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Evaluation of the Change in Length of the Leg in Children After Treatment of Femur Fractures.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00355420
Recruitment Status : Withdrawn
First Posted : July 21, 2006
Last Update Posted : March 4, 2014
Sponsor:
Information provided by:
Hadassah Medical Organization

Tracking Information
First Submitted Date July 20, 2006
First Posted Date July 21, 2006
Last Update Posted Date March 4, 2014
Study Start Date October 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of the Change in Length of the Leg in Children After Treatment of Femur Fractures.
Official Title Evaluation of the Change in Length of the Femur and Tibia in Children After Treatment of Femur Fractures With External Fixators, Plaster of Paris or Internal Fixation
Brief Summary Femur fractures are a common injury in the Pediatric population. Despite their high incidence little do we know about the long term implications on the bones' length. Our main goal is to clarify this obscure issue by assessing the femoral and tibial length as determined by the fractures, measuring techniques and treatment modalities
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population children that sufferinf from LLD
Condition Fractures
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: March¬†3,¬†2014)
0
Original Enrollment Not Provided
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility Criteria

Inclusion Criteria:

  • Males between the ages 0-16.
  • Females between the ages 0-14.
  • Signed Informed consent

Exclusion Criteria:

  • A refusal by the patient or his legal guardian to continue the follow-up with the
  • Pediatric Orthopedic clinic, or to have the CT scanograms.
  • Patients with severe contractures in the lower extremities
  • Patients with multiple lower extremity fractures
  • Pregnancy
Sex/Gender
Sexes Eligible for Study: All
Ages up to 16 Years   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT00355420
Other Study ID Numbers LLD01-HMO-CTIL
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor Hadassah Medical Organization
Collaborators Not Provided
Investigators
Principal Investigator: Ron Lamdan, Dr. Hadassah Medical Organization
Study Chair: Shlomo Porat, Prof. Hadassah Medical Organization
Study Director: Naum Simanovski, Dr. Hadassah Medical Organization
PRS Account Hadassah Medical Organization
Verification Date March 2013