Innovative Approaches to Chest Wall Reconstruction: A Comparative Study of Rigid and Flexible Techniques

NCT07167810 | Completed DMC

• 1 other identifier: IRB/2025/1542/SIMS
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chest Wall Tumor

Keywords

resection of chest wall; chest wall reconstruction; bone cement; sternal steel wires

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  day 30 after surgery

Study Arms (2)

Bone Cement Group

EXPERIMENTAL

participants undergoing chest wall reconstruction using polymethyl methacrylate bone cement were included in this group

Procedure: bone cement

Steel Wire Group

EXPERIMENTAL

Participants undergoing chest wall reconstruction using no 5 sternal steel wires were included in this group.

Procedure: steel wires

Interventions

bone cement PROCEDURE

chest wall reconstruction using polymethyl methacrylate PMMA bone cement

Bone Cement Group

steel wires PROCEDURE

chest wall reconstruction using no 05 stainless sternal steel wires

Steel Wire Group

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing chest wall resection due to tumors, infections, or trauma.
• Adults aged more than 12 years.
• Patients who provide written informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Health Sciences Lahore: lead

Study Sites (1)

Services Institute of Medical Sciences (SIMS), Services Hospital Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Interventions

Bone Cements

Intervention Hierarchy (Ancestors)

Resins, Synthetic; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Specialty Uses of Chemicals; Chemical Actions and Uses; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Muhammad Shoaib Nabi

  Services Hospital, Lahore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: September 11, 2025
• Study Start: January 1, 2021
• Primary Completion: June 30, 2025
• Study Completion: August 31, 2025
• Last Updated: September 15, 2025

Record last verified: 2025-09

Locations

PA (1)