Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
60 participants
INTERVENTIONAL
2024-04-29
2026-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Single Distal Femur Implant Group
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.
Single Distal Femur Implant
Single implant constructs will be either a retrograde intramedullary nail with interlocking screws or a single plate and screw construct.
Dual Distal Femur Implant Group
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.
Dual 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.
Interventions
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Single Distal Femur Implant
Single implant constructs will be either a retrograde intramedullary nail with interlocking screws or a single plate and screw construct.
Dual 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
60 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Brandon James Yuan
Principal Investigator
Principal Investigators
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Brandon Yuan, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic Minnesota
Rochester, Minnesota, United States
Countries
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Other Identifiers
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22-004415
Identifier Type: -
Identifier Source: org_study_id
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