Dual Implant Versus Single Implant Distal End of Femur
Not Applicable
Recruiting
- Conditions
- Femur Fracture
- Registration Number
- NCT06032299
- Lead Sponsor
- Mayo Clinic
- Brief Summary
This research study is being conducted to examine the effect of two versus one fixation device for fixation of distal femur fractures.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Number of study-eligible subjects Baseline Total number of subjects to be enrolled in the study
- Secondary Outcome Measures
Name Time Method Early post-surgical complications 2 weeks post-surgery Number of subjects to experience venous thromboembolism (VTE), cardiopulmonary, and/or infectious complications after surgery
Hospitalization days approximately 2-3 days Total number of days a subject requires hospitalization after surgery
Blood loss Duration of surgery, approximately 2-4 hours Total amount of surgical blood loss, reported in mL.
Operative times Duration of surgery, approximately 2-4 hours Total recorded amount of time in minutes to complete the surgery
Trial Locations
- Locations (1)
Mayo Clinic Minnesota
🇺🇸Rochester, Minnesota, United States
Mayo Clinic Minnesota🇺🇸Rochester, Minnesota, United States