Dual Implant Versus Single Implant Distal End of Femur

Study Overview
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Brief Summary
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This research study is being conducted to examine the effect of two versus one fixation device for fixation of distal femur fractures.

Official Title
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Pilot for Dual Implant Versus Single Implant Distal End of Femur (pDISIDE Femur)

Conditions
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Femur Fracture

Intervention / Treatment
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* Procedure: Single Distal Femur Implant
* Procedure: Dual Distal Femur Implant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Femur fracture distal to the femoral diaphysis. Operative treatment within 72 hours of presenting to the treating hospital. Patient was previously ambulatory. Fracture amendable to either single or dual implant fixation. Informed consent can be obtained from the patient, family member, or power of attorney. Exclusion Criteria: Associated major lower extremity fracture. Ongoing infection. History of metabolic bone disease (Paget's, etc). Pathologic fracture. Open fracture. Severe cognitive impairment (Six Item Screener with 3 or more errors). Stage 5 Parkinson's disease. Significant femoral bone loss requiring planned staged bone grafting. Vascular injury.

Ages Eligible for Study
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Minimum 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Single Distal Femur Implant Group<br>Subjects will receive one of two types of implants for the distal femur fracture. The single implant will be either a plate and screws or a rod. The type of single implant used will be determined by the surgeon based on the characteristics of the fracture. | Procedure: Single Distal Femur Implant<br>* Single implant constructs will be either a retrograde intramedullary nail with interlocking screws or a single plate and screw construct.<br>|
| Experimental: Dual Distal Femur Implant Group<br>Subjects will receive two implants for fixation of the distal femur fracture. The dual implant will be either 2 plates with screws or a plate with screws and a rod. The type of dual implant used will be determined by the surgeon based on the characteristics of the fracture. | Procedure: Dual Distal Femur Implant<br>* Dual implant constructs will either be an intramedullary nail with an additional plate and screw construct or dual (two plates in any orientation) plate and screw construct.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of study-eligible subjects | Total number of subjects to be enrolled in the study | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative times | Total recorded amount of time in minutes to complete the surgery | Duration of surgery, approximately 2-4 hours | 
| Blood loss | Total amount of surgical blood loss, reported in mL. | Duration of surgery, approximately 2-4 hours | 
| Hospitalization days | Total number of days a subject requires hospitalization after surgery | approximately 2-3 days | 
| Early post-surgical complications | Number of subjects to experience venous thromboembolism (VTE), cardiopulmonary, and/or infectious complications after surgery | 2 weeks post-surgery |