Rib Fracture MultipleNCT05758870
A Prospective Randomized Controlled Study Comparing the Clinical Effects of Surgical and Non-surgical Treatment of Low Rib Fractures
An observational study of Rib Fracture Multiple, run by Shanghai Jiao Tong University Affiliated Sixth People's Hospital.
Trial summary
The purpose of this study is to explore the difference between the clinical effects of surgical and non-surgical treatment for patients with low rib fracture, and to explore whether SSRF has more clinical treatment advantages in patients with low rib fracture in a randomized, controlled and prospective manner. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rib Fracture Multiple
- What is being tested?
- surgical stabilization of low rib fratures and converstive treatment of low rib fratures
- Type of treatment
- Surgery or procedure
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2023to 31 Dec 2025
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patient with multiple rib fractures combines with low rib fractures
Who may be able to join
- Patients with chest trauma only and unilateral low rib fractures Three rib fractures and more Displacement of the broken end of the fracture (bicortical fracture and not in the same line) Time from injury to hospital < 24 hours Age 18-70 ASA grade I-II Preoperative arterial oxygen partial pressure >60mmHg, carbon dioxide partial pressure <50mmHg The participate is volunteer in the study and sign the informed consent Pain score( Number Rating Scale, NRS) >5 under calm breathing
Who cannot join
- Difficult airway History of esophageal reflux Myasthenia gravis Coagulation disorders Gastrointestinal ulcer Gastrointestinal bleeding Anesthetic drugs allergy history Asthma Chronic obstructive pulmonary disease Pregnant women
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
The purpose of this study is to explore the difference between the clinical effects of surgical and non-surgical treatment for patients with low rib fracture, and to explore whether SSRF has more clinical treatment advantages in patients with low rib fracture in a randomized, controlled and prospective manner.
- Conditions
- Rib Fracture Multiple
- Being tested
- surgical stabilization of low rib fratures, converstive treatment of low rib fratures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical stabilization of low rib fraturesProcedure or surgery
surgical stabiliazation of rib fractures by internal fixation
converstive treatment of low rib fraturesOther
chest wall fixation band
| Study group | Role | What they receive |
|---|---|---|
| Research Group | surgical stabilization of low rib fracures by internal fixation Receives: Procedure: surgical stabilization of low rib fratures | |
| Controls Group | conservative treatment of low rib fractures Receives: Other: converstive treatment of low rib fratures |
What is being measured
The primary outcome is the main question the study is designed to answer.
EQ-5D-5L
appraisal of life quality
Measured: On the day of admission
EQ-5D-5L
appraisal of life quality
Measured: 1 week after treatment
EQ-5D-5L
appraisal of life quality
Measured: 2 weeks after treatment
EQ-5D-5L
appraisal of life quality
Measured: 1 month after treatment
EQ-5D-5L
appraisal of life quality
Measured: 3 months after treatment
EQ-5D-5L
appraisal of life quality
Measured: 6 months after treatment
Secondary outcomes (6)
Pain Score
Number Rating Score, NRS
Measured: On the day of admission
Pain Score
Number Rating Score, NRS
Measured: 1 week after treatment
Pain Score
Number Rating Score, NRS
Measured: 2 weeks after treanment
Pain Score
Number Rating Score, NRS
Measured: 1 month after treatment
Pain Score
Number Rating Score, NRS
Measured: 3 months after treatment
Pain Score
Number Rating Score, NRS
Measured: 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start1 Apr 2023 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rib Fracture MultipleStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University Affiliated Sixth People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wu Weiming, Shanghai Jiao Tong University Affiliated Sixth People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05758870
- Sponsor's protocol ID
- 20220815
- Status last verified
- Feb 2023
- First submitted
- 11 Feb 2023
- Last updated
- 8 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
- ClinicalTrials.gov ID
- NCT05758870
- Acronym / sponsor ID
- 20220815
- Conditions
- Rib Fracture Multiple
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University Affiliated Sixth People's HospitalUniversity, hospital or other
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 8 Mar 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 purpose of this study is to explore the difference between the clinical effects of surgical and non-surgical treatment for patients with low rib fracture, and to explore whether SSRF has more clinical treatment advantages in patients with low rib fracture in a randomized, controlled and prospective manner.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Research Group | – | Procedure: surgical stabilization of low rib fraturessurgical stabilization of low rib fracures by internal fixation |
| Controls Group | – | Other: converstive treatment of low rib fraturesconservative treatment of low rib fractures |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient with multiple rib fractures combines with low rib fractures
Key inclusion criteria (1 listed)
- Patients with chest trauma only and unilateral low rib fractures Three rib fractures and more Displacement of the broken end of the fracture (bicortical fracture and not in the same line) Time from injury to hospital < 24 hours Age 18-70 ASA grade I-II Preoperative arterial oxygen partial pressure >60mmHg, carbon dioxide partial pressure <50mmHg The participate is volunteer in the study and sign the informed consent Pain score( Number Rating Scale, NRS) >5 under calm breathing
Key exclusion criteria (1 listed)
- Difficult airway History of esophageal reflux Myasthenia gravis Coagulation disorders Gastrointestinal ulcer Gastrointestinal bleeding Anesthetic drugs allergy history Asthma Chronic obstructive pulmonary disease Pregnant women
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 |
|---|---|---|
| surgical stabilization of low rib fraturessurgical stabiliazation of rib fractures by internal fixation | Procedure or surgery | Research Group |
| converstive treatment of low rib fratureschest wall fixation band | Other | Controls Group |
Primary outcome
EQ-5D-5L
Time frame: On the day of admission
appraisal of life quality
EQ-5D-5L
Time frame: 1 week after treatment
appraisal of life quality
EQ-5D-5L
Time frame: 2 weeks after treatment
appraisal of life quality
EQ-5D-5L
Time frame: 1 month after treatment
appraisal of life quality
EQ-5D-5L
Time frame: 3 months after treatment
appraisal of life quality
EQ-5D-5L
Time frame: 6 months after treatment
appraisal of life quality
6 secondary outcomes
Pain Score
Time frame: On the day of admission
Pain Score
Time frame: 1 week after treatment
Pain Score
Time frame: 2 weeks after treanment
Pain Score
Time frame: 1 month after treatment
Pain Score
Time frame: 3 months after treatment
Pain Score
Time frame: 6 months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Rib Fracture Multiple, run by Shanghai Jiao Tong University Affiliated Sixth People's 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 1 inclusion and 1 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 8 Mar 2023. 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 Weiming Wu (18930172451, wuweiming0427@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EQ-5D-5L (time frame: On the day of admission). The study lists 6 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 8 Mar 2023.