Clinical trial NCT06977022: Clinical Trial on the Efficacy and Safety of Biodegradable 3D-Printed Implants in Chest Wall Reconstruction Surgery
Official title: Clinical Trial on the Efficacy and Safety of Biodegradable 3D-Printed Implants in Chest Wall Reconstruction Surgery: A Prospective, Single-Arm Phase Il Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chest Wall Tumor
Keywords: PCL Implant
Chest Wall Reconstruction
3D Printing Technology
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
First posted: 2025-05-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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

Primary outcomes:
measure: Abnormal breathing
timeFrame: Postoperative 1 month, 3 months, 6 months, and 12 months
measure: Implant Degradation Performance Monitoring
timeFrame: Postoperative 1 month, 3 months, 6 months, and 12 months
measure: Peri-implant Soft Tissue Evaluation
timeFrame: Postoperative 1 month, 3 months, 6 months, and 12 months
Secondary outcomes:
measure: Changes in respiratory function--Pulmonary Function Test
timeFrame: Postoperative 1 month, 3 months, 6 months, and 12 months
measure: Adverse events
timeFrame: form date of enrollment until the end of the study, assessed up to 12 months
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Tangdu Hospitial
state: Shaanxi
Study officials:
References: