Dislocated Clavicular Fracture Treated With Elastic Stable Intramedullary NailingESIN clavicleNCT01325129
Elastic Stable Intramedullary Nailing of Dislocated Clavicle Fractures in Children
An observational study of Dislocated Clavicular Fracture Treated With Elastic Stable Intramedullary Nailing, run by University of Luebeck at 1 site in Germany.
Trial summary
Most Clavicular Fractures in Children can be Treated Conservatively. Our Own Study showed a Benefit towards Much Lower Pain and Better Cosmesis in Adolescents when Treated with Elastic Stable Intramedullary Nailing. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Dislocated Clavicular Fracture Treated With Elastic Stable Intramedullary Nailing
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2011to Dec 2012
- 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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Last 24 Patients we Treated with ESIN
Who may be able to join
- Only Dislocated Shaft Fractures or Pseudarthrosis after Conservative Treatment of Dislocated CSF in Children and Adolescents Treated with Elastic Stable Intramedullary Nailing
Who cannot join
- Age > 17 years
- Pathologic fractures
- Lateral or Medial Fractures of the Clavicle
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Pediatric Surgery University Hospital
Lübeck, 23538
About this study
Official title: Elastic Stable Intramedullary Nailing of Dislocated Clavicle Fractures in Children and Adolescents: Lessons Learned From the First 20 Patients
Most Clavicular Fractures in Children can be Treated Conservatively. Our Own Study showed a Benefit towards Much Lower Pain and Better Cosmesis in Adolescents when Treated with Elastic Stable Intramedullary Nailing.
The First 20 Patients Treated with this Method will be examined for Functional (CONSTANT and MURLEY-Score) and Cosmetic Results as well as Ultrasound-Morphology of both clavicles and Patients'satisfaction (CSS-8). Further on, all complications and problems will be documented.
- Keywords
- ESIN, Clavicular Fracture, Dislocation, Children, Adolescents
- Medical subject headings
- Joint Dislocations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2011 (estimated)
- Study startApr 2011
- Primary completionMar 2012
- Study completionDec 2012
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 Dislocated Clavicular Fracture Treated With Elastic Stable Intramedullary NailingStudies 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
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Luebeck
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin M Kaiser, University of Luebeck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01325129
- Sponsor's protocol ID
- DE814167313
- Acronym
- ESIN clavicle
- Status last verified
- Feb 2014
- First submitted
- 28 Mar 2011
- Last updated
- 14 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Prinz KS, Rapp M, Kraus R, Wessel LM, Kaiser MM. [Dislocated midclavicular fractures in children and adolescents: who benefits from operative treatment?]. Z Orthop Unfall. 2010 Jan;148(1):60-5. doi: 10.1055/s-0029-1186155. Epub 2009 Oct 19. German.
PubMed 20135591Rapp M, Prinz K, Kaiser MM. Elastic stable intramedullary nailing for displaced pediatric clavicle midshaft fractures: a prospective study of the results and patient satisfaction in 24 children and adolescents aged 10 to 15 years. J Pediatr Orthop. 2013 Sep;33(6):608-13. doi: 10.1097/BPO.0b013e31829d1a76.
PubMed 23812152
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elastic Stable Intramedullary Nailing of Dislocated Clavicle Fractures in Children and Adolescents: Lessons Learned From the First 20 Patients
- ClinicalTrials.gov ID
- NCT01325129
- Acronym / sponsor ID
- ESIN clavicle / DE814167313
- Keywords
- ESIN, Clavicular Fracture, Dislocation, Children, Adolescents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of LuebeckUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 29 Mar 2011 (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.
Most Clavicular Fractures in Children can be Treated Conservatively. Our Own Study showed a Benefit towards Much Lower Pain and Better Cosmesis in Adolescents when Treated with Elastic Stable Intramedullary Nailing.
The First 20 Patients Treated with this Method will be examined for Functional (CONSTANT and MURLEY-Score) and Cosmetic Results as well as Ultrasound-Morphology of both clavicles and Patients'satisfaction (CSS-8). Further on, all complications and problems will be documented.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Last 24 Patients we Treated with ESIN
Key inclusion criteria (1 listed)
- Only Dislocated Shaft Fractures or Pseudarthrosis after Conservative Treatment of Dislocated CSF in Children and Adolescents Treated with Elastic Stable Intramedullary Nailing
Key exclusion criteria (3 listed)
- Age > 17 years
- Pathologic fractures
- Lateral or Medial Fractures of the Clavicle
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 14 Feb 2014.
- Background: PubMed 20135591Prinz KS, Rapp M, Kraus R, Wessel LM, Kaiser MM. [Dislocated midclavicular fractures in children and adolescents: who benefits from operative treatment?]. Z Orthop Unfall. 2010 Jan;148(1):60-5. doi: 10.1055/s-0029-1186155. Epub 2009 Oct 19. German.
- Results publication: PubMed 23812152Rapp M, Prinz K, Kaiser MM. Elastic stable intramedullary nailing for displaced pediatric clavicle midshaft fractures: a prospective study of the results and patient satisfaction in 24 children and adolescents aged 10 to 15 years. J Pediatr Orthop. 2013 Sep;33(6):608-13. doi: 10.1097/BPO.0b013e31829d1a76.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Dislocated Clavicular Fracture Treated With Elastic Stable Intramedullary Nailing, run by University of Luebeck at 1 site in Germany.
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 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 Feb 2014. 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 Germany. 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?
On the ClinicalTrials.gov record for NCT01325129, 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 Feb 2014.