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

NCT06977022 | Not Yet Recruiting

• 1 other identifier: K202504-13
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chest Wall Tumor

Keywords

PCL Implant; Chest Wall Reconstruction; 3D Printing Technology

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Changes in respiratory function--Pulmonary Function Test

  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

Study Arms (1)

Chest wall reconstruction

EXPERIMENTAL

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

Interventions

Chest wall reconstruction DEVICE

Extended resection of chest wall tumors with subsequent biodegradable polycaprolactone (PCL) 3D-printed rib prosthetic reconstruction

Chest wall reconstruction

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who meet all of the following criteria are eligible to participate in the study:
• Aged 18-70 years;
• No gender restriction;
• ECOG Performance Status 0-1;
• Chest CT-confirmed chest wall-originating tumor;
• Histologically/cytologically confirmed primary or metastatic chest wall tumor;
• Anticipated intraoperative anterolateral chest wall defect diameter 5-10 cm (maximum) or costal arch reconstruction required (investigator-assessed);
• Scheduled for prosthetic chest wall reconstruction;
• No prior chest wall reconstruction surgery;
• Willing to provide written informed consent and comply with follow-up visits and protocol requirements.

You may not qualify if:

• Patients who meet any of the following criteria are ineligible for this study:
• Patients with posterior chest wall defects;
• Uncontrolled underlying medical conditions or contraindications to general anesthesia;
• Pregnant or lactating women;
• 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
• lnability to provide reliable symptom reporting due to:P sychiatric disorders, Severe neurosis, Non-compliance with trial requirements
• Women of childbearing potential\* and their partners unwilling to use effective contraception;
• Prior history of chest wall reconstruction surgery;
• Active uncontrolled bacterial, fungal, or viral infections;
• Participation in other clinical trials within 3 months prior to enrollment;
• Any other conditions deemedunsuitable by the investigator

Sponsors & Collaborators

• Tang-Du Hospital: lead

Study Sites (1)

Tangdu Hospitial

Xi'an, Shaanxi, China

Location

Central Study Contacts

Xiaolong Yan

CONTACT

+86 15991269383; yanxiaolong@fmmu.edu.cn

Lei Wang

CONTACT

+86 15093198361; tuodi1986@126.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: April 28, 2025
• First Posted: May 16, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)