Rib FracturesREMOVENCT06003595
Long-term Outcome After Removal of Rib Stabilization Hardware in Patients With Blunt Chest Trauma
An observational study of Rib Fractures, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The main study objective is to evaluate the long-term outcome in a prospective follow-up visit of patients who underwent hardware removal after surgical stabilization of rib fractures (SSRF) after a blunt chest trauma . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rib Fractures
- What is being tested?
- Data collection on patient reported long-term outcome of SSRF hardware removal
- How many people
- 28 participants
- Where
- 1 siteSwitzerland
- Study dates
- 4 Aug 2023to 8 Jan 2024
- 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: Patients with blunt chest trauma who underwent hardware removal after rib stabilisation between September 01, 2017 and September 30, 2023. The patients received hardware implantation and hardware removal at the Department of Thoracic Surgery of the University Hospital Basel.
Who may be able to join
- Patient treated at the Department of Thoracic Surgery, USB for implantation and removal of rib fixation hardware
- Blunt chest trauma/injuries to the thorax: Patient with blunt chest trauma (with or without polytrauma) before SSRF implantation and subsequent hardware removal
- Rib fracture: At least one rib fracture (unilateral and/or bilateral incl. flail chest) on radiography chest imaging on time of SSRF implantation. Patients with rib fracture/non-union due to pseudoarthrosis are included.
- Rib fixation material implantation and removal: Patient underwent surgery for rib fracture and implantation of at least one (partially or complete) rib fixation material (at any time point) with later hardware removal (partially or complete) (at any time point between 01.09.2017 and 30.09.2023)
- Patient of all gender
- Patient ≥18 years at time point of rib stabilization
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- Signed written informed consent prior to initiation of any protocol-specific activities/procedure
- Patient will be included if a signed USB general research consent approval is available but patient cannot be reached or disagreed to come to the follow-up visit
- Patient who died will be included if a signed USB general research consent approval is available
Who cannot join
- Patients who received re-osteosynthesis on the same day as hardware removal
- Patients received conservative therapy or surgery with absorbable plates
- On hardware implantation:
- Penetrating chest trauma
- Only random findings of rib fractures
- Solitary sternocostal joint fracture and/or solitary sternum fracture and/or solitary fractures of rib connecting parts and/or solitary thoracic spine/vertebra fracture
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- In-hospital: Patient suffered only iatrogenic rib facture during a surgery, cardiac surgery
- Rib fractures/non-unions caused by malignancy or rib surgery due to malignancy, radiation therapy, COPD, coughing
- Inability to follow procedures or insufficient knowledge of language (German/French) or impaired communication or inability to give consent
- Patients who have clearly stated that they would not agree in providing their clinical data for scientific purposes
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Thoracic Surgery, University Hospital Basel
Basel, 4031
About this study
The main study objective is to evaluate the long-term outcome in a prospective follow-up visit of patients who underwent hardware removal after surgical stabilization of rib fractures (SSRF) after a blunt chest trauma .
Read the detailed description
Potential of surgical stabilization of rib fractures (SSRF) to improve clinical outcomes in patients has been demonstrated with increasing interest of surgeons in this procedure and indications for SSRF expanding. Some reports found signals for hardware removal after SSRF such as hardware failure, infections and persisting pain. There is currently lack of studies collecting systematically long-term outcomes after SSRF hardware removal. For that reason, this project presents the retrospective case series of patients with removal of osteosynthetic material after rib stabilisation treated at Department of Thoracic Surgery of the University Hospital Basel (USB). The recovery of these patients will be reviewed and a prospective evaluation of long-term outcomes will be done. The aim is to provide an insight and implications for treatment strategies of future patients. Most of the collected patient data are retrospective data. One prospective follow-up visit inclusive a health survey per patient will be performed.
- Conditions
- Rib Fractures
- Being tested
- Data collection on patient reported long-term outcome of SSRF hardware removal
- Keywords
- surgical stabilization of rib fractures (SSRF), hardware failure, hardware-related complications, hardware removal, blunt chest trauma, rib osteosynthesis
- Medical subject headings
- Rib Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collection on patient reported long-term outcome of SSRF hardware removalOther
One prospective follow-up visit will be performed. On this visit the patient reported long-term outcome will be documented through a health survey.
| Study group | Role | What they receive |
|---|---|---|
| Surgical stabilization of rib fractures (SSRF) and subsequent hardware removal | Patients treated at the Department of Thoracic Surgery at the University Hospital Basel between 01.09.2017 and start date Remove Study with a diagnosis of rib fracture and with surgical stabilization of rib fracture and subsequent hardware removal will be identified. Receives: Other: Data collection on patient reported long-term outcome of SSRF hardware removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health survey of long-term outcome after hardware removal (Quality of life assessment)
The questions are formulated as an adapted question set of the EQ-5D-5L Dimension (EQ-5D-5L) questionnaire followed by additional study specific questions. A numerical rating scale (NRS) will be used for evaluation from 0 - 10. In addition, the patient will be asked to rate the condition now compared to before hardware removal in four categories (less good, no change, slightly better, much better). The analysis of the project data will be done descriptive.
Measured: One time assessment at baseline (prospective Follow up-visit)
Secondary outcomes (6)
Number of removed hardware
Number of removed hardware and affected ribs (retrospective analyses)
Measured: Up to 3 years until prospective Follow up-visit
Number of broken and fixed ribs
Number of broken and fixed ribs with used hardware (retrospective analyses)
Measured: Up to 3 years until prospective Follow up-visit
Interval between SSRF and hardware removal
Interval between SSRF and hardware removal (retrospective analyses)
Measured: Up to 3 years until prospective Follow up-visit
Interval between SSRF and follow-up visit
Interval between SSRF and follow-up visit (retrospective analyses)
Measured: Up to 3 years until prospective Follow up-visit
Occurrence of significant complications during and 30 days after SSRF hardware removal
Occurrence of significant complications during and 30 days after SSRF hardware removal (retrospective analyses)
Measured: Up to 3 years until prospective Follow up-visit
Surgical indication for hardware removal
Surgical indication for hardware removal
Measured: Up to 3 years until prospective Follow up-visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start4 Aug 2023
- Primary completion8 Jan 2024
- Study completion8 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rib FracturesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Stepankova, MD, Principal investigator, Department of Thoracic Surgery, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06003595
- Sponsor's protocol ID
- 2023-01191; kt23Lardinois3
- Other IDs
- 2023
- Acronym
- REMOVE
- Status last verified
- May 2025
- First submitted
- 18 Jul 2023
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Svec MB, Bachmann H, Hojski A, Macharia-Nimietz EF, Dackam SVC, Lardinois D. Long-term outcomes after removal of rib stabilization hardware in patients with blunt chest trauma. Eur J Trauma Emerg Surg. 2025 Apr 29;51(1):187. doi: 10.1007/s00068-025-02858-y.
PubMed 40299046
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Outcome After Removal of Rib Stabilization Hardware in Patients With Blunt Chest Trauma
- ClinicalTrials.gov ID
- NCT06003595
- Acronym / sponsor ID
- REMOVE / 2023-01191; kt23Lardinois3
- Conditions
- Rib Fractures
- Keywords
- surgical stabilization of rib fractures (SSRF), hardware failure, hardware-related complications, hardware removal, blunt chest trauma, rib osteosynthesis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 4 Aug 2023 (actual)
- Primary completion
- 8 Jan 2024 (actual)
- Study completion
- 8 Jan 2024 (actual)
- First posted
- 22 Aug 2023 (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 main study objective is to evaluate the long-term outcome in a prospective follow-up visit of patients who underwent hardware removal after surgical stabilization of rib fractures (SSRF) after a blunt chest trauma .
Detailed description
Potential of surgical stabilization of rib fractures (SSRF) to improve clinical outcomes in patients has been demonstrated with increasing interest of surgeons in this procedure and indications for SSRF expanding. Some reports found signals for hardware removal after SSRF such as hardware failure, infections and persisting pain. There is currently lack of studies collecting systematically long-term outcomes after SSRF hardware removal. For that reason, this project presents the retrospective case series of patients with removal of osteosynthetic material after rib stabilisation treated at Department of Thoracic Surgery of the University Hospital Basel (USB). The recovery of these patients will be reviewed and a prospective evaluation of long-term outcomes will be done. The aim is to provide an insight and implications for treatment strategies of future patients. Most of the collected patient data are retrospective data. One prospective follow-up visit inclusive a health survey per patient will be performed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical stabilization of rib fractures (SSRF) and subsequent hardware removal | – | Other: Data collection on patient reported long-term outcome of SSRF hardware removalPatients treated at the Department of Thoracic Surgery at the University Hospital Basel between 01.09.2017 and start date Remove Study with a diagnosis of rib fracture and with surgical stabilization of rib fracture and subsequent hardware removal will be identified. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with blunt chest trauma who underwent hardware removal after rib stabilisation between September 01, 2017 and September 30, 2023. The patients received hardware implantation and hardware removal at the Department of Thoracic Surgery of the University Hospital Basel.
Key inclusion criteria (9 listed)
- Patient treated at the Department of Thoracic Surgery, USB for implantation and removal of rib fixation hardware
- Blunt chest trauma/injuries to the thorax: Patient with blunt chest trauma (with or without polytrauma) before SSRF implantation and subsequent hardware removal
- Rib fracture: At least one rib fracture (unilateral and/or bilateral incl. flail chest) on radiography chest imaging on time of SSRF implantation. Patients with rib fracture/non-union due to pseudoarthrosis are included.
- Rib fixation material implantation and removal: Patient underwent surgery for rib fracture and implantation of at least one (partially or complete) rib fixation material (at any time point) with later hardware removal (partially or complete) (at any time point between 01.09.2017 and 30.09.2023)
- Patient of all gender
Key exclusion criteria (10 listed)
- Patients who received re-osteosynthesis on the same day as hardware removal
- Patients received conservative therapy or surgery with absorbable plates
- On hardware implantation:
- Inability to follow procedures or insufficient knowledge of language (German/French) or impaired communication or inability to give consent
- Patients who have clearly stated that they would not agree in providing their clinical data for scientific purposes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collection on patient reported long-term outcome of SSRF hardware removalOne prospective follow-up visit will be performed. On this visit the patient reported long-term outcome will be documented through a health survey. | Other | Surgical stabilization of rib fractures (SSRF) and subsequent hardware removal |
Primary outcome
Health survey of long-term outcome after hardware removal (Quality of life assessment)
Time frame: One time assessment at baseline (prospective Follow up-visit)
The questions are formulated as an adapted question set of the EQ-5D-5L Dimension (EQ-5D-5L) questionnaire followed by additional study specific questions. A numerical rating scale (NRS) will be used for evaluation from 0 - 10. In addition, the patient will be asked to rate the condition now compared to before hardware removal in four categories (less good, no change, slightly better, much better). The analysis of the project data will be done descriptive.
6 secondary outcomes
Number of removed hardware
Time frame: Up to 3 years until prospective Follow up-visit
Number of broken and fixed ribs
Time frame: Up to 3 years until prospective Follow up-visit
Interval between SSRF and hardware removal
Time frame: Up to 3 years until prospective Follow up-visit
Interval between SSRF and follow-up visit
Time frame: Up to 3 years until prospective Follow up-visit
Occurrence of significant complications during and 30 days after SSRF hardware removal
Time frame: Up to 3 years until prospective Follow up-visit
Surgical indication for hardware removal
Time frame: Up to 3 years until prospective Follow up-visit
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 11 May 2025.
- Results publication: PubMed 40299046Svec MB, Bachmann H, Hojski A, Macharia-Nimietz EF, Dackam SVC, Lardinois D. Long-term outcomes after removal of rib stabilization hardware in patients with blunt chest trauma. Eur J Trauma Emerg Surg. 2025 Apr 29;51(1):187. doi: 10.1007/s00068-025-02858-y.
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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.
Maria Stepankova, MD principal investigator
Department of Thoracic Surgery, University Hospital Basel
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 Rib Fractures, 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 9 inclusion and 10 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 11 May 2025. 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?
Health survey of long-term outcome after hardware removal (Quality of life assessment) (time frame: One time assessment at baseline (prospective Follow up-visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06003595, which also lists 1 linked publication.
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 11 May 2025.