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Surgical and Conservative Treatment in Isolated Minor Rib Fractures

T

Taipei Medical University

Status

Unknown

Conditions

Rib Fractures

Treatments

Procedure: Open reduction and internal fixation

Study type

Observational

Funder types

Other

Identifiers

NCT04104932
N201903152

Details and patient eligibility

About

The purpose of this research is to compare the outcomes of surgical stabilization and conservative treatment in patients with isolated minor rib fractures.

Full 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.

Enrollment

120 estimated patients

Sex

All

Ages

20 to 100 years old

Volunteers

No Healthy Volunteers

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.

Trial design

120 participants in 2 patient groups

Surgical group
Description:
Patients with isolated minor rib fractures received surgical stabilization.
Treatment:
Procedure: Open reduction and internal fixation
Conservative group
Description:
Patients with isolated minor rib fractures received conservative treatment, such as NSAIDs.

Trial contacts and locations

0

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Central trial contact

Tung-Yu Tiong, MD

Data sourced from clinicaltrials.gov

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