiac, or renal diseases; Active malignancies (other than the indicated chest wall tumor); Alcohol use disorder
  5. lnability to provide reliable symptom reporting due to:P sychiatric disorders, Severe neurosis, Non-compliance with trial requirements
  6. Women of childbearing potential* and their partners unwilling to use effective contraception;
  7. Prior history of chest wall reconstruction surgery;
  8. Active uncontrolled bacterial, fungal, or viral infections;
  9. Participation in other clinical trials within 3 months prior to enrollment;
  10. Any other conditions deemedunsuitable by the investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chest wall reconstruction; Participants underwent extended resection of chest wall tumors followed by chest wall reconstruction using biodegradable polycaprolactone (PCL) 3D-printed rib implants.	Device: Chest wall reconstruction; Extended resection of chest wall tumors with subsequent biodegradable polycaprolactone (PCL) 3D-printed rib prosthetic reconstruction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abnormal breathing	Observe the integrity of the chest wall shape and the presence of abnormal breathing	Postoperative 1 month, 3 months, 6 months, and 12 months
Implant Degradation Performance Monitoring	Thin-section chest CT + 3D imaging (DICOM format data); Implant volume changes: Precise measurement of volumetric changes through 3D reconstruction;Implant density changes: Quantification of density changes using Hounsfield Units (HU values), including adjacent bone tissue changes; ③ Bone resorption/formation: Observation of potential bone loss or new bone formation; ④ Implant structural integrity: Assessment for cracks, voids, or other structural compromises.	Postoperative 1 month, 3 months, 6 months, and 12 months
Peri-implant Soft Tissue Evaluation	Chest MRI to evaluate thickening of the pleural fibrous layer surrounding the implant	Postoperative 1 month, 3 months, 6 months, and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in respiratory function--Pulmonary Function Test	The assessment of changes in respiratory function through pulmonary function tests includes indicators such as Forced Vital Capacity (FVC), Forced Expiratory Volume in the First Second (FEV₁), Total Lung Capacity (TLC), Residual Volume (RV), and Maximum Voluntary Ventilation (MVV).	Postoperative 1 month, 3 months, 6 months, and 12 months
Adverse events		form date of enrollment until the end of the study, assessed up to 12 months

Collaborators and Investigators

• Sponsor: Tang-Du Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: April 28, 2025
• First Submitted That Met QC Criteria: May 10, 2025
• First Posted (Actual): May 16, 2025

Study Record Updates

• Last Update Posted (Actual): May 16, 2025
• Last Update Submitted That Met QC Criteria: May 10, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: PCL Implant; Chest Wall Reconstruction; 3D Printing Technology
• Other Study ID Numbers: K202504-13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No