Elastic Stable Intramedullary Nailing of Dislocated Clavicle Fractures in Children (ESIN clavicle)

This study is enrolling participants by invitation only.

Sponsor:

Information provided by (Responsible Party):

Martin M Kaiser, University of Luebeck

ClinicalTrials.gov Identifier:

NCT01325129

First received: March 28, 2011

Last updated: August 12, 2012

Last verified: August 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	March 28, 2011
Last Updated Date	August 12, 2012
Start Date ^ICMJE	April 2011
Primary Completion Date	March 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT01325129 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Elastic Stable Intramedullary Nailing of Dislocated Clavicle Fractures in Children
Official Title ^ICMJE	Elastic Stable Intramedullary Nailing of Dislocated Clavicle Fractures in Children and Adolescents: Lessons Learned From the First 20 Patients
Brief 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. 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Retrospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Last 20 Patients we Treated with ESIN
Condition ^ICMJE	Dislocated Clavicular Fracture Treated With Elastic Stable Intramedullary Nailing
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Not Provided
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. Epub 2009 Oct 19. German.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Enrolling by invitation
Enrollment ^ICMJE	20
Estimated Completion Date	December 2012
Primary Completion Date	March 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Only Dislocated Shaft Fractures or Pseudarthrosis after Conservative Treatment of Dislocated CSF in Children and Adolescents Treated with Elastic Stable Intramedullary Nailing Exclusion Criteria: Age > 17 years Pathologic fractures Lateral or Medial Fractures of the Clavicle
Gender	Both
Ages	up to 17 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Germany

Administrative Information
NCT Number ^ICMJE	NCT01325129
Other Study ID Numbers ^ICMJE	DE814167313
Has Data Monitoring Committee	Yes
Responsible Party	Martin M Kaiser, University of Luebeck
Study Sponsor ^ICMJE	University of Luebeck
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Luebeck
Verification Date	August 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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