Clinical Trials Directory

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UnknownNCT04104932

Surgical and Conservative Treatment in Isolated Minor Rib Fractures

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

Status
Unknown
Phase
Study type
Observational
Enrollment
120 (estimated)
Sponsor
Taipei Medical University Shuang Ho Hospital · Academic / Other
Sex
All
Age
20 Years – 100 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREOpen reduction and internal fixationOpen reduction and internal fixation

Timeline

Start date
2019-07-01
Primary completion
2023-07-14
Completion
2023-10-30
First posted
2019-09-26
Last updated
2019-09-26

Source: ClinicalTrials.gov record NCT04104932. Inclusion in this directory is not an endorsement.