Surgical and Conservative Treatment in Isolated Minor Rib Fractures

• Conditions: Rib Fractures
• Interventions: Procedure: Open reduction and internal fixation

• Registration Number: NCT04104932
• Lead Sponsor: Taipei Medical University Shuang Ho Hospital

Brief Summary

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 Timeline

• Study First Submitted: 2019-06-28
• Study Start: 2019-07
• Status Verified: 2019-09
• Study First Submitted QC: 2019-09-24
• Last Update Submitted: 2019-09-24
• Study First Posted: 2019-09-26
• Last Update Posted: 2019-09-26
• Primary Completion: 2023-07-14
• Study Completion: 2023-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Surgical group	Open reduction and internal fixation	Patients with isolated minor rib fractures received surgical stabilization.

Primary Outcome Measures

Name	Time	Method
Duration of return to normal activity	3 months after operation or after injury	From day of injury to day of return to normal activity
Pain score change at 1 week	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	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).

Secondary Outcome Measures

Name	Time	Method
Total lung capacity (TLC) change	Change from injury or operation at 3 months	Pulmonary function testing with spirometry, using percent of the predicted value (%)
Peak expiratory flow (PEF) change	Change from injury or operation at 3 months	Pulmonary function testing with spirometry, in unit of liters per minute
36-Item Short Form Survey (SF-36) results	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
Forced vital capacity (FVC) change	Change from injury or operation at 3 months	Pulmonary function testing with spirometry, using percent of the predicted value (%)
Forced expiratory volume in the first second (FEV1) change	Change from injury or operation at 3 months	Pulmonary function testing with spirometry, using percent of the predicted value (%)