Titanium Elastic Nails in the Treatment of Pediatric Femur Fractures

This study has been completed.
Sponsor:
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00175656
First received: September 13, 2005
Last updated: April 12, 2011
Last verified: April 2011
  Purpose

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


Condition Intervention Phase
Femur Fracture
Procedure: Elimination of titanium elastic nail prominence at the insertion site and leaving the nails in situ
Phase 1

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

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • 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. [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare the clinical and functional outcomes between leaving the nails in situ and removing them; 1 year and 2 year follow-up. [ Time Frame: 1 and 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: January 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Elimination of titanium elastic nail prominence at the insertion site and leaving the nails in situ
    See Detailed Description.
Detailed 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.

  Eligibility

Ages Eligible for Study:   4 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00175656

Locations
Canada, British Columbia
BC Children's Hospital, Department of Orthopaedics
Vancouver, British Columbia, Canada, V6H 3V4
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Christopher Reilly, MD University of British Columbia
  More Information

No publications provided

Responsible Party: Dr. Christopher Reilly, University of British Columbia
ClinicalTrials.gov Identifier: NCT00175656     History of Changes
Other Study ID Numbers: H03-70522, W03-0165
Study First Received: September 13, 2005
Last Updated: April 12, 2011
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Femur fracture
titanium elastic nails

Additional relevant MeSH terms:
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Leg Injuries

ClinicalTrials.gov processed this record on July 24, 2014