- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04104932
Surgical and Conservative Treatment in Isolated Minor Rib Fractures
September 24, 2019 updated by: Tung-Yu, Tiong, Taipei Medical University Shuang Ho Hospital
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
120
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Tung-Yu Tiong, MD
- Phone Number: +886970747235
- Email: dr_tiong@yahoo.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 100 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with isolated minor rib fractures
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Severe trauma associated to other systems.
- Pathologic fractures: such as fracture due to metastasis or steroid therapy.
- Unconsciousness or disturbed conscious level.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Surgical group
Patients with isolated minor rib fractures received surgical stabilization.
|
Open reduction and internal fixation
|
Conservative group
Patients with isolated minor rib fractures received conservative treatment, such as NSAIDs.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
3 months after operation or after injury
|
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).
|
Change from injury or operation at 1 week
|
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).
|
Change from injury or operation at 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Forced vital capacity (FVC) change
Time Frame: Change from injury or operation at 3 months
|
Pulmonary function testing with spirometry, using percent of the predicted value (%)
|
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
|
Pulmonary function testing with spirometry, using percent of the predicted value (%)
|
Change from injury or operation at 3 months
|
Total lung capacity (TLC) change
Time Frame: Change from injury or operation at 3 months
|
Pulmonary function testing with spirometry, using percent of the predicted value (%)
|
Change from injury or operation at 3 months
|
Peak expiratory flow (PEF) change
Time Frame: Change from injury or operation at 3 months
|
Pulmonary function testing with spirometry, in unit of liters per minute
|
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
|
Quality of life will be evaluated via SF-36 questionnaire, and will be scored according to SF-36 scoring rules
|
At 3 months after injury or operation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Tung-Yu Tiong, MD, Taipei Medical University Shuang Ho Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
July 1, 2019
Primary Completion (ANTICIPATED)
July 14, 2023
Study Completion (ANTICIPATED)
October 30, 2023
Study Registration Dates
First Submitted
June 28, 2019
First Submitted That Met QC Criteria
September 24, 2019
First Posted (ACTUAL)
September 26, 2019
Study Record Updates
Last Update Posted (ACTUAL)
September 26, 2019
Last Update Submitted That Met QC Criteria
September 24, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- N201903152
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
as required
IPD Sharing Time Frame
as required
IPD Sharing Access Criteria
as required
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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