Titanium Elastic Nails in the Treatment of Pediatric Femur Fractures

Status Completed

Clinical Trial Summary

Titanium elastic nails in the pediatric femoral fractures: A prospective randomized clinical trial of eliminating nail protrusion to decrease soft tissue complications

Clinical Trial Description

This study will be conducted as a prospective cohort study of children and adolescents treated with TEN for a femoral shaft fracture. All children and adolescents presenting to the Emergency department of a participating center with a femur fracture will be approached for inclusion in the study. The primary outcome for this study will be functional recovery, as measured using a pediatric specific generic QOL measurement tool. The clinical outcome measure which will be used will be the performance version of the ASK (ASK-p) which has been previously tested and shown to be valid, reliable, and responsive in children and adolescents with acute and chronic Orthopaedic disorders. The first time point for data collection will be at four months. Clinical data which will be obtained over the course of follow-up will include clinical evaluation of hip and knee range of motion, limb rotation, clinical measurement of limb length, fracture union, and the presence of complications, including the need for nail removal in the group in which it was not planned. The second time point for data collection will be at one year. Again, the ASK-p will be mailed to all subjects in advance to allow completion at the desired time. The return of questionnaires and process for reminder notifications will proceed in a similar fashion to the four month time point. Clinical and radiographic data will be collected in a similar fashion to the four month time point. No subjects will be excluded on the basis of failure to return questionnaires at the one year time point since this represents a secondary outcome. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00175656
Study type	Interventional
Source	University of British Columbia
Contact
Status	Completed
Phase	Phase 1
Start date	January 2007
Completion date	January 2008

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.