Text Size

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
  Purpose

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.


Condition
Dislocated Clavicular Fracture Treated With Elastic Stable Intramedullary Nailing

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Elastic Stable Intramedullary Nailing of Dislocated Clavicle Fractures in Children and Adolescents: Lessons Learned From the First 20 Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Luebeck:

Enrollment: 20
Study Start Date: April 2011
Estimated Study Completion Date: December 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Last 20 Patients we Treated with ESIN

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01325129

Locations
Germany
Department of Pediatric Surgery University Hospital
Luebeck, Germany, 23538
Sponsors and Collaborators
University of Luebeck
  More Information

Publications:

Responsible Party: Martin M Kaiser, Consultant, University of Luebeck
ClinicalTrials.gov Identifier: NCT01325129     History of Changes
Other Study ID Numbers: DE814167313
Study First Received: March 28, 2011
Last Updated: August 12, 2012
Health Authority: Germany: University Luebeck Hospital, Luebeck

Keywords provided by University of Luebeck:
ESIN
Clavicular Fracture
Dislocation
Children
Adolescents

Additional relevant MeSH terms:
Fractures, Bone
Dislocations
Wounds and Injuries

ClinicalTrials.gov processed this record on May 16, 2013