Clinical trial NCT04104932: Surgical and Conservative Treatment in Isolated Minor Rib Fractures
Official title: Comparison of the Outcomes of Surgical Stabilization and Conservative Treatment in Patients With Isolated Minor Rib Fractures: A Prospective Observational Cohort Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rib Fractures
Keywords: surgical stabilization
conservative treatment
Lead sponsor: Taipei Medical University Shuang Ho Hospital
Sponsor class: OTHER
First posted: 2019-09-26
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with isolated minor rib fractures

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Duration of return to normal activity
timeFrame: 3 months after operation or after injury
measure: Pain score change at 1 week
timeFrame: Change from injury or operation at 1 week
measure: Pain score change at 3 months
timeFrame: Change from injury or operation at 3 months
Secondary outcomes:
measure: Forced vital capacity (FVC) change
timeFrame: Change from injury or operation at 3 months
measure: Forced expiratory volume in the first second (FEV1) change
timeFrame: Change from injury or operation at 3 months
measure: Total lung capacity (TLC) change
timeFrame: Change from injury or operation at 3 months
measure: Peak expiratory flow (PEF) change
timeFrame: Change from injury or operation at 3 months
measure: 36-Item Short Form Survey (SF-36) results
timeFrame: At 3 months after injury or operation
Other outcomes:
Locations:
Study officials:
affiliation: Taipei Medical University Shuang Ho Hospital
name: Tung-Yu Tiong, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.