Femur Fracture Clinical Trial
Official title:
Pilot for Dual Implant Versus Single Implant Distal End of Femur (pDISIDE Femur)
Verified date | June 2024 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This research study is being conducted to examine the effect of two versus one fixation device for fixation of distal femur fractures.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | September 2025 |
Est. primary completion date | September 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic Minnesota | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of study-eligible subjects | Total number of subjects to be enrolled in the study | Baseline | |
Secondary | Operative times | Total recorded amount of time in minutes to complete the surgery | Duration of surgery, approximately 2-4 hours | |
Secondary | Blood loss | Total amount of surgical blood loss, reported in mL. | Duration of surgery, approximately 2-4 hours | |
Secondary | Hospitalization days | Total number of days a subject requires hospitalization after surgery | approximately 2-3 days | |
Secondary | Early post-surgical complications | Number of subjects to experience venous thromboembolism (VTE), cardiopulmonary, and/or infectious complications after surgery | 2 weeks post-surgery |
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