Surgical Outcome Studies in Thoracic Wall Reconstruction With Codubix® Ribs

NCT06448728 | Completed

• 1 other identifier: 2023-01132; kt24Appel
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Thoracic

Keywords

Thoracic Wall Reconstruction; Surgical Implantation; Reconstruction Materials; Codubix® Ribs Prosthesis

Outcome Measures

Primary Outcomes (4)

• Assessment of mobility

  To evaluate mobility of the prosthesis, routine screening for thoracic wall mobility is performed using MRI.

  At least 3 months post surgery

• Physical examination

  To evaluate the thoracic wall stability and aesthetic outcome, a physical examination is done.

  At least 3 months post surgery

• Assessment of disability and symptoms

  To assess arm, shoulder and hand disability and symptoms, the QuickDASH (Disabilities of the Arm, Shoulder, and Hand) questionnaire is used. It consists of 11 items that inquire about the individual's ability to perform various activities, such as self-care, work, and recreational activities, as well as the severity of symptoms experienced. It provides a quick and comprehensive assessment of upper extremity function and symptoms, with higher scores on a scale from 0 to 100 indicating greater disability, where 0 represents no disability and 100 represents the most severe disability.

  At least 3 months post surgery

• Assessment of pain

  To assess the postoperative pain, the Numeric Rating Scale (NRS) is used. The NRS is a commonly used tool for assessing pain intensity,asking the patient to rate their pain on a scale from 0 (no pain) to 10 (worst pain).

  At least 3 months post surgery

Secondary Outcomes (3)

• Details on thoracic wall resection

  At least 3 months post surgery

• Risk of mortality

  At least 3 months post surgery

• Number of in-hospital complications

  At least 3 months post surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study collects and evaluates retrospective data of approximately 14 patients who underwent full-thickness thoracic wall resection and reconstruction with Codubix® Ribs starting on February 25th, 2018 up to December 31st, 2023 at the thoracic surgery department of the University Hospital of Basel.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel, Clinic for Thoracic Surgery

Basel, Canton of Basel-City, 4031, Switzerland

Location

Study Officials

• Meret Appel

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 7, 2024
• Study Start: August 23, 2023
• Primary Completion: December 18, 2023
• Study Completion: December 18, 2023
• Last Updated: June 12, 2024

Record last verified: 2024-06

Locations

CH (1)