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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00200135
Other study ID # MMC 04-18
Secondary ID
Status Completed
Phase N/A
First received September 12, 2005
Last updated July 2, 2013
Start date June 2005
Est. completion date September 2009

Study information

Verified date July 2013
Source Memorial Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The purpose of this study is to find out how many helmeted versus non-helmeted motorcycle accident victims (MCA) sustain head and/or face injuries. Also, we will find out how much it costs to get medical care for head and face injuries in helmeted versus non-helmeted motorcycle victims. Finally, we will compare how long it takes helmeted versus non-helmeted motorcycle victims with face and head injuries to return to work.


Description:

This is a prospective, quasi-experimental research study that will compare clinical outcomes of helmeted versus non-helmeted motorcycle victims admitted to trauma centers, as well as victims treated and released from emergency departments.

The primary objective of this study is:

- To determine if the financial charges and ratio of cost to charges (RCC), including acute hospitalization, rehabilitation or skilled care, outpatient care, and time to return to work (implying lost wages) is different between helmeted versus non-helmeted motorcyclists with head or face injuries

Secondary objectives include:

- To determine if inpatient mean total acute care and downstream charges and RCC are higher for non-helmeted versus helmeted motorcycle victims admitted to three Pennsylvania trauma centers with head and face injuries

- To determine the mean time of return to full duty work (at previous level of employment) is shorter for helmeted or non-helmeted motorcycle victims admitted to three Pennsylvania trauma centers with head and face injuries

- To determine if non-helmeted or helmeted motorcycle victims admitted to three Pennsylvania trauma centers have increased incidence and severity of head and face injuries

- To determine the incidence and severity of non-helmeted motorcycle accident victims is higher than helmeted counterparts treated and released from emergency departments for face and head injuries

- To determine if non-helmeted motorcycle victims die at scene or in emergency departments (from head and face injuries) more often than helmeted motorcycle victims

- To determine if more helmeted or non-helmeted motorcycle accident victims require no immediate medical care for head and face injuries


Recruitment information / eligibility

Status Completed
Enrollment 480
Est. completion date September 2009
Est. primary completion date September 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- All English speaking drivers/passengers of motorcycle accidents, 18 years or older, with head or face injuries served by participating study trauma centers, emergency departments or coroners.

- All English speaking drivers/passengers of motorcycle accidents, 18 years of age or older, served by Pennsylvania police but did not require acute medical services.

Exclusion Criteria:

- Non-English speaking

- Served by trauma center, emergency department or coroner, but without haed or face injury

- Less than 18 years of age

- Moped accidents

- Motorized bicycle accidents

- Parked motorcycle accidents

- Off road motorcycle accidents, not on a public street or highway

- Dirtbike or motorcross accidents, involving vehicles not licensed for highway use

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States Geisinger Medical Center Danville Pennsylvania
United States Memorial Medical Center Johnstown Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Memorial Medical Center

Country where clinical trial is conducted

United States, 

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