NCT07338006

Brief Summary

Chest wall reconstruction following tumor or infection-related resections remains a challenging aspect of thoracic surgery, requiring restoration of structural stability and preservation of respiratory mechanics. While polymethyl methacrylate (PMMA) bone cement has long been used for rigid reconstruction, its limitations-including high cost, rigidity, infection risk, and interference with normal respiratory motion-pose challenges in resource-constrained settings. Twisted stainless steel wires offer a low-cost, flexible alternative that allows dynamic chest wall movement and easier adaptability in low- and middle-income countries such as Pakistan. To compare postoperative outcomes, complications, and cost-effectiveness of chest wall reconstruction using twisted stainless steel wires versus PMMA bone cement over a two-year period (January 2025 - December 2026). This prospective cohort study was conducted in the Department of Thoracic Surgery, Services Hospital, Lahore, a high-volume tertiary care and referral center. Patients undergoing chest wall reconstruction following resection for tumors, infections, or trauma were enrolled and divided into two groups based on the reconstruction technique used: Group A (twisted steel wires) and Group B (PMMA bone cement). Parameters assessed included postoperative pain (VAS scores), respiratory function, chest wall stability, complications (infection, wound dehiscence, prosthesis exposure), duration of hospital stay, readmission rate, and cost of reconstruction. Data were analyzed to compare clinical and functional outcomes between both cohorts.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
10mo left

Started Jan 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Jan 2021Mar 2027

Study Start

First participant enrolled

January 1, 2021

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

January 3, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 13, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

January 13, 2026

Status Verified

January 1, 2026

Enrollment Period

6 years

First QC Date

January 3, 2026

Last Update Submit

January 3, 2026

Conditions

Keywords

Chest wall reconstructionBone cementStainless steel wireThoracic surgeryPostoperative painFunctional outcomes

Outcome Measures

Primary Outcomes (1)

  • Postoperative Pain Assessment:

    Postoperative analgesia followed a standardized multimodal protocol of intravenous paracetamol and NSAIDs unless contraindicated, supplemented with intravenous morphine (0.05-0.1 mg/kg) as required. Thoracic epidural or paravertebral blockade was used selectively based on resection extent or anesthetist preference. Rescue analgesia was administered when VAS pain scores were ≥4 at rest or ≥5 during movement.

    24 hours, 48 hours and 7 days post-operatively

Secondary Outcomes (1)

  • Chest Wall Movement

    1 month and 3 months post-operatively

Study Arms (2)

Bone cement Arm

ACTIVE COMPARATOR

This arm included patients that underwent chest wall reconstruction using bone cement

Procedure: chest wall reconstruction

Steel wire arm

EXPERIMENTAL

This arm included patients that underwent chest wall reconstruction with steel wires

Procedure: Chest wall reconstruction

Interventions

Chest wall reconstruction was performed using PMMA bone cement molded intraoperatively over a polypropylene mesh to form a rigid prosthesis. The construct was fixed to the adjacent ribs with nonabsorbable sutures or wires.

Bone cement Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged ≥18 years undergoing partial or full-thickness chest wall resection.
  • Defects requiring rigid or semi-rigid reconstruction involving two or more ribs or the sternum.

You may not qualify if:

  • Patients with small defects managed by primary closure or soft tissue-only reconstruction.
  • Patients with concurrent major intrathoracic resections (e.g., pneumonectomy) may confound postoperative respiratory assessment.
  • Recurrent disease requiring revision reconstruction.
  • Patients unwilling or unable to provide consent or comply with follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Services Hospital, Lahore

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

MeSH Terms

Conditions

NeoplasmsPain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

Muhammad Shoaib Nabi, FCPS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

January 3, 2026

First Posted

January 13, 2026

Study Start

January 1, 2021

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

March 31, 2027

Last Updated

January 13, 2026

Record last verified: 2026-01

Locations