Chest Wall TumorNCT07167810
Innovative Approaches to Chest Wall Reconstruction: A Comparative Study of Rigid and Flexible Techniques
A study testing bone cement and steel wires in people with Chest Wall Tumor, run by University of Health Sciences Lahore at 1 site in Pakistan.
Trial summary
Chest wall resections, often performed for tumors, infections, or trauma, result in significant defects that require reconstruction to restore structural integrity and functionality. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Chest Wall Tumor
- What is being tested?
- bone cement and steel wires
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2021to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing chest wall resection due to tumors, infections, or trauma.
- Adults aged more than 12 years.
- Patients who provide written informed consent.
Who cannot join
- Patients with contraindications to surgery.
- Patients with pre-existing chest wall deformities or severe chronic respiratory diseases.
- Patients who undergo reoperation or develop intraoperative complications affecting the chest wall reconstruction.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Services Institute of Medical Sciences (SIMS), Services Hospital Lahore
Lahore, Punjab Province, 54000
About this study
Chest wall resections, often performed for tumors, infections, or trauma, result in significant defects that require reconstruction to restore structural integrity and functionality. The chest wall, a complex dynamic structure composed of both rigid and soft tissues, plays a vital role in protecting thoracic organs and maintaining the mechanics of respiration. Reconstruction following chest wall resection is critical not only to achieve defect closure but also to preserve respiratory mechanics and minimize postoperative complications. The primary goals include providing structural support, ensuring stability, and achieving soft tissue coverage while maintaining chest wall flexibility and minimizing pain. the main objectives of this study is to compare the postoperative pain control and recovery outcomes between chest wall reconstruction using PMMA bone cement and twisted stainless steel wires in patients undergoing chest wall reconstruction and to evaluate the impact of chest wall reconstruction with steel wires versus PMMA on chest wall recoil.
Read the detailed description
Various materials and techniques have been employed for chest wall reconstruction, focusing on both soft and rigid defect coverage. Traditional approaches often involve synthetic materials, including mesh, titanium plates, and polymethyl methacrylate (PMMA) bone cement. PMMA, widely known as bone cement, has been a cornerstone material due to its significant compressive strength and ease of application. However, it possesses notable drawbacks, including low tensile strength, lack of adhesive properties, and complications arising from direct exposure to the medullary cavity, such as thermal necrosis, infection, and chronic pain. Studies have also highlighted the static nature of PMMA, which can compromise chest wall dynamics and contribute to suboptimal respiratory outcomes. Furthermore, PMMA is relatively expensive, making it less accessible in resource-constrained settings like Pakistan, where socioeconomic challenges often dictate treatment choices.
In contrast, the use of twisted stainless steel wires (No. 05) for chest wall reconstruction offers a cost-effective and practical alternative. Steel wires provide robust structural support, allow dynamic movement of the chest wall during respiration, and are associated with improved postoperative pain control. Unlike PMMA, which forms a rigid and static patch, steel wires enable better chest wall recoil, which is crucial for maintaining normal respiratory mechanics. Additionally, studies suggest that the use of steel wires reduces the incidence of chronic pain, as they do not involve direct exposure to synthetic materials that could irritate surrounding tissues or provoke inflammatory responses. The affordability and simplicity of steel wire-based reconstruction make it particularly suitable for underserved populations in Pakistan, where healthcare resources are limited, and the majority of patients cannot afford expensive surgical materials.
Chest wall reconstruction techniques that aim to replicate the rib cage's normal anatomy and function have shown promise in improving patient outcomes. Recent innovations, such as neoribs constructed with PMMA, attempt to restore the rib structure and mechanics. However, while effective in achieving structural stability, these techniques often fail to replicate the chest wall's dynamic behavior due to the rigid nature of the material. In contrast, the flexibility and adaptability of steel wires make them an attractive alternative, especially in low-resource settings. Comparative studies have shown that patients reconstructed with steel wires experience less postoperative pain, faster recovery, and better respiratory mechanics than those reconstructed with PMMA.
This study, to be conducted at the Thoracic Surgery Unit of Services Hospital, Lahore, aims to compare the outcomes of chest wall reconstruction using PMMA bone cement versus No. 05 twisted steel wires. The focus will be on evaluating postoperative pain control and chest wall recoil during respiration. Services Hospital, as a tertiary care center and referral unit, manages a significant caseload of thoracic surgeries and serves a predominantly low-income population, making it an ideal setting for this research. By addressing the unique challenges faced by this population and leveraging the available resources, this study seeks to provide evidence-based recommendations for optimizing chest wall reconstruction techniques. The findings are expected to have significant implications for improving patient outcomes and reducing healthcare costs in similar resource-limited settings.
- Conditions
- Chest Wall Tumor
- Being tested
- bone cement, steel wires
- Keywords
- resection of chest wall, chest wall reconstruction, bone cement, sternal steel wires
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bone cementProcedure or surgery
chest wall reconstruction using polymethyl methacrylate PMMA bone cement
steel wiresProcedure or surgery
chest wall reconstruction using no 05 stainless sternal steel wires
| Study group | Role | What they receive |
|---|---|---|
| Bone Cement Group | Experimental | participants undergoing chest wall reconstruction using polymethyl methacrylate bone cement were included in this group Receives: Procedure: bone cement |
| Steel Wire Group | Experimental | Participants undergoing chest wall reconstruction using no 5 sternal steel wires were included in this group. Receives: Procedure: steel wires |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-operative pain
Pain will be assessed using a Visual Analogue Scale (VAS, 0-10 cm), where 0 = no pain and 10 = worst imaginable pain. Assessments will be performed at rest and during deep inspiration/cough. Scores will be collected by trained nursing staff once daily. The primary analysis will report mean VAS score at each time point (with SD).
Measured: post-operative day 01, day 3 and day 07
Chest Wall integrity
Radiological evaluation, X-ray will be conducted 1 month post-surgery to assess rib alignment and chest wall integrity.
Measured: day 30 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start1 Jan 2021
- Primary completion30 Jun 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest Wall TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study was a parallel retrospective comparative cohort study conducted at the Thoracic Surgery Unit of Services Hospital, Lahore. The retrospective component included patients who have previously undergone chest wall reconstruction using either PMMA bone cement or No. 05 twisted stainless steel wires.
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Health Sciences Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeeshan Sarwar, University of Health Sciences Lahore
- Investigators
- Muhammad Shoaib Nabi, Principal investigator, Services Hospital, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07167810
- Sponsor's protocol ID
- IRB/2025/1542/SIMS
- Status last verified
- Sep 2025
- First submitted
- 3 Sep 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Approaches to Chest Wall Reconstruction: A Comparative Study of Rigid and Flexible Techniques
- ClinicalTrials.gov ID
- NCT07167810
- Acronym / sponsor ID
- IRB/2025/1542/SIMS
- Conditions
- Chest Wall Tumor
- Keywords
- resection of chest wall, chest wall reconstruction, bone cement, sternal steel wires
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of Health Sciences LahoreUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chest wall resections, often performed for tumors, infections, or trauma, result in significant defects that require reconstruction to restore structural integrity and functionality. The chest wall, a complex dynamic structure composed of both rigid and soft tissues, plays a vital role in protecting thoracic organs and maintaining the mechanics of respiration. Reconstruction following chest wall resection is critical not only to achieve defect closure but also to preserve respiratory mechanics and minimize postoperative complications. The primary goals include providing structural support, ensuring stability, and achieving soft tissue coverage while maintaining chest wall flexibility and minimizing pain. the main objectives of this study is to compare the postoperative pain control and recovery outcomes between chest wall reconstruction using PMMA bone cement and twisted stainless steel wires in patients undergoing chest wall reconstruction and to evaluate the impact of chest wall reconstruction with steel wires versus PMMA on chest wall recoil.
Detailed description
Various materials and techniques have been employed for chest wall reconstruction, focusing on both soft and rigid defect coverage. Traditional approaches often involve synthetic materials, including mesh, titanium plates, and polymethyl methacrylate (PMMA) bone cement. PMMA, widely known as bone cement, has been a cornerstone material due to its significant compressive strength and ease of application. However, it possesses notable drawbacks, including low tensile strength, lack of adhesive properties, and complications arising from direct exposure to the medullary cavity, such as thermal necrosis, infection, and chronic pain. Studies have also highlighted the static nature of PMMA, which can compromise chest wall dynamics and contribute to suboptimal respiratory outcomes. Furthermore, PMMA is relatively expensive, making it less accessible in resource-constrained settings like Pakistan, where socioeconomic challenges often dictate treatment choices.
In contrast, the use of twisted stainless steel wires (No. 05) for chest wall reconstruction offers a cost-effective and practical alternative. Steel wires provide robust structural support, allow dynamic movement of the chest wall during respiration, and are associated with improved postoperative pain control. Unlike PMMA, which forms a rigid and static patch, steel wires enable better chest wall recoil, which is crucial for maintaining normal respiratory mechanics. Additionally, studies suggest that the use of steel wires reduces the incidence of chronic pain, as they do not involve direct exposure to synthetic materials that could irritate surrounding tissues or provoke inflammatory responses. The affordability and simplicity of steel wire-based reconstruction make it particularly suitable for underserved populations in Pakistan, where healthcare resources are limited, and the majority of patients cannot afford expensive surgical materials.
Chest wall reconstruction techniques that aim to replicate the rib cage's normal anatomy and function have shown promise in improving patient outcomes. Recent innovations, such as neoribs constructed with PMMA, attempt to restore the rib structure and mechanics. However, while effective in achieving structural stability, these techniques often fail to replicate the chest wall's dynamic behavior due to the rigid nature of the material. In contrast, the flexibility and adaptability of steel wires make them an attractive alternative, especially in low-resource settings. Comparative studies have shown that patients reconstructed with steel wires experience less postoperative pain, faster recovery, and better respiratory mechanics than those reconstructed with PMMA.
This study, to be conducted at the Thoracic Surgery Unit of Services Hospital, Lahore, aims to compare the outcomes of chest wall reconstruction using PMMA bone cement versus No. 05 twisted steel wires. The focus will be on evaluating postoperative pain control and chest wall recoil during respiration. Services Hospital, as a tertiary care center and referral unit, manages a significant caseload of thoracic surgeries and serves a predominantly low-income population, making it an ideal setting for this research. By addressing the unique challenges faced by this population and leveraging the available resources, this study seeks to provide evidence-based recommendations for optimizing chest wall reconstruction techniques. The findings are expected to have significant implications for improving patient outcomes and reducing healthcare costs in similar resource-limited settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study was a parallel retrospective comparative cohort study conducted at the Thoracic Surgery Unit of Services Hospital, Lahore. The retrospective component included patients who have previously undergone chest wall reconstruction using either PMMA bone cement or No. 05 twisted stainless steel wires.
| Arm | Type | Receives |
|---|---|---|
| Bone Cement Group | Experimental | Procedure: bone cementparticipants undergoing chest wall reconstruction using polymethyl methacrylate bone cement were included in this group |
| Steel Wire Group | Experimental | Procedure: steel wiresParticipants undergoing chest wall reconstruction using no 5 sternal steel wires were included in this group. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing chest wall resection due to tumors, infections, or trauma.
- Adults aged more than 12 years.
- Patients who provide written informed consent.
Key exclusion criteria (3 listed)
- Patients with contraindications to surgery.
- Patients with pre-existing chest wall deformities or severe chronic respiratory diseases.
- Patients who undergo reoperation or develop intraoperative complications affecting the chest wall reconstruction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bone cementchest wall reconstruction using polymethyl methacrylate PMMA bone cement | Procedure or surgery | Bone Cement Group |
| steel wireschest wall reconstruction using no 05 stainless sternal steel wires | Procedure or surgery | Steel Wire Group |
Primary outcome
post-operative pain
Time frame: post-operative day 01, day 3 and day 07
Pain will be assessed using a Visual Analogue Scale (VAS, 0-10 cm), where 0 = no pain and 10 = worst imaginable pain. Assessments will be performed at rest and during deep inspiration/cough. Scores will be collected by trained nursing staff once daily. The primary analysis will report mean VAS score at each time point (with SD).
Chest Wall integrity
Time frame: day 30 after surgery
Radiological evaluation, X-ray will be conducted 1 month post-surgery to assess rib alignment and chest wall integrity.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Shoaib Nabi principal investigator
Services Hospital, Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bone cement and steel wires in people with Chest Wall Tumor, run by University of Health Sciences Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post-operative pain (time frame: post-operative day 01, day 3 and day 07). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.