IMN Diameter to Femoral Canal Diameter and Union

Study Overview
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Brief Summary
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To Detect the Relation Between the Intramedullary Nail Diameter to Canal Ratio and the Incidence of Non-union

Detailed Description
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Femoral intramedullary nail fixation is currently considered the ''gold standard'' for treatment of femoral shaft fractures in adult population. Clinical outcomes after operative treatment of proximal femur fracture have been shown to be dependent on achieving optimal mechanical alignment and union. Patient independent risk factors associated with nonunion after intramedullary fixation includes: open fracture, undreamed intramedullary nailing, fracture comminution, non-isthmal and particularly infra-isthma fracture location and infection. Patient dependent risk factors include smoking, diabetes, nonsteroidal anti-inflammatory medications, closed head injury and delayed weight. Unreamed nailing allows for better maintenance of the endosteal circulation at the expense of smaller diameter implants; in contrast, reamed applications permit a larger diameter nail, resulting in stronger fixation constructs and earlier fracture union. After reaming, a larger diameter intramedullary nail is placed. When initially reported, this treatment resulted in high success rates.

Official Title
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Does Intramedullary Nail Diameter to Canal Ratio Predict the Incidence of Femoral Nonunion?

Conditions
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Femoral Shaft Fracture

Intervention / Treatment
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* Device: internal fixation by IMN


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age (20_60) years old Closed fracture and open grade one Midshaft fractures type3\2 according to the OA classification pattern of the fracture (simple transverse,oblique ,spiral) Retrograde and Antigrade nail Exclusion Criteria: Open fractures grade two and three. patient with comorbidities eg(DM.HTN…) severe osteoporosis with wide medulla . patient on regular steroid therapy. patient refused to be enrolled in the study

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IMN and union<br>putting an intramedullary nail in femoral shaft fractures and finding a relation between the nail diameter to femoral canal diameter and how this will affect healing or predict union | Device: internal fixation by IMN<br>* using retrograde or antegrade IMN for femooral fractures fixation using a fit nail to the femoral intramedullary canaland follow up for union<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The ratio between IMN and femoral canal diameter and incidence of union objectively | We will measure union objectively using x ray (union in 3 or more cortices) | 6 months | 
| measurement of union clinically | we will measure the union clinically using visual analog score after 6 weeks.( Change From Baseline in Pain Scores on the Visual Analog Scale at 6 Weeks). then we will test if there is a relation between union and the ratio between femoral canal and IMN diameter. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intramedullary nail