Acute Open Reduction Internal Fixation Versus Distal Femur Replacement

Summary

This study focuses on individuals who have a distal femur fracture. A distal femur fracture is a condition in which the bone breaks in several pieces above the knee joint, requiring surgery. The purpose of the study is to determine which of two types of treatment for distal femur fracture will result in less pain and best recovery (i.e., walk faster, return to daily activities). One treatment option is called surgical fixation. The surgeon fixes the bone with plates or nails, screws, and cables/wires along the side of the fractured bone to hold it together. The other treatment method is called distal femoral replacement, in which the surgeon replaces the knee joint with an artificial knee prosthesis. While both surgeries have been shown to treat fractures successfully, surgeons do not know which one is best. The goal of the study is to directly compare the two treatments to learn which is better (or if they have the same results). Participants will be randomly assigned to receive either distal femoral replacement or surgical fixation.


Inclusion Criteria

  • Male and female patients
  • 65 years and older
  • Isolated fracture of the distal femur (Classification 33)
  • Fracture is amendable to both treatments
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Study Location(s)

Beverly

More about this Clinical Trial

Full Title

DIFFIR: Geriatric Distal Femur: Fixation versus Replacement A Randomized Controlled Trial of Acute Open Reduction Internal Fixation versus Distal Femur Replacement

Details
Disease Type/Condition

Orthopaedics

Principal Investigator

Moon, Charles

Age Group

Adult

Phase

N/A

IRB Number

STUDY00001339

ClinicalTrials.gov ID

NCT04076735

Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?

Details
Disease Type/Condition

Orthopaedics

Principal Investigator

Moon, Charles

Age Group

Adult

Phase

N/A

IRB Number

DIFFIR

ClinicalTrials.gov ID

NCT04076735

Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?