Titanium Elastic Nails in the Treatment of Pediatric Femur Fractures

Femur Fracture Clinical Trial

Official title:

Titanium Elastic Nails in the Treatment of Paediatric Femoral Fractures: A Prospective Randomized Clinical Trial of Eliminating Nail Protrusion to Decrease Soft Tissue Complications

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00175656
• Other study ID #: H03-70522
• Secondary ID: W03-0165
• Status: Completed
• Phase: Phase 1
• First received: September 13, 2005
• Last updated: April 12, 2011
• Start date: January 2007
• Est. completion date: January 2008

Study information

• Verified date: April 2011
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 15 Years

Eligibility

Inclusion Criteria:

open femoral physes; closed midshaft femur fracture; no concomitant injuries to either lower extremity; no history of injury to either femur; no history of asymmetric femoral malalignment; agree to participate in 2 years of follow up; informed consent/assent.

Exclusion Criteria:

open midshaft femur fractures; other injuries to either lower extremity; a history of injury to either femur; unable to comply with 2 years of follow-up

Study Design

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

Related Conditions & MeSH terms

• Femoral Fractures
• Femur Fracture
• Fractures, Bone

Intervention

Procedure:
• Elimination of titanium elastic nail prominence at the insertion site and leaving the nails in situ
See Detailed Description.

Locations

Country	Name	City	State
Canada	BC Children's Hospital, Department of Orthopaedics	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To investigate the soft tissue complication rate and to determine the clinical and functional outcomes at 4 months following femoral fracture reduction using titanium elastic nails in skeletally immature patients.		4 months	No
Secondary	To compare the clinical and functional outcomes between leaving the nails in situ and removing them; 1 year and 2 year follow-up.		1 and 2 years	No