DIFFIR: Geriatric Distal Femur Fixation Versus Replacement - A Randomized Controlled Trial of Acute Open Reduction Internal Fixation (ORIF) Versus Distal Femoral Replacement (DFR)

What this Trial Is About

Researchers are conducting a large clinical trial to compare two surgical treatments for distal femur fractures in geriatric patients aged 65 and older. The study aims to determine which approach provides better function, fewer complications, and reduced costs. The trial is motivated by complications seen in standard surgical fixation, such as non-healing fractures, infections, and long immobilization periods that affect recovery, especially in frail or cognitively impaired patients. Participants will be randomly assigned to one of two groups: one undergoing acute distal femoral replacement, where the damaged bone is replaced with an artificial knee prosthesis allowing immediate walking, and the other receiving surgical fixation using plates and screws to stabilize the fracture. Surgeons will choose specific techniques and implants based on standard care practices. This randomized trial involves multiple centers across North America. During the study, participants will be closely monitored through repeated assessments over up to 24 months. Researchers will measure knee pain and function using the Oxford Knee Score at 3, 6, 9, and 12 months after surgery. Other evaluations include pain scales, quality of life questionnaires, range of knee motion, timed mobility tests, and medication use while hospitalized. This thorough follow-up will help compare recovery, mobility, and complication rates between the two treatments.

DIFFIR - Geriatric Distal Femur Fixation Versus Replacement