Surgical and Conservative Treatment in Isolated Minor Rib Fractures

NCT04104932 | Unknown

• 1 other identifier: N201903152
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rib Fractures

Keywords

surgical stabilization; conservative treatment

Outcome Measures

Primary Outcomes (3)

• Duration of return to normal activity

  From day of injury to day of return to normal activity

  3 months after operation or after injury

• 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

• 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 Outcomes (5)

• Forced vital capacity (FVC) change

  Change from injury or operation at 3 months

• Forced expiratory volume in the first second (FEV1) change

  Change from injury or operation at 3 months

• Total lung capacity (TLC) change

  Change from injury or operation at 3 months

• Peak expiratory flow (PEF) change

  Change from injury or operation at 3 months

• 36-Item Short Form Survey (SF-36) results

  At 3 months after injury or operation

Study Arms (2)

Surgical group

Patients with isolated minor rib fractures received surgical stabilization.

Procedure: Open reduction and internal fixation

Conservative group

Patients with isolated minor rib fractures received conservative treatment, such as NSAIDs.

Interventions

Open reduction and internal fixation PROCEDURE

Open reduction and internal fixation

Surgical group

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with isolated minor rib fractures

You may qualify if:

• 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.

You may not qualify if:

• Severe trauma associated to other systems.
• Pathologic fractures: such as fracture due to metastasis or steroid therapy.
• Unconsciousness or disturbed conscious level.

Sponsors & Collaborators

• Taipei Medical University Shuang Ho Hospital: lead

Related 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.

  PMID: 30247228 BACKGROUND

MeSH Terms

Conditions

Rib Fractures

Interventions

Open Fracture Reduction; Fracture Fixation, Internal

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Thoracic Injuries

Intervention Hierarchy (Ancestors)

Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Officials

• Tung-Yu Tiong, MD

  Taipei Medical University Shuang Ho Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tung-Yu Tiong, MD

CONTACT

+886970747235; dr_tiong@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending surgeon of thoracic surgery

Study Record Dates

• First Submitted: June 28, 2019
• First Posted: September 26, 2019
• Study Start: July 1, 2019
• Primary Completion: July 14, 2023
• Study Completion: October 30, 2023
• Last Updated: September 26, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: as required
• Access Criteria: as required