Comparative Study on Different Bone Reconstruction After Chest Wall Tumor Resection

NCT06994533 | Not Yet Recruiting

• 1 other identifier: 20250418
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

Chest wall tumors are one of the important diseases in thoracic surgery, and surgery is still the main treatment for this disease in clinical practice. Surgery for chest wall tumors requires extensive resection. However, the extensive chest wall defect formed after extensive resection can lead to the destruction of the integrity and stability of the chest wall, thus requiring chest wall reconstruction. The reconstruction of the chest wall after resection has always been a difficult point in chest wall tumor surgery, and the reconstruction of the chest wall bone is a key point in chest wall reconstruction. The goals of successful chest wall bone reconstruction include restoring chest wall rigidity, minimizing chest wall deformities, maintaining lung mechanics, and protecting thoracic organs. At present, traditional reconstruction methods are based on simulating and restoring the anatomical structure of the thoracic spine. For certain special areas of chest wall defects (such as posterior rib and paraspinal tumors), it is difficult to perform residual fixation; At the same time, traditional reconstruction methods suffer from insufficient stability after reconstruction, such as loosening, detachment, displacement, and even fracture. Therefore, it is necessary to design new chest wall reconstruction methods to meet clinical needs.

Conditions

Chest Wall Tumor

Outcome Measures

Primary Outcomes (1)

• Stability of implants

  The occurrence of detachment, displacement, and fracture of implants during follow-up in patients undergoing chest wall tumor surgery after receiving a new reconstruction method

  3 years

Secondary Outcomes (10)

• Respiratory discomfort

  3 years

• Postoperative complications

  3 years

• Complications of implants

  3 years

• Postoperative physical function status

  3 years

• Quality of life

  3 years

Study Arms (2)

new methods on bone reconstruction after chest wall tumor resection

EXPERIMENTAL

Using noose fixation for thoracic bone reconstruction

Procedure: methods on bone reconstrucion after chest wall tumor resection

traditional methods on bone reconstruction after chest wall tumor resection

ACTIVE COMPARATOR

Using bridging method for thoracic bone reconstruction

Procedure: methods on bone reconstrucion after chest wall tumor resection

Interventions

methods on bone reconstrucion after chest wall tumor resection PROCEDURE

Selecting appropriate implants for chest wall bone reconstruction

new methods on bone reconstruction after chest wall tumor resection; traditional methods on bone reconstruction after chest wall tumor resection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old, male or female not limited
• Anesthesia ASA score I-II
• Malignant tumor of soft tissue in the chest
• Malignant tumors of ribs, rib cartilage, and sternum
• Tumors with uncertain or unknown properties of ribs, rib cartilage, and sternum
• Giant benign tumors of ribs, rib cartilage, and sternum
• The preoperative examination results indicate that the tumor has not undergone distant metastasis
• Willing to participate in the research and sign the informed consent form

You may not qualify if:

• Patients with distant metastasis detected during preoperative examination
• Inoperable tumor
• During the examination, it was discovered that the patient had another type of malignant tumor present
• ECOG 4
• Suffering from active or chronic fungal/bacterial/viral infections
• History of allergy to anesthesia related drugs
• Heart and lung dysfunction, liver and kidney dysfunction, inability to tolerate surgery
• Patients with mental disorders who are unable to cooperate with treatment

Sponsors & Collaborators

• Shanghai Jiao Tong University Affiliated Sixth People's Hospital: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Thoracic Surgery

Study Record Dates

• First Submitted: May 11, 2025
• First Posted: May 29, 2025
• Study Start: July 1, 2025
• Primary Completion: July 31, 2025
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share