The University of Southern California has been approved for $10.8 million in research funding by the Patient-Centered Outcomes Research Institute (PCORI) to compare approaches to treating older adults with a fracture of the hip. Led by principal investigator Joseph Patterson, MD, an orthopedic surgeon specializing in fracture care at Keck Medicine of USC, the "FASTER-Hip" trial aims to determine whether patients with a certain type of hip fracture fare better with a hip replacement or a simpler surgery known as internal fixation.
The trial leadership team includes co-principal investigators Gerard Slobogean, MD, director of clinical research for the Department of Orthopaedics at University of Maryland School of Medicine, and Sheila Sprague, PhD, research director in the Department of Surgery at McMaster University in Ontario, Canada.
Each year, more than 5 million older adults around the world suffer hip fractures, which can be debilitating and sometimes fatal. One common type of hip fracture, a femoral neck fracture, involves the neck of the femur bone in the upper thigh. One in five femoral neck fractures is minimally displaced, meaning the bone is broken but the pieces remain in close contact or are only slightly separated.
For decades, surgeons have mainly used internal fixation to repair these minimally displaced fractures. This easier, shorter procedure uses metal screws and plates to stabilize the bone while it heals. Compared to hip replacement, internal fixation is less invasive and carriers a lower risk of certain complications, such as dislocation and infection. But new data indicate that the procedure is no panacea: 14% of patients who receive internal fixation eventually need another operation, such as a hip replacement.
"If we go directly to hip replacement in these cases, that's a bigger operation. It takes more time, there's more blood loss, and the complications are different," said Patterson, who is also director of orthopaedic trauma research in the Department of Orthopaedic Surgery and assistant professor at the Keck School of Medicine of USC. "Surgeons have strong feelings about these two procedures. We want to know what the evidence shows. Is starting with the larger surgery better for these patients?"
Patterson and his team at USC will administer the clinical trial, which will enroll 600 patients, ages 60 and older, from 32 clinical sites across the United States, Canada and Europe. Sprague will oversee the trial's methods center and infrastructure. Slobogean will oversee protocol and patient engagement aspects of the trial.
A focus on patients
Most clinical trials in orthopaedic surgery focus on outcomes that matter to surgeons, insurers and health care systems. These include whether patients survive, get readmitted to the hospital or require additional surgery.
Where this trial differs: We have assembled and will continue to work with a core group of patient stakeholders, as well as everyone who touches the patient throughout their recovery."
Joseph Patterson, MD, orthopedic surgeon, Keck Medicine of USC
He and his team have recruited patients, family members, geriatricians, rehabilitation professionals (such as physical and occupational therapists), and representatives from insurance companies and professional societies. The group will convene several times per year throughout the trial to ensure researchers are collecting data that patients care about.
The patient-focused approach is central to PCORI, an independent, nonprofit organization with a mission to fund patient-centered comparative clinical effectiveness research (CER). CER provides patients, their caregivers and clinicians with the evidence-based information they need to make better-informed health and health care decisions.
"Already, our engagement with patients and their caregivers has revealed outcomes that matter to them, outcomes which differ from the ones we tend to think about as surgeons and epidemiologists," Patterson said.
In addition to survival and avoiding additional surgeries, patients value going home, living independently, and regaining the ability to walk.
Guiding medical practice
The findings of the comparative effectiveness research study could inform clinical guidelines, which are recommendations that help clinicians, patients and their caregivers make decisions about care.
Most societies reevaluate clinical evidence every one to two years and adjust their guidelines as needed. Several leading groups-including the Orthopaedic Trauma Association, the American Academy of Orthopaedic Surgeons, and the American Association of Hip and Knee Surgeons-have already expressed support for the trial.
Findings from the research can help patients and their providers make the choice that is right for them. For example, some patients place a high priority on living independently, while others may prefer to avoid a second surgery.
"Our goal is to generate the evidence that surgeons around the world can use to have conversations with patients and their family members about how best to achieve their goals," Patterson said.
This award has been approved pending completion of PCORI's business and programmatic review and issuance of a formal award contract.
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