NCT00200135

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
480

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2005

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

July 3, 2013

Status Verified

July 1, 2013

Enrollment Period

4.3 years

First QC Date

September 12, 2005

Last Update Submit

July 2, 2013

Conditions

Keywords

motorcycle accidenthelmettraumatic brain injuryfinancial burden

Study Arms (4)

1

Treated and released from ED (minor injuries)

2

Trauma, admitted to the hospital (injured)

3

Fatalities reported by the coroner (deaths)

4

Reported by the police (No medical treatment)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

60 helmeted and 60 unhelmeted motorcycle riders in each cohort

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Memorial Medical Center

Johnstown, Pennsylvania, 15905, United States

Location

MeSH Terms

Conditions

Craniocerebral TraumaFacial InjuriesBrain Injuries, TraumaticFinancial Stress

Condition Hierarchy (Ancestors)

Trauma, Nervous SystemNervous System DiseasesWounds and InjuriesBrain InjuriesBrain DiseasesCentral Nervous System DiseasesStress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Stephen L Miller, MD, FACS

    Memorial Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

June 1, 2005

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

July 3, 2013

Record last verified: 2013-07

Locations