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

ConditionChest Wall Tumor
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorTang-Du Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18-70 years;

No gender restriction;

ECOG Performance Status 0-1;

Chest CT-confirmed chest wall-originating tumor;

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Chest wall reconstruction

    Device

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

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Chest wall reconstructionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Abnormal breathing

Observe the integrity of the chest wall shape and the presence of abnormal breathing

Time frame
Postoperative 1 month, 3 months, 6 months, and 12 months
2

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.

Time frame
Postoperative 1 month, 3 months, 6 months, and 12 months
3

Peri-implant Soft Tissue Evaluation

Chest MRI to evaluate thickening of the pleural fibrous layer surrounding the implant

Time frame
Postoperative 1 month, 3 months, 6 months, and 12 months

Secondary outcomes

1

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).

Time frame
Postoperative 1 month, 3 months, 6 months, and 12 months
2

Adverse events

Time frame
form date of enrollment until the end of the study, assessed up to 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tang-Du Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: