Trauma Clinical Trial
Official title:
A Multicentre Observational Case-controlled Feasibility Study: In Children Who Ride Bikes or Scooters, is the Risk of Sustaining a Serious Injury Greater When Metal Handlebar Ends Are Exposed Than When They Are Covered by Intact Grips?
Cycling injuries are the 3rd most common mechanism of injury in 7-13 year olds[1]. Bicycle
injuries have remained one of the commonest causes of paediatric abdominal trauma for over
60 years[2,3]. 15% of child cyclist injuries involve impact with a handlebar; two-thirds of
those are abdominal injuries[4]. Handlebar impact is now the commonest mechanism of major
paediatric abdominal injury[3]. Serious handlebar injuries often occur after apparently
minor falls; they are not unique to riders performing stunts[5].
One small study found that the metal handlebar ends were often exposed on bikes of children
sustaining severe abdominal injuries[6]. Most European safety standards do not test grip
durability[7-10]. Day-to-day use can damage rubber grips, exposing the underlying metal
handlebar tube.
This feasibility study aims to test the research methods that will be used in a subsequent
nationwide multicentre study. The main study will investigate the association between
injuries and handlebar grip condition.
Children attending study hospitals with any bicycle or kick scooter injury will be invited
to participate. Parents of injured children will be invited to complete questionnaires
regarding circumstances surrounding the injury and condition of the handlebar ends on the
bike or scooter involved. Clinical information regarding the injury will also be collected.
The handlebar end condition will be compared between children sustaining a handlebar end
injury [Cases] and riders whose injury did not involve the handlebar [Controls].
If exposed handlebar ends are more prevalent amongst riders with handlebar end injuries,
injury prevention strategies can focus on methods to prevent damage occurring to grips
through day-to-day use. If no such association is found, prevention strategies can be
focused elsewhere, such as on design of effective protective clothing.
Data collection for this feasibility study will occur between March 2015 and September 2015.
The Chief Investigator, Mr. Andrew Neilson, funds the feasibility study.
Injuries are the most common cause of death of children aged 1-14 years in the European
Union[11]. In the United States cyclist injuries are the 3rd most common mechanism of injury
in 7-13 year olds, after motor vehicle collisions (MVC) and falls[1]. Bicycle injuries have
remained one of the most common causes of paediatric abdominal trauma for over 60
years[2,3]. The vast majority (95-98%) of child cyclists admitted due to abdominal trauma
are over 5 years old[2,3]. As with most mechanisms of injury, boys are injured more
frequently than girls. Around three quarters of injured child cyclists are boys[12].
In a recent UK study, handlebar end impact was the mechanism that most frequently resulted
in major intra-abdominal trauma in children. Impact with a handlebar end was implicated in
29% of cases. This was ahead of falls (20%), pedestrians (8%) and MVC occupants (8%)[3]. A
study conducted in Australia found 15% of child cyclist injuries involved impact with a
handlebar, and 10% of all child cyclist injuries were abdominal handlebar injuries[4]. A
study in Philadelphia found that 8% of all paediatric bicycle-related trauma admissions
involved handlebars impacting the abdomen resulting in an injury with an Abbreviated Injury
Scale (AIS) score of 2 or greater[13].
The majority of handlebar injury case series reported in the literature relate to children's
abdominal injuries. The peak incidence occurs between 6 and 14 years of age[4]. However,
adults can also sustain serious handlebar related injuries[14-16] and 36% of all handlebar
injured patients sustain only extra-abdominal injuries[4]. It is not just pedal cyclists who
are at risk of these injuries. Incidents also involve non-motorized kick scooters,
moto-cross bikes, motorbikes and quad bikes[3,4].
Crash investigations have found that serious handlebar injuries often occur after apparently
minor incidents; they are not unique to riders performing stunts or those riding BMX
bikes[5,6]. There is a typical sequence of events common to many of these handlebar
injuries[5]. The child loses control of the bike and begins to fall. The front wheel rotates
through 90 degrees so that it is perpendicular to the child's body. The child continues to
fall forwards, landing on the upturned handlebar end.
Children's bikes and scooters often have damaged rubber grips with exposed metal handlebar
ends. This occurs through day-to-day use. Each time the child drops their bike or scooter on
its side, the handlebar end contacts the ground. When it does so, the metal tube inside the
rubber grip cuts into that rubber. With time, a circle is cut from the rubber end, exposing
the metal pipe within.
Handlebar end injuries can occur both when the handlebar ends are exposed and when they are
intact. Two studies from the 1990s have looked at the condition of the handlebar end
implicated in such injuries[5,6].
Acton et al published a series of 21 patients who reported handlebar impact as the cause of
their injuries. Re-interview found that metal handlebar ends were exposed on bikes of all 10
children who sustained a major abdominal injury, whilst exposed handlebar ends were present
on only one bike of 8 respondents with minor abdominal injuries[6].
Winston et al included detailed analysis on 4 riders who sustained serious abdominal
injuries due to landing on a handlebar end. They found that these serious injuries occurred
in 3 riders despite the presence of protective rubber covering on the handlebar ends. The
rider who impacted an exposed metal handlebar end, however, had a particularly serious
injury. He was a 6-year-old boy who sustained a life threatening liver laceration[5].
Identifying if there is an association between the condition of handlebar grips and the
likelihood of sustaining an injury is the ultimate aim of the main GRIP study. This
feasibility study aims to test the intended methodology prior to rolling out a nationwide
multicentre study. The feasibility study will allow power calculations to be performed for
the nationwide study. The primary outcome of the nationwide study will address whether
children falling onto exposed metal handlebar ends are at a greater risk of sustaining an
injury than those who fall onto handlebars with intact rubber grips. A sub-study will
explore whether there is any relationship between injury severity and grip condition.
Our clinical experience tells us that serious handlebar injuries do occur even when
handlebar grips are intact. The investigators also know through anecdotes that some riders
fall onto their handlebar ends and never attend hospital because no injury or only a minor
injury is sustained. The cases presenting to tertiary paediatric units represent the 'tip of
the iceberg'. A study to accurately identify the number of children who fall onto a
handlebar but do not present to hospital is unlikely to be feasible. This is why the
investigators have designed a case-controlled study.
If the nationwide multicentre GRIP study rejects the null hypothesis, then the investigators
can focus on passive injury prevention strategies relating to handlebar ends. There are two
aspects that could easily be addressed by safety standards. Grip durability and grip end
minimum diameter. Improved durability should reduce the number of bikes or scooters in
circulation with exposed metal handlebar ends. Larger diameter ends distribute any end-on
impact over a larger surface area and hence reduce the pressure exerted on the point of
contact.
Currently only one of the many applicable European safety standards includes a drop test of
handlebar grip durability[9]. This standard for BMX bikes was introduced in 2012. However,
the drop test has not been included in the more recently published standard for Bicycles for
Young Children[10].
A minimum grip diameter requirement has been included in the standard for Bicycles for Young
Children. It specifies that handlebars shall be fitted with handlebar grips, and that such
grips shall be of resilient material and shall have an enlarged and covered end not less
than 40mm in diameter[10]. That standard applies only to bikes suitable for children up to
around 5 years of age. There is no such minimum handlebar end diameter requirement applied
to bicycles ridden by children over 5 years of age, or to kick scooters. These standards
simply require the handlebar to be fitted with handgrips or end plugs[7-9].
If, however, the nationwide multicentre GRIP study accepts the null hypothesis, the
investigators can focus handlebar-related injury prevention on more complex mechanical
solutions such as steering limiters or compressible handlebar ends, and on design of
effective protective clothing. Some of the secondary outcomes the investigators propose
addressing will be useful if it is found that exposed handlebar ends are not a risk factor
for this injury mechanism.
;
Observational Model: Case Control, Time Perspective: Prospective
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04848376 -
Post-Market Clinical Follow-up Study of A-SPINE's Products
|
||
Terminated |
NCT03781817 -
Intranasal Versus Intravenous Ketamine for Procedural Sedation in Children With Non-operative Fractures
|
Phase 4 | |
Completed |
NCT04342416 -
Using a Brief Visuospatial Interference Intervention to Reduce Intrusive Memories Among Trauma Exposed Women
|
N/A | |
Recruiting |
NCT04856449 -
DBT Skills Plus EMDR for BPD and Trauma
|
N/A | |
Completed |
NCT04356963 -
Adjunct VR Pain Management in Acute Brain Injury
|
N/A | |
Completed |
NCT05669313 -
The Effects of Hypothermia and Acidosis on Coagulation During Treatment With Rivaroxaban Measured With ROTEM
|
||
Active, not recruiting |
NCT03622632 -
Pilot Study to Measure Uric Acid in Traumatized Patients: Determinants and Prognostic Association
|
||
Recruiting |
NCT04725721 -
Testing FIRST in Youth Outpatient Psychotherapy
|
N/A | |
Active, not recruiting |
NCT05530642 -
An Augmented Training Program for Preventing Post-Traumatic Stress Injuries Among Diverse Public Safety Personnel
|
N/A | |
Not yet recruiting |
NCT05649891 -
Checklists Resuscitation Emergency Department
|
N/A | |
Not yet recruiting |
NCT03696563 -
FreeO2 PreHospital - Automated Oxygen Titration vs Manual Titration According to the BLS-PCS
|
N/A | |
Withdrawn |
NCT03249129 -
Identification of Autoantibodies and Autoantigens in the Cerebrospinal Fluid of Patients With Spinal Cord Trauma
|
||
Completed |
NCT02240732 -
Surgical Tourniquets and Cerebral Emboli
|
N/A | |
Completed |
NCT02227979 -
Effects of PURPLE Cry Intervention
|
N/A | |
Withdrawn |
NCT01169025 -
Fentanyl vs. Low-Dose Ketamine for the Relief of Moderate to Severe Pain in Aeromedical Patients
|
N/A | |
Recruiting |
NCT01812941 -
Evaluation of Mitochondrial Dysfunction in Severe Burn and Trauma Patients
|
N/A | |
Completed |
NCT01475344 -
Fibrinogen Concentrate (FGTW) in Trauma Patients, Presumed to Bleed (FI in TIC)
|
Phase 1/Phase 2 | |
Completed |
NCT03112304 -
Child STEPS for Youth Mental Health in Maine Sustainability
|
N/A | |
Completed |
NCT01201863 -
Neuroendocrine Dysfunction in Traumatic Brain Injury: Effects of Testosterone Therapy
|
Phase 4 | |
Completed |
NCT01210417 -
Trauma Heart to Arm Time
|
N/A |