A new $10.8 million multicenter clinical trial co-led by Gerard Slobogean, MD, MPH, an associate professor of orthopaedics and director of clinical research in the department of orthopaedics at the University of Maryland School of Medicine (UMSOM), will determine if hip arthroplasty produces better outcomes for patients age 60 and older who have sustained femoral neck fractures compared to simpler “internal fixation,” which has been performed for decades. Their goal is to improve patient outcomes.
“We want to answer the question, ‘When an older adult has this type of broken hip, does fixing the fracture or replacing the hip best reduce death, maintain their ability to walk, increase their time at home and improve their overall health?’” Slobogean said. “Currently, we have limited clinical research to help patients, caregivers and orthopaedic surgeons choose the best treatment for each patient.”
The randomized controlled clinical trial is set to begin in the fall. They plan to enroll 600 patients age 60 or older who need surgery for minimally displaced femoral neck fractures, at 32 tertiary care and community hospitals in the United States, Canada, the United Kingdom, Spain, the Netherlands, and Norway. Patients will be randomly selected to receive either internal fixation or hip replacement surgery and investigators will follow them for 12 months.
“Evidence from head-to-head clinical trials will help surgeons advise patients on whether to choose an immediate hip replacement, which is more time-consuming and involves more blood loss, or an internal fixation procedure that may require another surgery later,” said Mark T. Gladwin, MD, the John Z. and Akiko K. Bowers distinguished professor and dean of UMSOM, and vice president for medical affairs at University of Maryland, Baltimore.
