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

Inclusion criteria

• 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.

Exclusion criteria

• 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