Rib FracturesNCT04104932
Surgical and Conservative Treatment in Isolated Minor Rib Fractures
An observational study of Rib Fractures, run by Taipei Medical University Shuang Ho Hospital.
Trial summary
The purpose of this research is to compare the outcomes of surgical stabilization and conservative treatment in patients with isolated minor rib fractures. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Rib Fractures
- What is being tested?
- Open reduction and internal fixation
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jul 2019to 30 Oct 2023
- How long will I take part?
- 3 Months
- 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 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with isolated minor rib fractures
Who may be able to join
- Patient age ≥ 20 years old.
- Patient was diagnosed with isolated minor rib fractures by thoracic surgeon.
- Patient was suitable for both surgical stabilization and conservative treatment.
Who cannot join
- Severe trauma associated to other systems.
- Pathologic fractures: such as fracture due to metastasis or steroid therapy.
- Unconsciousness or disturbed conscious level.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of the Outcomes of Surgical Stabilization and Conservative Treatment in Patients With Isolated Minor Rib Fractures: A Prospective Observational Cohort Study.
The purpose of this research is to compare the outcomes of surgical stabilization and conservative treatment in patients with isolated minor rib fractures.
Read the detailed description
Isolated minor rib fractures (IMRFs), which is defined by single or two isolated minor rib fractures caused by trauma or stress. Traditionally, rib fractures are managed mainly by surgical stabilization or conservative treatment. In 2018, a systemic review and meta-analysis for patients with multiple rib fractures had revealed a shorter duration of mechanical ventilation, shorter hospital length of stay, and fewer trauma-associated complications in the surgical group than in the non-surgical group. In contrast, IMRFs are seldom life threatening, and compared to extremity fractures, rib fractures do not require matching accurately. Thus, IMRFs are usually treated conservatively. However, the investigators have clinically observed that patients suffering severe pain due to progressive rib displacement may take longer to return to normal activity, have lower quality of life, and even an increased risk of complications. Moreover, limited studies discussed the efficacy of surgical interventions for IMRFs. Therefore, the investigators conduct a prospective observational cohort study to compare the outcomes of surgical stabilization and conservative treatment in patients with IMRFs. The investigators collect patients with IMRFs whose situation were both suitable for surgical and non-surgical interventions. After explanation, patients can decide to undergo conservative or surgical treatment by themselves. The investigators will follow up pain scores, chest X-ray, pulmonary function tests, and duration of return to normal activity. Those data will be statistically analyzed by two-tailed two-sample t-test. This prospective cohort study is supposed to provide more evidence for clinical decision making and optimal management of IMRFs.
- Conditions
- Rib Fractures
- Being tested
- Open reduction and internal fixation
- Keywords
- surgical stabilization, conservative treatment
- Medical subject headings
- Rib Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open reduction and internal fixationProcedure or surgery
Open reduction and internal fixation
| Study group | Role | What they receive |
|---|---|---|
| Surgical group | Patients with isolated minor rib fractures received surgical stabilization. Receives: Procedure: Open reduction and internal fixation | |
| Conservative group | Patients with isolated minor rib fractures received conservative treatment, such as NSAIDs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of return to normal activity
From day of injury to day of return to normal activity
Measured: 3 months after operation or after injury
Pain score change at 1 week
Pain Visual analog scales (Pain VAS) to measure pain intensity. A 10 cm horizontal line will be shown and patients mark on the line representing their perception of their current state. The score range from 0 to 10, with following cutpoints: no pain (0 cm), mild pain(1-4 cm), moderate pain (5-7 cm), and severe pain (8-10 cm).
Measured: Change from injury or operation at 1 week
Pain score change at 3 months
Pain Visual analog scales (Pain VAS) to measure pain intensity. A 10 cm horizontal line will be shown and patients mark on the line representing their perception of their current state. The score range from 0 to 10, with following cutpoints: no pain (0 cm), mild pain(1-4 cm), moderate pain (5-7 cm), and severe pain (8-10 cm).
Measured: Change from injury or operation at 3 months
Secondary outcomes (5)
Forced vital capacity (FVC) change
Pulmonary function testing with spirometry, using percent of the predicted value (%)
Measured: Change from injury or operation at 3 months
Forced expiratory volume in the first second (FEV1) change
Pulmonary function testing with spirometry, using percent of the predicted value (%)
Measured: Change from injury or operation at 3 months
Total lung capacity (TLC) change
Pulmonary function testing with spirometry, using percent of the predicted value (%)
Measured: Change from injury or operation at 3 months
Peak expiratory flow (PEF) change
Pulmonary function testing with spirometry, in unit of liters per minute
Measured: Change from injury or operation at 3 months
36-Item Short Form Survey (SF-36) results
Quality of life will be evaluated via SF-36 questionnaire, and will be scored according to SF-36 scoring rules
Measured: At 3 months after injury or operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study startJul 2019 (estimated)
- Primary completion14 Jul 2023 (estimated)
- Study completion30 Oct 2023 (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
- 120 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Shuang Ho Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tung-Yu, Tiong, Taipei Medical University Shuang Ho Hospital
- Investigators
- Tung-Yu Tiong, MD, Principal investigator, Taipei Medical University Shuang Ho Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04104932
- Sponsor's protocol ID
- N201903152
- Status last verified
- Sep 2019
- First submitted
- 28 Jun 2019
- Last updated
- 26 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: as required
Publications
Liang YS, Yu KC, Wong CS, Kao Y, Tiong TY, Tam KW. Does Surgery Reduce the Risk of Complications Among Patients with Multiple Rib Fractures? A Meta-analysis. Clin Orthop Relat Res. 2019 Jan;477(1):193-205. doi: 10.1097/CORR.0000000000000495.
PubMed 30247228
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Outcomes of Surgical Stabilization and Conservative Treatment in Patients With Isolated Minor Rib Fractures: A Prospective Observational Cohort Study.
- ClinicalTrials.gov ID
- NCT04104932
- Acronym / sponsor ID
- N201903152
- Conditions
- Rib Fractures
- Keywords
- surgical stabilization, conservative treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Taipei Medical University Shuang Ho HospitalUniversity, hospital or other
- Study start
- Jul 2019 (estimated)
- Primary completion
- 14 Jul 2023 (estimated)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 26 Sep 2019 (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 purpose of this research is to compare the outcomes of surgical stabilization and conservative treatment in patients with isolated minor rib fractures.
Detailed description
Isolated minor rib fractures (IMRFs), which is defined by single or two isolated minor rib fractures caused by trauma or stress. Traditionally, rib fractures are managed mainly by surgical stabilization or conservative treatment. In 2018, a systemic review and meta-analysis for patients with multiple rib fractures had revealed a shorter duration of mechanical ventilation, shorter hospital length of stay, and fewer trauma-associated complications in the surgical group than in the non-surgical group. In contrast, IMRFs are seldom life threatening, and compared to extremity fractures, rib fractures do not require matching accurately. Thus, IMRFs are usually treated conservatively. However, the investigators have clinically observed that patients suffering severe pain due to progressive rib displacement may take longer to return to normal activity, have lower quality of life, and even an increased risk of complications. Moreover, limited studies discussed the efficacy of surgical interventions for IMRFs. Therefore, the investigators conduct a prospective observational cohort study to compare the outcomes of surgical stabilization and conservative treatment in patients with IMRFs. The investigators collect patients with IMRFs whose situation were both suitable for surgical and non-surgical interventions. After explanation, patients can decide to undergo conservative or surgical treatment by themselves. The investigators will follow up pain scores, chest X-ray, pulmonary function tests, and duration of return to normal activity. Those data will be statistically analyzed by two-tailed two-sample t-test. This prospective cohort study is supposed to provide more evidence for clinical decision making and optimal management of IMRFs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical group | – | Procedure: Open reduction and internal fixationPatients with isolated minor rib fractures received surgical stabilization. |
| Conservative group | – | –Patients with isolated minor rib fractures received conservative treatment, such as NSAIDs. |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with isolated minor rib fractures
Key inclusion criteria (3 listed)
- Patient age ≥ 20 years old.
- Patient was diagnosed with isolated minor rib fractures by thoracic surgeon.
- Patient was suitable for both surgical stabilization and conservative treatment.
Key exclusion criteria (3 listed)
- Severe trauma associated to other systems.
- Pathologic fractures: such as fracture due to metastasis or steroid therapy.
- Unconsciousness or disturbed conscious level.
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 |
|---|---|---|
| Open reduction and internal fixationOpen reduction and internal fixation | Procedure or surgery | Surgical group |
Primary outcome
Duration of return to normal activity
Time frame: 3 months after operation or after injury
From day of injury to day of return to normal activity
Pain score change at 1 week
Time frame: Change from injury or operation at 1 week
Pain Visual analog scales (Pain VAS) to measure pain intensity. A 10 cm horizontal line will be shown and patients mark on the line representing their perception of their current state. The score range from 0 to 10, with following cutpoints: no pain (0 cm), mild pain(1-4 cm), moderate pain (5-7 cm), and severe pain (8-10 cm).
Pain score change at 3 months
Time frame: Change from injury or operation at 3 months
Pain Visual analog scales (Pain VAS) to measure pain intensity. A 10 cm horizontal line will be shown and patients mark on the line representing their perception of their current state. The score range from 0 to 10, with following cutpoints: no pain (0 cm), mild pain(1-4 cm), moderate pain (5-7 cm), and severe pain (8-10 cm).
5 secondary outcomes
Forced vital capacity (FVC) change
Time frame: Change from injury or operation at 3 months
Forced expiratory volume in the first second (FEV1) change
Time frame: Change from injury or operation at 3 months
Total lung capacity (TLC) change
Time frame: Change from injury or operation at 3 months
Peak expiratory flow (PEF) change
Time frame: Change from injury or operation at 3 months
36-Item Short Form Survey (SF-36) results
Time frame: At 3 months after injury or operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
- Background: PubMed 30247228Liang YS, Yu KC, Wong CS, Kao Y, Tiong TY, Tam KW. Does Surgery Reduce the Risk of Complications Among Patients with Multiple Rib Fractures? A Meta-analysis. Clin Orthop Relat Res. 2019 Jan;477(1):193-205. doi: 10.1097/CORR.0000000000000495.
- Individual participant dataSharing planned: Yes. as required
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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.
Tung-Yu Tiong, MD principal investigator
Taipei Medical University Shuang Ho Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Rib Fractures, run by Taipei Medical University Shuang Ho Hospital.
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 3 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: status not confirmed, as of the sponsor's last update on 26 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tung-Yu Tiong, MD (+886970747235, dr_tiong@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of return to normal activity (time frame: 3 months after operation or after injury). The study lists 3 primary outcomes in all. 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 NCT04104932, 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 26 Sep 2019.