Dual Implant Versus Single Implant Distal End of Femur

N/AActive Not RecruitingNCT06032299

Mayo Clinic60 enrolled

Overview

This research study is being conducted to examine the effect of two versus one fixation device for fixation of distal femur fractures.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Femur Fracture

Interventions

Single Distal Femur ImplantPROCEDURE

Single implant constructs will be either a retrograde intramedullary nail with interlocking screws or a single plate and screw construct.

Dual Distal Femur ImplantPROCEDURE

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

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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.

Locations (1)

Mayo Clinic Minnesota

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Number of study-eligible subjects

Total number of subjects to be enrolled in the study

Time frame: Baseline

Secondary Outcomes

Operative times

Total recorded amount of time in minutes to complete the surgery

Time frame: Duration of surgery, approximately 2-4 hours

Blood loss

Total amount of surgical blood loss, reported in mL.

Time frame: Duration of surgery, approximately 2-4 hours

Hospitalization days

Total number of days a subject requires hospitalization after surgery

Time frame: approximately 2-3 days

Early post-surgical complications

Number of subjects to experience venous thromboembolism (VTE), cardiopulmonary, and/or infectious complications after surgery

Time frame: 2 weeks post-surgery

Data from ClinicalTrials.gov

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