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NCT01325129 Clinical Trial

Elastic Stable Intramedullary Nailing of Dislocated Clavicle Fractures in Children

Dislocated Clavicular Fracture Treated With Elastic Stable Intramedullary Nailing Clinical Trial

— ESIN clavicle  

Official title:
Elastic Stable Intramedullary Nailing of Dislocated Clavicle Fractures in Children and Adolescents: Lessons Learned From the First 20 Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01325129
Other study ID # DE814167313
Secondary ID
Status Completed
Phase N/A
First received March 28, 2011
Last updated February 13, 2014
Start date April 2011
Est. completion date December 2012

Study information
Verified date February 2014
Source University of Luebeck
Contact n/a
Is FDA regulated No
Health authority Germany: University Luebeck Hospital, Luebeck
Study type Observational

Clinical 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date December 2012
Est. primary completion date March 2012
Accepts healthy volunteers No
Gender Both
Age group N/A to 17 Years
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

  • Dislocated Clavicular Fracture Treated With Elastic Stable Intramedullary Nailing
  • Fractures, Bone

Locations
Country Name City State
Germany Department of Pediatric Surgery University Hospital Luebeck

Sponsors (1)
Lead Sponsor Collaborator
University of Luebeck

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. — View Citation

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 S — View Citation