Full Title

DIFFIR: geriatric DIstal Femur: FIxation versus Replacement. A Randomized Controlled Trial of Acute Open Reduction Internal Fixation (ORIF) versus Distal Femur Replacement (DFR)

Eligibility

Inclusion Criteria:
  • Male or female, aged 65 and older
  • Isolated fracture of the distal femur (Classification 33)
  • Fracture is amendable to both treatments
  • Fracture is acute (within 1 week from time of injury)
  • Patient was ambulatory (with or without walking aids) prior to the injury
  • Independent or moderately frail with score of 3 to 6 on the Clinical Frailty Scale
  • Patient is able to read and understand English, French, or Spanish
  • Patient or substitute decision maker is able to provide written informed consent to participate in the study

Exclusion Criteria:

  • Active or previous infection around the fracture (soft tissue or bone)
  • Open fracture
  • Bilateral femur fractures
  • Major vascular injuries requiring intervention, compartment syndrome and major neurologic injuries
  • Pathological fracture excluding osteoporosis
  • Previous surgical fixation or total knee replacement of the distal femur or proximal tibia
  • Previous surgical fixation or hemi/total replacement of the hip
  • Current or previous extensor mechanism (patellar tendon, quadriceps tendon, or patella fracture) disruption or repair
  • Polytrauma (Injury Severity Score > 15) or any associated major injuries of the lower extremities
  • Previous medical diagnosis of dementia
  • Medical or surgical contra-indication to surgery

Contact

PI
Dr. Michael Biddulph

Description

The proposed study is a prospective, randomized controlled trial, involving multiple centers across North America, to compare distal femur replacement (knee prosthesis) versus surgical fixation as a treatment for geriatric distal femur fracture.

Patients 65 years of age and older, with closed, displaced, comminuted distal femur fracture, who meet the inclusion criteria and agree to participate in the study, will be randomly assigned to receive either acute distal femoral replacement or surgical fixation.

The hypothesis is that patients in the acute distal femoral replacement group will have superior function, range of motion, general health status, reduced pain, and lower complications when compared to patients in the surgical fixation group.

Sample size= 146