Craniocerebral TraumaNCT00200135
Financial and Clinical Impact of Repeal of the Pennsylvania Motorcycle Helmet Law
An observational study of Craniocerebral Trauma and Facial Injuries, run by Memorial Medical Center at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Craniocerebral Trauma, Facial Injuries
- How many people
- 480 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2005to Sep 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 60 helmeted and 60 unhelmeted motorcycle riders in each cohort
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Geisinger Medical Center
Danville, Pennsylvania, 17822
Memorial Medical Center
Johnstown, Pennsylvania, 15905
About this study
Official title: Financial and Clinical Impact of Repeal of the Pennsylvania Helmet Law: A Multi-Center Prospective Study Comparing Helmeted and Non-Helmeted Motorcycle Accident Victims
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.
Read the detailed 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
- Conditions
- Craniocerebral Trauma, Facial Injuries
- Keywords
- motorcycle accident, helmet, traumatic brain injury, financial burden
- Medical subject headings
- Craniocerebral Trauma, Facial Injuries, Brain Injuries, Traumatic, Financial Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJun 2005
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Craniocerebral TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Stephen L Miller, MD, FACS, Principal investigator, Memorial Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00200135
- Sponsor's protocol ID
- MMC 04-18
- Status last verified
- Jul 2013
- First submitted
- 12 Sep 2005
- Last updated
- 3 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Financial and Clinical Impact of Repeal of the Pennsylvania Helmet Law: A Multi-Center Prospective Study Comparing Helmeted and Non-Helmeted Motorcycle Accident Victims
- ClinicalTrials.gov ID
- NCT00200135
- Acronym / sponsor ID
- MMC 04-18
- Conditions
- Craniocerebral Trauma, Facial Injuries
- Keywords
- motorcycle accident, helmet, traumatic brain injury, financial burden
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Memorial Medical CenterUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 60 helmeted and 60 unhelmeted motorcycle riders in each cohort
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2013.
Related trials for Craniocerebral Trauma
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
Not yet recruitingPhase 1
Nanopulse Laser Therapy
TBI (Traumatic Brain Injury)
RecruitingObservational study
Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence
Chronic Subdural Hematoma
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen L Miller, MD, FACS principal investigator
Memorial Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Craniocerebral Trauma and Facial Injuries, run by Memorial Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2013.