Titanium Elastic Nails in the Treatment of Pediatric Femur Fractures

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

Detailed Description
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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.

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

Conditions
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Femur Fracture

Intervention / Treatment
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* Procedure: Elimination of titanium elastic nail prominence at the insertion site and leaving the nails in situ


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Elimination of titanium elastic nail prominence at the insertion site and leaving the nails in situ|See Detailed Description.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Femur fracture, titanium elastic nails