Surgical and Conservative Treatment in Isolated Minor Rib Fractures

Rib Fractures Clinical Trial

Official title:

Comparison of the Outcomes of Surgical Stabilization and Conservative Treatment in Patients With Isolated Minor Rib Fractures: A Prospective Observational Cohort Study.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04104932
• Other study ID #: N201903152
• Status: Not yet recruiting
• Start date: July 2019
• Est. completion date: October 30, 2023

Study information

• Verified date: September 2019
• Source: Taipei Medical University Shuang Ho Hospital
• Contact: Tung-Yu Tiong, MD
• Phone: +886970747235
• Email: dr_tiong[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: October 30, 2023
• Est. primary completion date: July 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Rib Fractures

Intervention

Procedure:
• Open reduction and internal fixation
Open reduction and internal fixation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University Shuang Ho Hospital

References & Publications (1)

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. Erratum in: Clin Orthop Relat Res. 2019 Mar;477(3):667. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of return to normal activity	From day of injury to day of return to normal activity	3 months after operation or after injury
Primary	Pain score change 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
Primary	Pain score change 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	Forced vital capacity (FVC) change	Pulmonary function testing with spirometry, using percent of the predicted value (%)	Change from injury or operation at 3 months
Secondary	Forced expiratory volume in the first second (FEV1) change	Pulmonary function testing with spirometry, using percent of the predicted value (%)	Change from injury or operation at 3 months
Secondary	Total lung capacity (TLC) change	Pulmonary function testing with spirometry, using percent of the predicted value (%)	Change from injury or operation at 3 months
Secondary	Peak expiratory flow (PEF) change	Pulmonary function testing with spirometry, in unit of liters per minute	Change from injury or operation at 3 months
Secondary	36-Item Short Form Survey (SF-36) results	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