Surgical Outcome Studies in Thoracic Wall Reconstruction With Codubix® Ribs

NCT ID: NCT06448728

Last Updated: 2024-06-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 9 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-08-23
• Study Completion Date: 2023-12-18

Brief Summary

The aim of this observational study is to analyze the short- and long-term outcome after surgical implantation of the Codubix® Ribs prosthesis in a descriptive and non-statistical way.

Detailed Description

An intact thoracic wall is essential for maintaining organ and respiratory function and upper extremity mobility, and therefore may require surgical intervention if portions of the thoracic wall have been destroyed or removed. Thoracic wall reconstruction is typically needed for cancers originating in or invading the chest wall or for large defects resulting from surgery that removes multiple ribs or the sternum. Less commonly, it is required due to malformations, infections, radiation injuries, or trauma to maintain respiratory function, protect internal organs, and avoid cosmetic defects.

There are several synthetic, metallic, and biologic materials on the market for thoracic wall reconstruction, each with its advantages and disadvantages, and none has proven superior to the others, often being chosen based on the surgeon's experience and preference. Codubix® Ribs, a knitted prosthesis made of polypropylene and polyester yarn, has been used since 2018 for thoracic wall reconstruction due to its high strength, low weight, and non-reactive properties. Moreover, it is radiolucent, easily adjustable to the chest wall's curvature, and maintain enough stiffness to not require additional materials, even for large defects. Although well-established in neurosurgery, its use in thoracic surgery is relatively new and not yet extensively reviewed in literature.

The primary objective is to evaluate the postoperative outcomes after thoracic wall reconstruction with Codubix® Ribs examining mobility, stability, aesthetic outcome and pain. The secondary objectives are to evaluate specific indications for chest wall resection found in the participants and in-hospital complications during the hospital stay.

The results of this study, summarizing our experiences with the relatively unknown prosthesis Codubix Ribs, aim to provide valuable insights and contribute to the broader knowledge base of the medical community regarding effective thoracic wall reconstruction materials.

Conditions

Thoracic

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Patients that received full thickness resection of the thoracic wall and reconstruction using Codubix® Ribs
• Patients of all co-morbidities and gender
• Patients that signed written informed consent according to ICH-GCP regulations prior to initiation of any protocol-specific follow-up events
• Patients of age >18 years at the time of informed consent

Exclusion Criteria

• Patients who have not signed hospital's general consent form for the use of their health-related data for scientific purposes will not be included into the project.
• Patients that received thoracic wall reconstruction with other materials than Codubix® Ribs
• Inability to follow procedures or insufficient knowledge of language
• Inability to give consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Meret Appel

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

University Hospital Basel, Clinic for Thoracic Surgery

Basel, Canton of Basel-City, Switzerland

Countries

Switzerland

Other Identifiers

2023-01132; kt24Appel

Identifier Type: -

Identifier Source: org_study_id