Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06448728
Status:
COMPLETED
Last Update Posted:
2024-06-12
First Post:
2024-06-03
Brief Title:
Surgical Outcome Studies in Thoracic Wall Reconstruction With Codubix Ribs
Sponsor:
University Hospital Basel Switzerland
Organization:
University Hospital Basel Switzerland
Study Overview
Official Title:
Surgical Outcome Studies in Thoracic Wall Reconstruction With Codubix Ribs
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 surgeons 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 walls 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
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 surgeons 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 walls 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None