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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chest wall reconstruction | Device | Extended resection of chest wall tumors with subsequent biodegradable polycaprolactone (PCL) 3D-printed rib prosthetic reconstruction |
|
| 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)
| 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 |
| 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 |
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Inclusion Criteria:
Patients who meet all of the following criteria are eligible to participate in the study:
Exclusion Criteria:
Patients who meet any of the following criteria are ineligible for this study:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaolong Yan | Contact | +86 15991269383 | yanxiaolong@fmmu.edu.cn | |
| Lei Wang | Contact | +86 15093198361 | tuodi1986@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tangdu Hospitial | Xi'an | Shaanxi | China |
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| Adverse events | form date of enrollment until the end of the study, assessed up to 12 months |