Dual Implant Versus Single Implant Distal End of Femur

Enrolling by invitation · Not applicable

Conditions studied: Distal Femur Fracture

In brief

The investigators overall study objective is to determine the difference in outcomes for patients over 60 years of age with a displaced distal femur fracture treated with dual distal femur implants (dual plate or IMN/plate) vs. a single distal femur implant (plate or IMN).

Key facts

Study ID

NCT05292313

Run by

University of Utah

People needed

80

Starts

2022-03-14

Expected to finish

2027-02-01

Last updated by the study team

2026-04-13

Who can join

Age: 60 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient age 60 years or greater,
• 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,
• Displaced fracture (>2.5mm displacement, native or periprosthetic)

You may not qualify if…

• Associated major lower extremity fracture,
• Ongoing infection,
• History of metabolic bone disease (Paget's, etc),
• Pathologic fracture,
• Gustilo-Anderson Type 3B/3C open fractures,
• 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,
• Bilateral femur fractures,
• Unable to follow-up at treating institution for 12 months

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States
• New York University — New York, New York, United States
• Oregon Health & Science Center — Portland, Oregon, United States
• University of Pittsburg Medical Center - Harrisburg — Harrisburg, Pennsylvania, United States
• University of Utah Orthopaedic Center — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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