Rib FracturesCARENCT06405841
Costal Fracture Assessment for Relief and Enhancement of Quality of Life
An observational study of Rib Fractures and Rib Trauma, run by Ospedali Riuniti Trieste at 4 sites in Italy.
Trial summary
This study explores the impact of rib fractures on patient well-being and quality of life, aiming to identify effective interventions for pain relief and functional improvement. It investigates the long-term outcomes of conservative treatment for rib fractures, analyzing factors such as analgesic therapy… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rib Fractures, Rib Trauma
- What is being tested?
- Survey and Pain management
- How many people
- 950 participants
- Where
- 4 sitesItaly
- Study dates
- Jan 2025to Jan 2027
- 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: all patients with rib fractures matching inclusion and exclusion criteria will be involved in the study
Who may be able to join
- Patients with rib fractures
Who cannot join
- cognitive impairment
- chronic pain due to pathologic fractures
- active cancer
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy4 sites
Emergency Department
Trieste, Italy, 34149
Entiola Celaj
Laura Giordano
Intensive Care Unit
Trieste, Italy, 34149
Sabina Gerebizza
Lucia Comuzzi
Department of General Surgery
Trieste, TS, 34149
Manuela Mastronardi, MD, 0403994152 ext. 0039, manuela.mastronardi@gmail.com
Alan Biloslavo, MD
Department of Thoracic Surgery
Trieste, TS, 34149
Marina Troian, MD
Stefano Lovadina
About this study
Official title: Costal Fracture Assessment for Relief and Enhancement of Quality of Life - CARE Study
This study explores the impact of rib fractures on patient well-being and quality of life, aiming to identify effective interventions for pain relief and functional improvement. It investigates the long-term outcomes of conservative treatment for rib fractures, analyzing factors such as analgesic therapy, hospitalization duration, and respiratory infection rates. Anticipated results include a comprehensive assessment of patient quality of life and the potential translational implications for healthcare practice. Furthermore, the study aims to inform healthcare resource optimization, potentially guiding treatment decisions and improving patient outcomes within the National Health Service.
Read the detailed description
Thoracic trauma remains a significant cause of morbidity and mortality in the traumatized population. Rib fractures are the most commonly encountered injuries after thoracic trauma, accounting for approximately 10-15% of all trauma-related hospital admissions. Fractured ribs serve as surrogate indicators of severe injuries, as most patients suffer additional critical injuries. Rib fractures are associated with significant long-term morbidity and disability, resulting in enduring physical impairment, dyspnea, and delayed return to normal daily and work activities, leading to decreased quality of life. Additionally, previous studies have demonstrated that up to a quarter of patients with rib fractures experience persistent chest pain even one year or more after the trauma. In current clinical practice, surgical treatment of rib fractures is increasingly common, as restoring chest wall integrity appears to alleviate pain and preserve normal breathing mechanics. While recent studies suggest that rib fracture fixation may improve lung function, reduce (pulmonary) complication rates, and shorten hospitalization and intensive care unit (ICU) stays in selected patients, a definitive consensus on which patients should undergo surgery has yet to be established. Contributing to the difficulty in determining optimal treatment for patients with rib fractures is the limited research on long-term quality of life and functional outcomes after rib fracture fixation or conservative management. Therefore, this study aims to investigate the quality of life of patients with rib fractures treated conservatively using a dedicated questionnaire and evaluate the type of analgesic medical therapy used, length of hospital stay, and rate of respiratory infections.
Expected Results, Translatability, and Impact on the National Health Service (SSN):
Expected Results: It is anticipated that the study will provide a detailed assessment of the quality of life of patients with rib fractures treated conservatively and their long-term quality of life. Additionally, the study aims to identify the most effective types of analgesic medical therapies in controlling rib fracture-related pain, as well as the duration of hospitalization and rate of respiratory infections associated with conservative treatment.
Translatability: The study results could have broad practical applications in the healthcare sector, providing guidance on best practices for rib fracture treatment. This could lead to greater efficacy in rib fracture management protocols, reducing or increasing the need for surgical interventions to improve patient quality of life.
Impact on the National Health Service (SSN): The study could have a significant impact on the SSN by providing evidence to optimize healthcare resources through more targeted management of rib fractures. If the results demonstrate that conservative treatment is ineffective for certain types of rib fractures, as it entails a longer hospital stay with very late return to daily and work activities, these patients could be selected for surgical treatment, resulting in savings for the SSN and an improvement in patient quality of life.
- Conditions
- Rib Fractures, Rib Trauma
- Being tested
- Survey, Pain management
- Medical subject headings
- Rib Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
All patients will be asked to complete a survey at 1, 2, 4, 12 and 24 weeks from the trauma to assess their quality of life
Pain managementOther
All patients will be asked about their pain management at 1, 2, 4, 12 and 24 weeks from the trauma to assess if they are under medication and what kind of medication are they taking
| Study group | Role | What they receive |
|---|---|---|
| Patients with rib fractures | Patients with rib fractures that correspond to inclusion and exclusion criteria Receives: Other: Survey; Other: Pain management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to achieve daily living activities (yes/no)
the ability to achieve daily living activities will be measured using a specific survey
Measured: 1, 2, 4, 12 and 24 weeks from the trauma
Secondary outcomes (3)
Pain killers assumption
evaluation of pain killers assumption (yes/no)
Measured: 1, 2, 4, 12 and 24 weeks from the trauma
Respiratory infection rate
Incidence of respiratory infection in patients with rib fractures
Measured: 1, 2, 4, 12 and 24 weeks from the trauma
Lenght of stay
Lenght of hospitalization in days
Measured: to 2 years after the trauma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study startJan 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
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.
- 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
- 950 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedali Riuniti Trieste
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuela Mastronardi, Ospedali Riuniti Trieste
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06405841
- Sponsor's protocol ID
- 345_2024H
- Acronym
- CARE
- Status last verified
- Nov 2024
- First submitted
- 4 May 2024
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mastronardi M, Troian M, Germani P, Lovadina S, de Manzini N, Celaj E, Biloslavo A. Costal fracture assessment for relief and enhancement of quality of life-CARE study. Eur J Trauma Emerg Surg. 2025 Jan 9;51(1):3. doi: 10.1007/s00068-024-02689-3.
PubMed 39786597
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Costal Fracture Assessment for Relief and Enhancement of Quality of Life - CARE Study
- ClinicalTrials.gov ID
- NCT06405841
- Acronym / sponsor ID
- CARE / 345_2024H
- Conditions
- Rib Fractures, Rib Trauma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 950 participants (estimated)
- Lead sponsor
- Ospedali Riuniti TriesteUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 9 May 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.
This study explores the impact of rib fractures on patient well-being and quality of life, aiming to identify effective interventions for pain relief and functional improvement. It investigates the long-term outcomes of conservative treatment for rib fractures, analyzing factors such as analgesic therapy, hospitalization duration, and respiratory infection rates. Anticipated results include a comprehensive assessment of patient quality of life and the potential translational implications for healthcare practice. Furthermore, the study aims to inform healthcare resource optimization, potentially guiding treatment decisions and improving patient outcomes within the National Health Service.
Detailed description
Thoracic trauma remains a significant cause of morbidity and mortality in the traumatized population. Rib fractures are the most commonly encountered injuries after thoracic trauma, accounting for approximately 10-15% of all trauma-related hospital admissions. Fractured ribs serve as surrogate indicators of severe injuries, as most patients suffer additional critical injuries. Rib fractures are associated with significant long-term morbidity and disability, resulting in enduring physical impairment, dyspnea, and delayed return to normal daily and work activities, leading to decreased quality of life. Additionally, previous studies have demonstrated that up to a quarter of patients with rib fractures experience persistent chest pain even one year or more after the trauma. In current clinical practice, surgical treatment of rib fractures is increasingly common, as restoring chest wall integrity appears to alleviate pain and preserve normal breathing mechanics. While recent studies suggest that rib fracture fixation may improve lung function, reduce (pulmonary) complication rates, and shorten hospitalization and intensive care unit (ICU) stays in selected patients, a definitive consensus on which patients should undergo surgery has yet to be established. Contributing to the difficulty in determining optimal treatment for patients with rib fractures is the limited research on long-term quality of life and functional outcomes after rib fracture fixation or conservative management. Therefore, this study aims to investigate the quality of life of patients with rib fractures treated conservatively using a dedicated questionnaire and evaluate the type of analgesic medical therapy used, length of hospital stay, and rate of respiratory infections.
Expected Results, Translatability, and Impact on the National Health Service (SSN):
Expected Results: It is anticipated that the study will provide a detailed assessment of the quality of life of patients with rib fractures treated conservatively and their long-term quality of life. Additionally, the study aims to identify the most effective types of analgesic medical therapies in controlling rib fracture-related pain, as well as the duration of hospitalization and rate of respiratory infections associated with conservative treatment.
Translatability: The study results could have broad practical applications in the healthcare sector, providing guidance on best practices for rib fracture treatment. This could lead to greater efficacy in rib fracture management protocols, reducing or increasing the need for surgical interventions to improve patient quality of life.
Impact on the National Health Service (SSN): The study could have a significant impact on the SSN by providing evidence to optimize healthcare resources through more targeted management of rib fractures. If the results demonstrate that conservative treatment is ineffective for certain types of rib fractures, as it entails a longer hospital stay with very late return to daily and work activities, these patients could be selected for surgical treatment, resulting in savings for the SSN and an improvement in patient quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with rib fractures | – | Other: Survey, Other: Pain managementPatients with rib fractures that correspond to inclusion and exclusion criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all patients with rib fractures matching inclusion and exclusion criteria will be involved in the study
Key inclusion criteria (1 listed)
- Patients with rib fractures
Key exclusion criteria (3 listed)
- cognitive impairment
- chronic pain due to pathologic fractures
- active cancer
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 |
|---|---|---|
| SurveyAll patients will be asked to complete a survey at 1, 2, 4, 12 and 24 weeks from the trauma to assess their quality of life | Other | Patients with rib fractures |
| Pain managementAll patients will be asked about their pain management at 1, 2, 4, 12 and 24 weeks from the trauma to assess if they are under medication and what kind of medication are they taking | Other | Patients with rib fractures |
Primary outcome
Ability to achieve daily living activities (yes/no)
Time frame: 1, 2, 4, 12 and 24 weeks from the trauma
the ability to achieve daily living activities will be measured using a specific survey
3 secondary outcomes
Pain killers assumption
Time frame: 1, 2, 4, 12 and 24 weeks from the trauma
Respiratory infection rate
Time frame: 1, 2, 4, 12 and 24 weeks from the trauma
Lenght of stay
Time frame: to 2 years after the trauma
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 21 Nov 2024.
- Derived from this study: PubMed 39786597Mastronardi M, Troian M, Germani P, Lovadina S, de Manzini N, Celaj E, Biloslavo A. Costal fracture assessment for relief and enhancement of quality of life-CARE study. Eur J Trauma Emerg Surg. 2025 Jan 9;51(1):3. doi: 10.1007/s00068-024-02689-3.
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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.
4 sites 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 Rib Trauma, run by Ospedali Riuniti Trieste at 4 sites in Italy.
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 1 inclusion and 3 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: opening soon, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. 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?
Contact Alan Biloslavo, MD (+390403994152, alan.biloslavo@asugi.sanita.fvg.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability to achieve daily living activities (yes/no) (time frame: 1, 2, 4, 12 and 24 weeks from the trauma). 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 NCT06405841, 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 21 Nov 2024.