USC is conducting a $10.8 million study of hip fracture surgery options

USC is conducting a $10.8 million study of hip fracture surgery options

The University of Southern California has been approved for $10.8 million in research funding from the Patient-Centered Outcomes Experts Institute (PCORI) to compare approaches to treating older adults with a hip fracture. Led by Principal Investigator Joseph Patterson, MD, an orthopedic surgeon who specializes in fracture care at Keck Medicine of USC, the "faster" study aims to determine whether patients with a particular type of hip fracture do better with a hip replacement or a simpler surgery known as internal fixation.

The Exemal Leadership team includes co-principal investigators Gerard Slobogean, MD, director of clinical research for the Department of Orthopedics at the University of Maryland School of Medicine, and Sheila Sprague, PhD, research director for the Department of Surgery at McMaster University in Ontario, Canada.

Each year, more than 5 million older adults around the world suffer from hip fractures, which can be debilitating and sometimes fatal. A 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 involves minimal displacement, meaning the bone is broken but the parts remain in close contact or are only slightly separated.

For decades, surgeons have primarily used internal fixation to repair these minimally displaced fractures. This lighter, shorter procedure uses metal screws and plates to stabilize the bone while it heals. Compared to HIP exchange, internal fixation is less invasive and carries a low risk of certain complications such as dislocation and infection. However, new data shows that the procedure is not a panacea: 14% of patients who receive internal fixation eventually require another surgery, such as: B. a hip replacement.

"If we go straight to hip replacement in these cases, it's a major surgery. It takes more time, there's more blood loss and the complications are different," said Patterson, who is also director of orthopedic trauma research in the Department of Orthopedic Surgery and an 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 major surgery better for these patients to start with?"

Patterson and his team at USC will administer the clinical trial, which will enroll 600 patients ages 60 and older at 32 clinical sites in the United States, Canada and Europe. Sprague will oversee the trial's Method Center and infrastructure. Slobogean will oversee protocol and patient engagement aspects of the trial.

A focus on patients

Most clinical trials in orthopedic surgery focus on outcomes that matter to surgeons, insurers and health systems. This includes whether patients survive, are readmitted to the hospital or require additional surgery.

Where this effort is different: We have gathered and will continue to work with a core group of patients' patients, 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 study to ensure researchers are collecting data that cares for patients.

The patient-centered approach is central to PCORI, an independent, nonprofit organization with a mission to fund patient-centered comparative clinical effectiveness (CER) research. CER provides patients, their caregivers and clinicians with the evidence-based information they need to make better-informed health and healthcare decisions.

“We have already seen engagement with patients and their caregivers that are important to them, outcomes that are different from those we consider as surgeons and epidemiologists,” Patterson said.

In addition to surviving and avoiding additional surgeries, patients appreciate going home, living independently, and regaining the ability to walk.

Guidance of medical practice

The results of the comparative effectiveness research study could influence clinical guidelines, which are recommendations that help clinicians, patients and their caregivers make decisions about care.

Most societies evaluate clinical evidence every one to two years and adjust their guidelines as necessary. Several leading groups, including the Orthopedic Trauma Association, the American Academy of Orthopedic Surgeons, and the American Association of Hip and Knee Surgeons, have already expressed support for the lawsuit.

Insights from research can help patients and their providers make the right choice for them. For example, some patients place a high priority on independent living, while others prefer to avoid a second surgery.

“Our goal is to generate the evidence that surgeons around the world can have conversations with patients and their family members about how best to achieve their goals,” said Patterson.

This award was approved pending completion of PCORI's business and programmatic review and issuance of a formal award agreement.

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