Femur Fracture
Conditions
Brief summary
This research study is being conducted to examine the effect of two versus one fixation device for fixation of distal femur fractures.
Interventions
PROCEDURESingle Distal Femur Implant
Single implant constructs will be either a retrograde intramedullary nail with interlocking screws or a single plate and screw construct.
PROCEDUREDual Distal Femur Implant
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.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of study-eligible subjects | Baseline | Total number of subjects to be enrolled in the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operative times | Duration of surgery, approximately 2-4 hours | Total recorded amount of time in minutes to complete the surgery |
| Blood loss | Duration of surgery, approximately 2-4 hours | Total amount of surgical blood loss, reported in mL. |
| Hospitalization days | approximately 2-3 days | Total number of days a subject requires hospitalization after surgery |
| Early post-surgical complications | 2 weeks post-surgery | Number of subjects to experience venous thromboembolism (VTE), cardiopulmonary, and/or infectious complications after surgery |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBrandon Yuan, MD
Mayo Clinic
Outcome results
None listed