NCT03487458

Brief Summary

This study is a prospective study. Patients with traumatic rib fractures are divided into control group and surgical (OP) group, depending on whether they undergo rib fracture fixation surgeries. They complete Short Form-36 and Work Quality Index (WQI) before surgery and after surgery (before discharge, post-surgery 1 month, 3 months and 6 months). The goal of this study is to examine the life quality of patients who receive surgical treatment for rib fracture by analyzing patients' response, comorbidity, vital signs (blood pressure, heart rate, respiratory rate, Glasgow Coma Scale (GCS) etc.), severity of fracture (AIS, ISS) and medical costs. The investigators hope to find the most suitable method of treatment for patients with rib fractures.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 13, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 5, 2017

Completed
5 months until next milestone

First Posted

Study publicly available on registry

April 4, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2018

Completed
Last Updated

April 4, 2018

Status Verified

June 1, 2017

Enrollment Period

12 months

First QC Date

November 5, 2017

Last Update Submit

April 3, 2018

Conditions

Rib Fractures

Outcome Measures

Primary Outcomes (1)

  • Short Form-36 (SF-36)

    questionnaire filled by patient

    Assessment of change in SF-36 scores for the control group at admission and after discharge for up to six months and for the surgical group before and after surgery for up to 6 months.

Secondary Outcomes (4)

  • Work Quality Index (WQI)

    Assessment of change in WQI for the control group at admission and after discharge for up to six months and for the surgical group before and after surgery through study completion for up to 6 months.

  • Days of admission

    Assessment of total number of days of hospitalization including ICU stay after admission through study completion for up to 6 months.

  • Severity of hemothorax

    Assessment of progression or resolution of hemothorax after simple chest drainage for up to 3 days after chest drainage insertion in the control group and before operation, post-OP day 1, and post-OP day 3 for up to 3 days' post-operation in the surgical

  • Pain

    Every 8 hours during hospitalization for up to 1 month and outpatient follow-up at 1 month, 3 months and 6 months after discharge through study completion for a total of 6 months.

Study Arms (2)

Control

NO INTERVENTION

participants receive no surgical treatment

Rib Fixation Surgery

EXPERIMENTAL

participants receive surgical treatment

Procedure: Rib Fixation Surgery

Interventions

Rib Fixation SurgeryPROCEDURE

Rib Fixation Surgery

Rib Fixation Surgery

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Absolute Indications:
  • Flail chest with paradoxical respiration
  • Multiple rib fractures with uncontrolled hemothorax or pneumothorax
  • Severe thoracic trauma causing respiratory failure (ex poor blood oxygen saturation, hypercapnia, overtime intubation etc.)
  • Relative Indications:
  • Fractures of 3 or more ribs, with moderate amount of hemothorax or pneumothorax
  • Fractures of 3 or more ribs, with clavicle or scapula fractures, requiring surgical intervention
  • Fractures of 3 or more ribs, with obvious rib displacement and pain
  • Chronic neuropathic pain, with poor drug control
  • Symptoms due to poor healing of fracture site (ex. dyspnea or restrictive lung disease)
  • Chest deformity or other cosmetic factors
  • Other personal factors (ex. disability caused by rib fractures)

You may not qualify if:

  • High risk for surgery (ex. Age greater than 75 y/o, poor cardiopulmonary function, abnormal coagulation, end-stage renal disease, hepatic failure etc.)
  • Severe chest trauma, with large area of lung contusion or pulmonary embolism
  • More than 2 organs of systemic severe trauma (ex. combining head trauma, abdominal internal bleeding, abdominal organ rupture etc.)
  • Poor rib fracture site (ex. posterior axillary line, 1st-3rd rib, sub-scapula etc.)
  • Patient refuses surgery
  • current acute infection
  • Allergy to surgical instruments
  • Lack of sufficient blood supply, poor bone density or potential infection
  • Psychiatric or neuropathic conditions causing inability to obey doctor's order

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 10048, Taiwan

RECRUITING

MeSH Terms

Conditions

Rib Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesThoracic Injuries

Central Study Contacts

Hsien-Chi Liao

CONTACT

886-2-23123456polarisliao@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2017

First Posted

April 4, 2018

Study Start

June 13, 2017

Primary Completion

June 12, 2018

Study Completion

June 12, 2018

Last Updated

April 4, 2018

Record last verified: 2017-06

Locations

TW(1)