Rib FracturesNCT06788067
Impact of Time Interval Between Trauma and Operation on Clinical Outcome in Patients With Delayed Rib Fixation (Nonunion)
An observational study of Rib Fractures and Nonunion of Fracture, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The goal of this monocentric observational study is to evaluate the outcomes of patients who underwent a delayed surgical stabilization of rib fractures/surgical stabilization of rib fracture nonunion (SSRFN) based on the timing of surgery after trauma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rib Fractures, Nonunion of Fracture
- How many people
- 41 participants
- Where
- 1 siteSwitzerland
- Study dates
- 13 Jan 2025to Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Approximately 75-80, patients who underwent rib fixation later than 3 weeks after trauma at the Department of Thoracic Surgery of the University Hospital Basel between 2012 and end of June 2024
Who may be able to join
- Patients who signed the study specific consent form
- Patients aged ≥18 years at the time of informed consent
- Patients who provided written informed consent in accordance with ICH-GCP regulations prior to participating any protocol-specific follow-up
- Patients with at least one rib fracture caused by trauma (traffic accident, falls), surgery (cardiac, thoracic, lung transplantation), sports, cough, and cardiopulmonary resuscitation
Who cannot join
- Patients who were treated conservatively
- Patients who underwent rib fixation till 3 weeks after trauma
- Patients who underwent SSRF prior to SSRFN
- Patients who are unable to follow the procedures of the study, e. g. have insufficient knowledge of German or French languages, psychological disorders, dementia etc.
- Patients with a pathological rib fracture(s) due to malignancy or radiation
- Participation in any interventional study in our department that might influence any of the outcome parameters
- Patients who underwent an initial surgery of rib fracture prior to development of a rib fracture nonunion
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Thoracic Surgery, University Hospital Basel
Basel, Canton of Basel-City, 4031
About this study
The goal of this monocentric observational study is to evaluate the outcomes of patients who underwent a delayed surgical stabilization of rib fractures/surgical stabilization of rib fracture nonunion (SSRFN) based on the timing of surgery after trauma.
Read the detailed description
Rib fractures occur in a significant number of patients with blunt chest trauma, and while conservative treatment remains the standard, surgical stabilization of rib fractures (SSRF) has shown improved clinical outcomes. However, conservative therapy often results in chronic chest pain and long-term incapacity, with up to 64% of patients experiencing persistent pain. Additionally, rib fracture nonunion, a condition where the bone fails to heal, affects approximately 12-15% of cases treated conservatively and can lead to long-term complications, including pain, limited mobility, and impaired quality of life.
This single-center observational study aims to analyze the outcomes of patients who underwent delayed SSRF (surgery between 3 weeks and 3 months after trauma) or nonunion SSRF (surgery performed more than 3 months after trauma). To assess whether a shorter interval between trauma and surgery results in better outcomes, the primary objective is to assess the persistence of thoracic pain in both patient groups. The secondary objective is to determine if SSRF improved patients' well-being.
This prospective research project is a single center analysis of existing data on patients, who underwent rib fixation for nonunion at the Department of Thoracic Surgery of the University Hospital Basel between January 1st, 2012 and June 30th, 2024. A prospective follow-up visit will be organized to assess the postoperative outcome.
The results of this study will provide valuable insights into optimizing treatment timelines for non consolidated rib fractures or rib fracture nonunion, improving patient outcomes and reducing long-term pain and disability.
- Conditions
- Rib Fractures, Nonunion of Fracture
- Keywords
- Surgical stabilization of rib fractures (SSRF), Delayed SSRF, Nonunion SSRF
- Medical subject headings
- Rib Fractures, Fractures, Ununited
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Delayed SSRF | Patients who underwent surgery between 3 weeks and 3 months after trauma | |
| Nonunion SSRF | Patients who underwent surgery more than 3 months after trauma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain status at Follow-up (FU)
The pain status at the timepoint of the follow-up visit is measured using the numeric rating scale (NRS, scale 0: no pain to 10: worst pain) in different situations (at rest, at movement, and during deep inspiration). The type of pain (local, diffuse, neurogenic) will be also assessed.
Measured: After surgery at follow-up visit (1-8 weeks after recruitment)
Recommendation of the surgery to another person in a situation like the own
The patients will be asked if they would recommend the surgery to another person in a situation like the own. The assessment will be performed in two categories: yes/no.
Measured: After surgery at follow-up visit (1-8 weeks after recruitment)
Pain status at FU compared to before surgery
The pain status at the timepoint of the follow-up visit compared to the timepoint before surgery in five distinct categories on a Likert-scale (much better, slightly better, no change, slightly worse, much worse).
Measured: After surgery at follow-up visit (1-8 weeks after recruitment)
Painkiller Use (including nonsteroidal anti-inflammatory drugs and opioids)
The painkiller use including nonsteroidal anti-inflammatory drugs and opioids is being recorded.
Measured: After surgery at follow-up visit (1-8 weeks after recruitment)
Secondary outcomes (10)
Health status
The subjective health-related quality of life is recorded using the 12-Item Short-Form (SF-12) questionnaire. The SF-12 is a validated scale used to assess physical and mental health, with scores ranging from 0 to 100, where higher scores indicate better health and well-being.
Measured: After surgery at follow-up visit (1-8 weeks after recruitment)
Resumption of daily/professional activity at FU
Resumption of former professional activity and daily activities will be assessed by use of the numeric rating scale (NRS, scale 0: no pain to 10: worst pain).
Measured: After surgery at follow-up visit (1-8 weeks after recruitment)
Resumption of daily/professional activity at FU compared to before surgery
Resumption of former professional activity and daily activities will be assessed by comparison with the situation before trauma and before surgery (much better, slightly better, no change, slightly worse, much worse).
Measured: After surgery at follow-up visit (1-8 weeks after recruitment)
Complications
Complications related to surgery until/at 30 d after surgery according to the Clavien-Dindo classification.
Measured: Day 30 after surgery
Correlation between Number of Broken Ribs, Fixed Ribs, and Impact on Patient Outcomes
This outcome assesses the relationship between the number of broken ribs, the number of surgically fixed ribs, and their influence on patient recovery and clinical outcomes.
Measured: After surgery at follow-up visit (1-8 weeks after recruitment)
Association between Age and clinical outcomes
This outcome measures the association between patient age and the clinical outcomes following rib fractures.
Measured: After surgery at follow-up visit (1-8 weeks after recruitment)
Impact of Gender and Clinical Outcomes
This outcome measures the impact of patient's gender and clinical outcomes following rib fractures
Measured: After surgery at follow-up visit (1-8 weeks after recruitment)
Impact of Rib Fracture Localization on Clinical Outcomes
This outcome measures the impact of the location of rib fractures on clinical outcomes.
Measured: After surgery at follow-up visit (1-8 weeks after recruitment)
Frequency of Risk Factors for Rib Fracture Nonunion
Frequency of risk factors for nonunion like nicotine use, diabetes mellitus, medication use including nonsteroidal anti-inflammatory drugs and opioids, osteoporosis, hypothyroidism.
Measured: After surgery at follow-up visit (1-8 weeks after recruitment)
Physical examination
The incidence of chest wall instability and persistent clicking is assessed at the FU visit by a physical examination.
Measured: After surgery at follow-up visit (1-8 weeks after recruitment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start13 Jan 2025
- Primary completion4 Aug 2025
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Svec, Principal investigator, Department of Thoracic Surgery, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06788067
- Sponsor's protocol ID
- 2024-02144; kt25Lardinois
- Status last verified
- Aug 2025
- First submitted
- 10 Jan 2025
- Last updated
- 7 Aug 2025
- 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 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Time Interval Between Trauma and Operation on Clinical Outcome in Patients With Delayed Rib Fixation (Nonunion)
- ClinicalTrials.gov ID
- NCT06788067
- Acronym / sponsor ID
- 2024-02144; kt25Lardinois
- Conditions
- Rib Fractures, Nonunion of Fracture
- Keywords
- Surgical stabilization of rib fractures (SSRF), Delayed SSRF, Nonunion SSRF
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 13 Jan 2025 (actual)
- Primary completion
- 4 Aug 2025 (actual)
- Study completion
- Feb 2026 (estimated)
- First posted
- 22 Jan 2025 (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 goal of this monocentric observational study is to evaluate the outcomes of patients who underwent a delayed surgical stabilization of rib fractures/surgical stabilization of rib fracture nonunion (SSRFN) based on the timing of surgery after trauma.
Detailed description
Rib fractures occur in a significant number of patients with blunt chest trauma, and while conservative treatment remains the standard, surgical stabilization of rib fractures (SSRF) has shown improved clinical outcomes. However, conservative therapy often results in chronic chest pain and long-term incapacity, with up to 64% of patients experiencing persistent pain. Additionally, rib fracture nonunion, a condition where the bone fails to heal, affects approximately 12-15% of cases treated conservatively and can lead to long-term complications, including pain, limited mobility, and impaired quality of life.
This single-center observational study aims to analyze the outcomes of patients who underwent delayed SSRF (surgery between 3 weeks and 3 months after trauma) or nonunion SSRF (surgery performed more than 3 months after trauma). To assess whether a shorter interval between trauma and surgery results in better outcomes, the primary objective is to assess the persistence of thoracic pain in both patient groups. The secondary objective is to determine if SSRF improved patients' well-being.
This prospective research project is a single center analysis of existing data on patients, who underwent rib fixation for nonunion at the Department of Thoracic Surgery of the University Hospital Basel between January 1st, 2012 and June 30th, 2024. A prospective follow-up visit will be organized to assess the postoperative outcome.
The results of this study will provide valuable insights into optimizing treatment timelines for non consolidated rib fractures or rib fracture nonunion, improving patient outcomes and reducing long-term pain and disability.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delayed SSRF | – | –Patients who underwent surgery between 3 weeks and 3 months after trauma |
| Nonunion SSRF | – | –Patients who underwent surgery more than 3 months after trauma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 75-80, patients who underwent rib fixation later than 3 weeks after trauma at the Department of Thoracic Surgery of the University Hospital Basel between 2012 and end of June 2024
Key inclusion criteria (4 listed)
- Patients who signed the study specific consent form
- Patients aged ≥18 years at the time of informed consent
- Patients who provided written informed consent in accordance with ICH-GCP regulations prior to participating any protocol-specific follow-up
- Patients with at least one rib fracture caused by trauma (traffic accident, falls), surgery (cardiac, thoracic, lung transplantation), sports, cough, and cardiopulmonary resuscitation
Key exclusion criteria (7 listed)
- Patients who were treated conservatively
- Patients who underwent rib fixation till 3 weeks after trauma
- Patients who underwent SSRF prior to SSRFN
- Patients who are unable to follow the procedures of the study, e. g. have insufficient knowledge of German or French languages, psychological disorders, dementia etc.
- Patients with a pathological rib fracture(s) due to malignancy or radiation
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
Pain status at Follow-up (FU)
Time frame: After surgery at follow-up visit (1-8 weeks after recruitment)
The pain status at the timepoint of the follow-up visit is measured using the numeric rating scale (NRS, scale 0: no pain to 10: worst pain) in different situations (at rest, at movement, and during deep inspiration). The type of pain (local, diffuse, neurogenic) will be also assessed.
Recommendation of the surgery to another person in a situation like the own
Time frame: After surgery at follow-up visit (1-8 weeks after recruitment)
The patients will be asked if they would recommend the surgery to another person in a situation like the own. The assessment will be performed in two categories: yes/no.
Pain status at FU compared to before surgery
Time frame: After surgery at follow-up visit (1-8 weeks after recruitment)
The pain status at the timepoint of the follow-up visit compared to the timepoint before surgery in five distinct categories on a Likert-scale (much better, slightly better, no change, slightly worse, much worse).
Painkiller Use (including nonsteroidal anti-inflammatory drugs and opioids)
Time frame: After surgery at follow-up visit (1-8 weeks after recruitment)
The painkiller use including nonsteroidal anti-inflammatory drugs and opioids is being recorded.
10 secondary outcomes
Health status
Time frame: After surgery at follow-up visit (1-8 weeks after recruitment)
Resumption of daily/professional activity at FU
Time frame: After surgery at follow-up visit (1-8 weeks after recruitment)
Resumption of daily/professional activity at FU compared to before surgery
Time frame: After surgery at follow-up visit (1-8 weeks after recruitment)
Complications
Time frame: Day 30 after surgery
Correlation between Number of Broken Ribs, Fixed Ribs, and Impact on Patient Outcomes
Time frame: After surgery at follow-up visit (1-8 weeks after recruitment)
Association between Age and clinical outcomes
Time frame: After surgery at follow-up visit (1-8 weeks after recruitment)
Impact of Gender and Clinical Outcomes
Time frame: After surgery at follow-up visit (1-8 weeks after recruitment)
Impact of Rib Fracture Localization on Clinical Outcomes
Time frame: After surgery at follow-up visit (1-8 weeks after recruitment)
Frequency of Risk Factors for Rib Fracture Nonunion
Time frame: After surgery at follow-up visit (1-8 weeks after recruitment)
Physical examination
Time frame: After surgery at follow-up visit (1-8 weeks after recruitment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
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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 Svec 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 and Nonunion of Fracture, 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 7 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: under way, not looking for participants, as of the sponsor's last update on 7 Aug 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?
This study is still under way. Results are not available in the source record yet.
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?
Pain status at Follow-up (FU) (time frame: After surgery at follow-up visit (1-8 weeks after recruitment)). 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 7 Aug 2025; AzTrials last refreshed its copy on 7 Nov 2026.