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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04104932
Enrollment
120
Registered
2019-09-26
Start date
2019-07-31
Completion date
2023-10-30
Last updated
2019-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rib Fractures

Keywords

surgical stabilization, conservative treatment

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.

Interventions

Open reduction and internal fixation

Sponsors

Taipei Medical University Shuang Ho Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 100 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Duration of return to normal activity3 months after operation or after injuryFrom day of injury to day of return to normal activity
Pain score change at 1 weekChange from injury or operation at 1 weekPain 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 monthsChange from injury or operation at 3 monthsPain 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

MeasureTime frameDescription
Peak expiratory flow (PEF) changeChange from injury or operation at 3 monthsPulmonary function testing with spirometry, in unit of liters per minute
Forced vital capacity (FVC) changeChange from injury or operation at 3 monthsPulmonary function testing with spirometry, using percent of the predicted value (%)
36-Item Short Form Survey (SF-36) resultsAt 3 months after injury or operationQuality of life will be evaluated via SF-36 questionnaire, and will be scored according to SF-36 scoring rules
Forced expiratory volume in the first second (FEV1) changeChange from injury or operation at 3 monthsPulmonary function testing with spirometry, using percent of the predicted value (%)
Total lung capacity (TLC) changeChange from injury or operation at 3 monthsPulmonary function testing with spirometry, using percent of the predicted value (%)

Contacts

Primary ContactTung-Yu Tiong, MD
dr_tiong@yahoo.com+886970747235

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026