Surgical and Conservative Treatment in Isolated Minor Rib Fractures

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of the Outcomes of Surgical Stabilization and Conservative Treatment in Patients With Isolated Minor Rib Fractures: A Prospective Observational Cohort Study.

Conditions
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Rib Fractures

Intervention / Treatment
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* Procedure: Open reduction and internal fixation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Surgical group<br>Patients with isolated minor rib fractures received surgical stabilization. | Procedure: Open reduction and internal fixation<br>* Open reduction and internal fixation<br>|
| Conservative group<br>Patients with isolated minor rib fractures received conservative treatment, such as NSAIDs. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of return to normal activity | From day of injury to day of return to normal activity | 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). | 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). | Change from injury or operation at 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced vital capacity (FVC) change | 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 | Pulmonary function testing with spirometry, using percent of the predicted value (%) | Change from injury or operation at 3 months | 
| Total lung capacity (TLC) change | Pulmonary function testing with spirometry, using percent of the predicted value (%) | Change from injury or operation at 3 months | 
| Peak expiratory flow (PEF) change | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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surgical stabilization, conservative treatment