Radius FracturesGoalkeeperNCT02840188
Young Goalkeeper's Fracture: Radiographic Findings
An observational study of Radius Fractures, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
The aim of this project is to evaluate retrospectively goalkeeper's fractures in children using the children fracture classification and to evaluate the distal radius tilt angle of the growth plate on plain radiographs of the forearm. Read more about this study
- Who is it for?
- Ages 1 year to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Radius Fractures
- What is being tested?
- Radius tilt angle
- How many people
- 179 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2016to 13 Sep 2017
- 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 1 year to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Distal radius fracture in young goalkeepers (=young goalkeeper's fracture)
Who may be able to join
- Children 1-16 years of age with distal radius fracture and the clinical history: "child catches a ball", between 1/2005 - 7/2016.
- Control group (1-16 years) with normal distal radius and no history to catch a ball and no fracture.
- Evaluation of the normal distal tilt angle of the radius.
Who cannot join
- pathological fractures
- other history of trauma than to catch a ball
- patients older than 16 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Young Goalkeeper's Fracture: Radiographic Findings, Risk Factors and Prevention Measures
The aim of this project is to evaluate retrospectively goalkeeper's fractures in children using the children fracture classification and to evaluate the distal radius tilt angle of the growth plate on plain radiographs of the forearm.
Patients positive for goalkeeper's fracture will prospectively answer a questionnaire concerning risk factors and circumstances during the injury.
Read the detailed description
Distal forearm or radius fractures in young goalkeepers have been named "the young goalkeeper's fracture" in the literature. While catching the soccer ball the child suffers a distal forearm fracture due to axial forces to the immature bone of the child. These goalkeeper's fractures on radiographs may be subtle or difficult to discriminate from normal radiographs.
Retrospective study for the evaluation of radiographs of the forearm from 2005 - 2016 of children with history of catching a ball. Two radiologist are blinded for history, age, name and findings on final reports.
First reading without measurement of distal tilt angle, second reading with measurement of distal tilt angle and after consensus meeting.
Questionnaire: prospectively all patients with goalkeeper's fracture will answer a questionnaire concerning circumstances and risks during the accident.
- Conditions
- Radius Fractures
- Being tested
- Radius tilt angle
- Keywords
- goalkeeper's fracture
- Medical subject headings
- Radius Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radius tilt angleOther
Fracture classification in children. Tilt angle measurement of the distal radius growth plate.
| Study group | Role | What they receive |
|---|---|---|
| Radius tilt angle | Children 0-16 years of age positive for distal forearm fracture and positive history of goalkeeper's fracture (to catch a ball). Receives: Other: Radius tilt angle | |
| Normal control group | Children 0-16 years of age without radius fracture and no history of catching a ball. Receives: Other: Radius tilt angle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tilt angle of distal radius growth plate in goalkeeper's fracture
Dorsal angulation of distal radius growth plate in goalkeeper's fracture
Measured: 2005- 2016
Secondary outcomes (1)
Risk factors for goalkeeper's fracture
Questionnaire for circumstances and risks for goalkeeper's fracture
Measured: 2005-2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study startJul 2016
- Primary completion13 Sep 2017
- Study completion13 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Radius FracturesStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Johannes Heverhagen, MD, Study chair, University Hospital Bern, Inselspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02840188
- Sponsor's protocol ID
- KEK-BE: 2016-00670
- Acronym
- Goalkeeper
- Status last verified
- Sep 2017
- First submitted
- 19 Jul 2016
- Last updated
- 14 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Boyd KT, Brownson P, Hunter JB. Distal radial fractures in young goalkeepers: a case for an appropriately sized soccer ball. Br J Sports Med. 2001 Dec;35(6):409-11. doi: 10.1136/bjsm.35.6.409.
PubMed 11726476Kraus R, Szalay G, Meyer C, Kilian O, Schnettler R. [Distal radius fracture - a goalkeepers' injury in children and adolescents]. Sportverletz Sportschaden. 2007 Dec;21(4):177-9. doi: 10.1055/s-2007-963706. German.
PubMed 18072076
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Young Goalkeeper's Fracture: Radiographic Findings, Risk Factors and Prevention Measures
- ClinicalTrials.gov ID
- NCT02840188
- Acronym / sponsor ID
- Goalkeeper / KEK-BE: 2016-00670
- Conditions
- Radius Fractures
- Keywords
- goalkeeper's fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- 13 Sep 2017 (actual)
- Study completion
- 13 Sep 2017 (actual)
- First posted
- 21 Jul 2016 (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 aim of this project is to evaluate retrospectively goalkeeper's fractures in children using the children fracture classification and to evaluate the distal radius tilt angle of the growth plate on plain radiographs of the forearm.
Patients positive for goalkeeper's fracture will prospectively answer a questionnaire concerning risk factors and circumstances during the injury.
Detailed description
Distal forearm or radius fractures in young goalkeepers have been named "the young goalkeeper's fracture" in the literature. While catching the soccer ball the child suffers a distal forearm fracture due to axial forces to the immature bone of the child. These goalkeeper's fractures on radiographs may be subtle or difficult to discriminate from normal radiographs.
Retrospective study for the evaluation of radiographs of the forearm from 2005 - 2016 of children with history of catching a ball. Two radiologist are blinded for history, age, name and findings on final reports.
First reading without measurement of distal tilt angle, second reading with measurement of distal tilt angle and after consensus meeting.
Questionnaire: prospectively all patients with goalkeeper's fracture will answer a questionnaire concerning circumstances and risks during the accident.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radius tilt angle | – | Other: Radius tilt angleChildren 0-16 years of age positive for distal forearm fracture and positive history of goalkeeper's fracture (to catch a ball). |
| Normal control group | – | Other: Radius tilt angleChildren 0-16 years of age without radius fracture and no history of catching a ball. |
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Distal radius fracture in young goalkeepers (=young goalkeeper's fracture)
Key inclusion criteria (3 listed)
- Children 1-16 years of age with distal radius fracture and the clinical history: "child catches a ball", between 1/2005 - 7/2016.
- Control group (1-16 years) with normal distal radius and no history to catch a ball and no fracture.
- Evaluation of the normal distal tilt angle of the radius.
Key exclusion criteria (3 listed)
- pathological fractures
- other history of trauma than to catch a ball
- patients older than 16 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radius tilt angleFracture classification in children. Tilt angle measurement of the distal radius growth plate. | Other | Normal control group, Radius tilt angle |
Primary outcome
Tilt angle of distal radius growth plate in goalkeeper's fracture
Time frame: 2005- 2016
Dorsal angulation of distal radius growth plate in goalkeeper's fracture
1 secondary outcome
Risk factors for goalkeeper's fracture
Time frame: 2005-2016
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 14 Sep 2017.
- Background: PubMed 11726476Boyd KT, Brownson P, Hunter JB. Distal radial fractures in young goalkeepers: a case for an appropriately sized soccer ball. Br J Sports Med. 2001 Dec;35(6):409-11. doi: 10.1136/bjsm.35.6.409.
- Background: PubMed 18072076Kraus R, Szalay G, Meyer C, Kilian O, Schnettler R. [Distal radius fracture - a goalkeepers' injury in children and adolescents]. Sportverletz Sportschaden. 2007 Dec;21(4):177-9. doi: 10.1055/s-2007-963706. German.
- Individual participant dataSharing planned: No
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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.
Johannes Heverhagen, MD study chair
University Hospital Bern, Inselspital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radius Fractures, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 3 inclusion and 3 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 14 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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.
What does the primary outcome measure?
Tilt angle of distal radius growth plate in goalkeeper's fracture (time frame: 2005- 2016). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02840188, which also lists 2 linked publications.
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 14 Sep 2017.