- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01325129
Elastic Stable Intramedullary Nailing of Dislocated Clavicle Fractures in Children (ESIN clavicle)
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.
Study Overview
Status
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Luebeck, Germany, 23538
- Department of Pediatric Surgery University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- Rapp 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DE814167313
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