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

Tang-Du Hospital

Status: Not yet enrolling

Conditions: Chest Wall Tumor

Treatments: Device: Chest wall reconstruction

Study type: Interventional

Funder types: Other

Identifiers

NCT06977022

K202504-13

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who meet all of the following criteria are eligible to participate in the study:

  1. Aged 18-70 years;
  2. No gender restriction;
  3. ECOG Performance Status 0-1;
  4. Chest CT-confirmed chest wall-originating tumor;
  5. Histologically/cytologically confirmed primary or metastatic chest wall tumor;
  6. Anticipated intraoperative anterolateral chest wall defect diameter 5-10 cm (maximum) or costal arch reconstruction required (investigator-assessed);
  7. Scheduled for prosthetic chest wall reconstruction;
  8. No prior chest wall reconstruction surgery;
  9. 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:

  1. Patients with posterior chest wall defects;
  2. Uncontrolled underlying medical conditions or contraindications to general anesthesia;
  3. Pregnant or lactating women;
  4. 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
  5. lnability to provide reliable symptom reporting due to:P sychiatric disorders, Severe neurosis, Non-compliance with trial requirements
  6. Women of childbearing potential* and their partners unwilling to use effective contraception;
  7. Prior history of chest wall reconstruction surgery;
  8. Active uncontrolled bacterial, fungal, or viral infections;
  9. Participation in other clinical trials within 3 months prior to enrollment;
  10. Any other conditions deemedunsuitable by the investigator

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Chest wall reconstruction

Experimental group

Description:

Participants underwent extended resection of chest wall tumors followed by chest wall reconstruction using biodegradable polycaprolactone (PCL) 3D-printed rib implants.

Treatment:

Device: Chest wall reconstruction