New clinical trial aims to improve outcomes for older adults with hip fractures

New clinical trial aims to improve outcomes for older adults with hip fractures

Hip fractures in older adults can lead to serious complications, disability and even death. Traditionally, orthopedic surgeons have repaired a common fracture of the upper part of the thighbone or femur near the hip using screws and plates to slightly separate pieces of bone together. Many surgeons now treat these “minimally displaced” femoral neck fractures by replacing the hip joint with a metal implant.

A new $10.8 million multicenter clinical trial led by Gerard Slobogean, MD, MPH, associate professor of orthopedics and director of clinical research in the department of orthopedics at the University of Maryland School of Medicine (UMSOM), will determine whether hip replacement surgery, also called hip arthroplasty malpractice, generates respect for hip arthroplasty. decades.

Our goal is to improve patient outcomes after often debilitating hip fractures, particularly in older adults. Hip fractures are an important public health problem, and we expect that the results of this study will definitely influence clinical practice regardless of the outcome. “

Dr. Gerard Slobogean, orthopedic trauma surgeon, R Adams Cowley Shock Trauma Center, University of Maryland Medical Center (UMMC)

Each year, more than 5 million older adults around the world receive hip fractures. Femoral neck fractures are very common, and one in five of these fractures are considered minimally displaced, with a small gap between the edges of the broken bone. About 14 percent of those who receive internal fixation surgery ultimately require further surgery, such as: B. a hip replacement.

"We want to answer the question, 'If an older adult has this type of broken hip, does the fracture best replace the hip reduce their ability to walk, increase their time at home and improve their overall health?' " said Dr. Slobogean. "Currently, we have limited clinical research to help patients, caregivers and orthopedic surgeons choose the best treatment for each patient."

Researchers expect to open the randomized controlled clinical trial in the fall. They plan to enroll 600 patients age 60 or older requiring surgery to treat minimally displaced neck fractures at 32 tertiary care and hospitals in the United States, Canada, United Kingdom, Spain, the Netherlands and Norway. The R Adams Cowley Shock Trauma Center - the highest level trauma center - will be one of the locations. Patients will be randomly assigned to receive either internal fixation or hip replacement surgery, and researchers will follow them for 12 months.

The “faster trial” is funded by a $10.8 million Patient-Centered Outcomes Research Institute (PCORI) grant awarded to the University of Southern California (USC). UMSOM researchers will receive $2.5 million from this funding. PCORI is an independent nonprofit organization that funds comparative clinical effectiveness research to help patients and clinicians make better-informed healthcare decisions.

Joseph Patterson, MD, an orthopedic surgeon specializing in fracture care, director of orthopedic trauma research in the Department of Orthopedic Surgery and assistant professor at the Keck School of Medicine in USC, is the principal investigator. Dr. Slobogean and Sheila Sprague, PhD, director of research in the Department of Surgery at McMaster University in Ontario, Canada, are co-principal investigators.

"Hip fractures in older adults are a significant public health problem, with up to 30 percent of people dying in the first year and other traumatic loss of function and ability to lead productive lives," 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 the University of Maryland Medical Affairs. “Evidence from head-to-head clinical trials will help surgeons inform patients whether to choose an immediate hip replacement, which is more time-consuming and involves more blood loss, or an internal fixation procedure, which may require further surgery later.”

UMSOM researchers were instrumental in developing the clinical trial with the help of a National Institutes of Health (NIH) R34 planning grant (R34Ar082550) to Dr. Slobogean. This will be the first clinical trial designed as a Musculoskeletal Adaptive Platform Trial (MAPT), using a Center for Orthopedic Injury Research and Innovation model with NIH funding (R34ar084718). Slobogean.

A platform trial is a type of clinical trial that allows multiple treatments to be tested simultaneously within a single trial design - an approach that reduces costs, speeds up the evaluation process, and improves decision-making when evaluating therapies.

The study was designed and is being conducted with input from orthopedic trauma patients, caregivers and families, orthopedic surgeons, physical therapists, doctors of geriatric medicine, nurses and other health care providers, as well as professional organizations, a peer support network, and a large Medicare benefit plan.

UMSOM orthopedic researchers have significant experience in developing and leading large multicenter international trials. Those from Dr. Slobogean and O'Hara found that skin antisepsis with iodine -Povacrylex in alcohol reduced the risk of surgical site infection for routine orthopedic fracture surgery. Similarly, the Prevention Study led by Robert V. O’Toole, MD, the Hansjörg Wyss Medical Foundation Professor in Orthopedic Trauma at UMSSOM and Chief of Orthopedics in Orthopedic Trauma.

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