Surgical and Conservative Treatment in Isolated Minor Rib Fractures

NCT ID: NCT04104932

Last Updated: 2019-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-31

Study Completion Date

2023-10-30

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.

Conditions

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Rib Fractures

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Surgical group

Patients with isolated minor rib fractures received surgical stabilization.

Open reduction and internal fixation

Intervention Type PROCEDURE

Open reduction and internal fixation

Conservative group

Patients with isolated minor rib fractures received conservative treatment, such as NSAIDs.

No interventions assigned to this group

Interventions

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Open reduction and internal fixation

Open reduction and internal fixation

Intervention Type PROCEDURE

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Medical University Shuang Ho Hospital

OTHER

Sponsor Role lead

Responsible Party

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Tung-Yu, Tiong

Attending surgeon of thoracic surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tung-Yu Tiong, MD

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University Shuang Ho Hospital

Central Contacts

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Tung-Yu Tiong, MD

Role: CONTACT

+886970747235

References

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Liang YS, Yu KC, Wong CS, Kao Y, Tiong TY, Tam KW. Does Surgery Reduce the Risk of Complications Among Patients with Multiple Rib Fractures? A Meta-analysis. Clin Orthop Relat Res. 2019 Jan;477(1):193-205. doi: 10.1097/CORR.0000000000000495.

Reference Type BACKGROUND
PMID: 30247228 (View on PubMed)

Other Identifiers

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N201903152

Identifier Type: -

Identifier Source: org_study_id

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