Comparative Study on Different Bone Reconstruction After Chest Wall Tumor Resection

May 20, 2025 updated by: Wu Weiming, Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Comparative Study on the Effect of New Reconstruction Methods and Traditional Reconstruction Methods on Bone Reconstruction After Chest Wall Tumor Resection

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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 the adoption of appropriate treatment plans based on the pathological results of the tumor, the location of tumor growth, the degree of local invasion of the tumor, and the presence of metastasis at the time of tumor detection. More importantly, surgical resection of primary malignant tumors of the chest wall should be carried out under careful planning, as most patients only have one chance of cure, and it becomes very difficult to undergo reoperation after tumor recurrence or surgical failure. Moreover, even if these patients undergo reoperation, their prognosis is also poor. To ensure the thoroughness of the surgery, it is usually necessary to perform an extensive resection of the chest wall tumor. However, the extensive chest wall defect formed after extensive resection can lead to the destruction of the integrity and stability of the chest wall, and if not handled properly, adverse consequences may occur. If chest wall softening, abnormal breathing, and acute respiratory failure occur early after surgery, it will affect the therapeutic effect of the surgery; In the late postoperative period, chest wall deformities, pulmonary hernias, chronic respiratory dysfunction, and even scoliosis may occur, affecting the quality of life. 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. In clinical treatment, it has been found that traditional reconstruction methods are unable to perform residual fixation for certain special areas of chest wall defects (such as posterior rib paravertebral tumors); There are also defects in the stability of the reconstructed implant, such as loosening, detachment, displacement, and even fracture. Therefore, it is necessary to design new chest wall reconstruction methods to meet clinical needs.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 18-70 years old, male or female not limited
  2. Anesthesia ASA score I-II
  3. Malignant tumor of soft tissue in the chest
  4. Malignant tumors of ribs, rib cartilage, and sternum
  5. Tumors with uncertain or unknown properties of ribs, rib cartilage, and sternum
  6. Giant benign tumors of ribs, rib cartilage, and sternum
  7. The preoperative examination results indicate that the tumor has not undergone distant metastasis
  8. Willing to participate in the research and sign the informed consent form

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: new methods on bone reconstruction after chest wall tumor resection
Using noose fixation for thoracic bone reconstruction
Procedure: methods on bone reconstrucion after chest wall tumor resection
Selecting appropriate implants for chest wall bone reconstruction
Active Comparator: traditional methods on bone reconstruction after chest wall tumor resection
Using bridging method for thoracic bone reconstruction
Procedure: methods on bone reconstrucion after chest wall tumor resection
Selecting appropriate implants for chest wall bone reconstruction

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Stability of implants
Time Frame: 3 years
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Respiratory discomfort
Time Frame: 3 years
Patient's respiratory discomfort in a calm state or walking state, measured as mild, moderate, or sereve after reconstruction surgery
3 years
Postoperative complications
Time Frame: 3 years
Pulmonary infection, atelectasis, pleural effusion, respiratory failure, postoperative drainage tube removal time, length of hospital stay
3 years
Complications of implants
Time Frame: 3 years
Fracture, displacement, infection, and compatibility of implants
3 years
Postoperative physical function status
Time Frame: 3 years
Karnofsky scoring scale
3 years
Quality of life
Time Frame: 3 years
EQ-5D-5L scoring scale, postoperative chronic pain level, postoperative recovery of daily work, postoperative changes in lung function (forced vital capacity FVC, first second forced vital capacity FEV1)
3 years
Postoperative chronic pain
Time Frame: 3 years
NRS（Numberical rating scale）, postoperative recovery of daily work, postoperative changes in lung function (forced vital capacity FVC, first second forced vital capacity FEV1)
3 years
Postoperative recovery of daily work
Time Frame: 3 years
The time from the day of surgery to the resumption of normal work, postoperative changes in lung function (forced vital capacity FVC, first second forced vital capacity FEV1)
3 years
Postoperative changes in lung function
Time Frame: 3 years
FVC（forced vital capacity FVC） and FEV1（first second forced vital capacity）at 1 month, 3 months, 6 months, 1 year, 1.5 years, 2 years, and 3 years after surgery
3 years
chest wall discomfort in patients after reconstruction surgery
Time Frame: 3 years
Patient chest wall discomfort in a calm or walking state, measured as mild, moderate, or severe after reconstrcution surgery
3 years
Chest wall appearance after reconstruction surgery
Time Frame: 3 years
The degree of recovery of chest wall appearance after surgery is evaluated based on three criteria: satisfactory, moderately satisfactory, and unsatisfactory.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 11, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 29, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20250418

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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