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

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

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

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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