A groundbreaking trial which aims to uncover better treatments for hip fractures in older people has been boosted by almost US$11m in funding.
The University of Southern California has been approved for US$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.
Each year, more than five 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 stabilise 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 indicates that the procedure is no panacea: 14 per cent of patients who receive internal fixation eventually need another operation, such as a hip replacement.
Led by principal investigator Joseph Patterson, an orthopaedic surgeon specialising 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.
Patterson says: “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.
“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.
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,” Patterson says.
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 organisation 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 says.