Trampoline FractureNCT04028908
Remodelling After Trampoline Fracture in Children
An observational study of Trampoline Fracture and Tibial Fracture, run by Peter Klimek at 2 sites in Switzerland.
Trial summary
The anterior tilting of the proximal tibia epiphyseal plate is a radiological tool for the diagnosis of suspected trampoline fracture. The tibial fracture leads to a ventral tilting of the tibial Plateau. Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Trampoline Fracture, Tibial Fracture
- What is being tested?
- radiographs in two views of the tibia
- How many people
- 86 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 10 Feb 2016to 31 Jan 2020
- 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 2 to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: Children between 2-5 years of life with the diagnosis of a trampoline fracture in the radiographs of the tibia in two views at the Kantonsspital Aarau, Universitätsspital Bern, Universitätskinderspital Zürich, UKBB Universitätsspital Basel, Kantonalspital Luzern.
Who may be able to join
- trampoline fracture of the proximal lower leg
Who cannot join
- proximal tibial fractures with unclear etiology
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Kantonsspital Aarau
Aarau, 5001
Universitätsspital Bern
Bern, 3010
About this study
The anterior tilting of the proximal tibia epiphyseal plate is a radiological tool for the diagnosis of suspected trampoline fracture. The tibial fracture leads to a ventral tilting of the tibial Plateau. This study is to document the long-term follow-up of the anterior tilt angle and to verify, if there is an uplift of the tibia plateau with correction of the anterior tilt angle to normal values (= remodelling) in order to guarantee optimal treatment of this rare fracture.
- Conditions
- Trampoline Fracture, Tibial Fracture
- Being tested
- radiographs in two views of the tibia
- Keywords
- ventral tilting of the tibial plateau, anterior tilt angle, proximal tibia epiphyseal plate
- Medical subject headings
- Tibial Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiographs in two views of the tibiaDiagnostic test
The anterior tilt angle of the tibia will be measured by two specialized radiologists according to a specific radiological angle measurement tool (PACS Sectra IDS7TM, Linköping, Sweden).
What is being measured
The primary outcome is the main question the study is designed to answer.
anterior tilt angle of the tibia
radiological measurement of the anterior tilt angle of the tibia (degree)
Measured: one year after fracture
Secondary outcomes (1)
difference of anterior tilt angle of the fractured tibia compared with the angle of the healthy tibia
difference of anterior tilt angle of the fractured tibia compared with the angle of the healthy tibia (degree)
Measured: one year after fracture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study start10 Feb 2016
- Primary completion15 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trampoline FractureStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peter Klimek
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council Kantonsspital Aarau, Switzerland
- Responsible party
- Sponsor-investigator, Peter Klimek, Kantonsspital Aarau
- Investigators
- Peter Klimek, Dr. med, Principal investigator, Kantonsspital Aarau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04028908
- Sponsor's protocol ID
- 2015-445; ex15Klimek
- Status last verified
- Mar 2020
- First submitted
- 10 Jul 2019
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remodelling After Trampoline Fracture in Children
- ClinicalTrials.gov ID
- NCT04028908
- Acronym / sponsor ID
- 2015-445; ex15Klimek
- Conditions
- Trampoline Fracture, Tibial Fracture
- Keywords
- ventral tilting of the tibial plateau, anterior tilt angle, proximal tibia epiphyseal plate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Peter KlimekUniversity, hospital or other
- Collaborators
- Medical Research Council Kantonsspital Aarau, Switzerland
- Study start
- 10 Feb 2016 (actual)
- Primary completion
- 15 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 23 Jul 2019 (actual)
- 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 anterior tilting of the proximal tibia epiphyseal plate is a radiological tool for the diagnosis of suspected trampoline fracture. The tibial fracture leads to a ventral tilting of the tibial Plateau. This study is to document the long-term follow-up of the anterior tilt angle and to verify, if there is an uplift of the tibia plateau with correction of the anterior tilt angle to normal values (= remodelling) in order to guarantee optimal treatment of this rare fracture.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children between 2-5 years of life with the diagnosis of a trampoline fracture in the radiographs of the tibia in two views at the Kantonsspital Aarau, Universitätsspital Bern, Universitätskinderspital Zürich, UKBB Universitätsspital Basel, Kantonalspital Luzern.
Key inclusion criteria (1 listed)
- trampoline fracture of the proximal lower leg
Key exclusion criteria (1 listed)
- proximal tibial fractures with unclear etiology
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 |
|---|---|---|
| radiographs in two views of the tibiaThe anterior tilt angle of the tibia will be measured by two specialized radiologists according to a specific radiological angle measurement tool (PACS Sectra IDS7TM, Linköping, Sweden). | Diagnostic test | – |
Primary outcome
anterior tilt angle of the tibia
Time frame: one year after fracture
radiological measurement of the anterior tilt angle of the tibia (degree)
1 secondary outcome
difference of anterior tilt angle of the fractured tibia compared with the angle of the healthy tibia
Time frame: one year after fracture
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 4 Mar 2020.
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.
Peter Klimek, Dr. med principal investigator
Kantonsspital Aarau
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 Trampoline Fracture and Tibial Fracture, run by Peter Klimek at 2 sites 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 1 inclusion and 1 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 4 Mar 2020. 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 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?
anterior tilt angle of the tibia (time frame: one year after fracture). It is what the study was designed to measure, not a finding.
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 4 Mar 2020.