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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Extended resection of chest wall tumors with subsequent biodegradable polycaprolactone (PCL) 3D-printed rib prosthetic reconstruction
Tangdu Hospitial
Xi'an, Shaanxi, China
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
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
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
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
Adverse events
Time frame: form date of enrollment until the end of the study, assessed up to 12 months
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