ThoracicNCT06448728
Surgical Outcome Studies in Thoracic Wall Reconstruction With Codubix® Ribs
An observational study of Thoracic, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic
- How many people
- 9 participants
- Where
- 1 siteSwitzerland
- Study dates
- 23 Aug 2023to 18 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel, Clinic for Thoracic Surgery
Basel, Canton of Basel-City, 4031
About this study
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.
Read the 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
- Keywords
- Thoracic Wall Reconstruction, Surgical Implantation, Reconstruction Materials, Codubix® Ribs Prosthesis
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of mobility
To evaluate mobility of the prosthesis, routine screening for thoracic wall mobility is performed using MRI.
Measured: At least 3 months post surgery
Physical examination
To evaluate the thoracic wall stability and aesthetic outcome, a physical examination is done.
Measured: 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.
Measured: 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).
Measured: At least 3 months post surgery
Secondary outcomes (3)
Details on thoracic wall resection
Information on the thoracic wall resection, including indication, surgical approach and, extend of resection performed are collected.
Measured: At least 3 months post surgery
Risk of mortality
The risk of mortality is evaluated using the Charlson Comorbidity index (CCI). The CCI assigns a score to pre-existing medical conditions, with higher scores on a scale from 0 to 33 indicating a greater burden of comorbidities and a higher risk of mortality.
Measured: At least 3 months post surgery
Number of in-hospital complications
The number of in-hospital complications is assessed using the Clavien-Dindo Classification and CTCAE v5.0 (Common Terminology Criteria for Adverse Events, version 5.0). Both systems grade and classify the severity of adverse events or complications experienced by patients undergoing treatments or surgeries, ranging from ranging from grade I/1 (mild) to grade V/5 (death).
Measured: At least 3 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start23 Aug 2023
- Primary completion18 Dec 2023
- Study completion18 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThoracicStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meret Appel, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06448728
- Sponsor's protocol ID
- 2023-01132; kt24Appel
- Other IDs
- 2023
- Status last verified
- Jun 2024
- First submitted
- 3 Jun 2024
- Last updated
- 12 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Outcome Studies in Thoracic Wall Reconstruction With Codubix® Ribs
- ClinicalTrials.gov ID
- NCT06448728
- Acronym / sponsor ID
- 2023-01132; kt24Appel
- Conditions
- Thoracic
- Keywords
- Thoracic Wall Reconstruction, Surgical Implantation, Reconstruction Materials, Codubix® Ribs Prosthesis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 23 Aug 2023 (actual)
- Primary completion
- 18 Dec 2023 (actual)
- Study completion
- 18 Dec 2023 (actual)
- First posted
- 7 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of mobility
Time frame: At least 3 months post surgery
To evaluate mobility of the prosthesis, routine screening for thoracic wall mobility is performed using MRI.
Physical examination
Time frame: At least 3 months post surgery
To evaluate the thoracic wall stability and aesthetic outcome, a physical examination is done.
Assessment of disability and symptoms
Time frame: At least 3 months post surgery
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.
Assessment of pain
Time frame: At least 3 months post surgery
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).
3 secondary outcomes
Details on thoracic wall resection
Time frame: At least 3 months post surgery
Risk of mortality
Time frame: At least 3 months post surgery
Number of in-hospital complications
Time frame: At least 3 months post surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meret Appel principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracic, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of mobility (time frame: At least 3 months post surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2024.