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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Distal Femur Implant Group | Active Comparator | 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. |
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| Dual Distal Femur Implant Group | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single Distal Femur Implant | Procedure | Single implant constructs will be either a retrograde intramedullary nail with interlocking screws or a single plate and screw construct. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of study-eligible subjects | Total number of subjects to be enrolled in the study | Baseline |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brandon Yuan, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Minnesota | Rochester | Minnesota | 55905 | United States |
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| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |
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| Dual Distal Femur Implant | Procedure | 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. |
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| 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 |