Standard Reaming Versus Reaming/Irrigating/Aspirating for Intramedullary Nailing of Femoral Shaft Fractures

Study Overview
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Brief Summary
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Reaming (enlarging of the bone canal) is commonly performed prior to the insertion of intramedullary nails for the fixation of long bone fractures. This study is designed to compare the union rates between fractures reamed by standard reaming versus reaming with a Reamer/Irrigator/ Aspirator (RIA). In addition, this study will collect patient-based outcomes on these patients. Little information exists on the patient based outcomes following femur fractures. We hope that the patient based outcomes of this study will also be able to aid physicians in advising patients with femur fractures of their possible outcomes.

Official Title
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Standard Reaming Versus Reaming/Irrigating/Aspirating for Intramedullary Nailing of Femoral Shaft Fractures

Conditions
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Femoral Fractures

Intervention / Treatment
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* Procedure: Standard Reaming
* Procedure: Reaming/Irrigating/Aspirating


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men or women between the ages of 18 years and 85 years; Acute fractures of the femoral shaft Exclusion Criteria: Fractures not amenable to intramedullary nailing and deemed by the treating surgeon; Pathological fractures; Open fractures; Patients with additional injuries to the ipsilateral femur; Surgical delay of greater than 7 days from the time of injury; Retained hardware in the affected limb; Previous infection in fractured limb; Likely problems in the judgment of the investigators with maintaining follow-up; Patients with severe cognitive injuries or disabilities will be excluded if it is deemed that they will be unable to complete the study questionnaires; Hopeless diagnosis; Medical comorbidities that prohibit the conductance of surgical treatment under a general anesthetic; Fractures requiring cephalomedullary nails

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Standard Reaming of femoral shaft fracture prior to intramedullary nailing | Procedure: Standard Reaming<br>* Femoral reaming using standard reaming techniques of multiple reamers<br>|
| Active Comparator: 2<br>Reamer/Irrigator/Aspirating of femoral shaft fracture prior to intramedullary nailing | Procedure: Reaming/Irrigating/Aspirating<br>* Reaming using the Reamer/Irrigator/Aspirating<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fracture Healing |  | 3 months, 6 months, 1 year, 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Based Quality of Life |  | Baseline, 3 months, 6 months, 1 year, 2 years |