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, orthopaedic surgeons have repaired a common fracture of the upper part of the thigh bone, or femur, near the hip using screws and plates to piece together slightly separated pieces of bone. But 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 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 replacement surgery, also known as hip arthroplasty, produces better outcomes for patients ages 60 and older than simpler “internal fixation” that has been performed for decades.

Our goal is to improve patient outcomes after often debilitating hip fractures, especially among older adults. Hip fractures are a major public health concern, and we anticipate that the results of this trial will definitively inform clinical practice, regardless of the result.”

Dr. Gerard Slobogean, orthopaedic 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 sustain hip fractures. Femoral neck fractures are very common, and one in five of those 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 need to have another surgery, such as a hip replacement.

“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?'” Dr. Slobogean said. “Currently, we have limited clinical research to help patients, caregivers and orthopaedic 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 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. The R Adams Cowley Shock Trauma Center – the highest-level trauma center in Maryland – will be one of the sites. Patients will be randomly selected to receive either internal fixation or hip replacement surgery and investigators will follow them for 12 months.

The “FASTER-Hip trial” is funded by a $10.8 million grant from the Patient-Centered Outcomes Research Institute (PCORI) 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 orthopaedic surgeon specializing in fracture care, Director of Orthopaedic Trauma research in the Department of Orthopaedic Surgery and Assistant Professor at the Keck School of Medicine at USC, is the principal investigator. Dr. Slobogean and Sheila Sprague, PhD, Research Director in the Department of Surgery at McMaster University in Ontario, Canada, are co-principal investigators.

“Hip fractures among older adults is a significant public health concern, with up to 30 percent of people dying within the first year and others enduring 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 University of Maryland, Baltimore. “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.”

UMSOM researchers were instrumental in developing the clinical trial with the help of a National Institutes of Health (NIH) R 34 planning grant (R34AR082550) awarded to Dr. Slobogean. This will be the first clinical trial designed as a Musculoskeletal Adaptive Platform Trial (MAPT) utilizing a model developed by the University of Maryland’s Center of Orthopaedic Injury Research and Innovation with NIH funding (R34AR084718), according to Nathan O’Hara, PhD, MHA, an Associate Professor of Orthopaedics at UMSOM who serves as COIRI’s co-director with Dr. Slobogean.

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

The trial was designed and will be conducted with input from orthopaedic trauma patients, caregivers and families, orthopaedic surgeons, physical therapists, geriatric medicine doctors, nurses and other healthcare providers as well as professional organizations, a peer support network and a large Medicare advantage plan.

UMSOM orthopaedic researchers have considerable experience developing and leading large multicenter international trials. The PREP-IT trials, conducted by Drs. Slobogean and O’Hara, found that skin antisepsis with iodine povacrylex in alcohol reduced the risk of surgical site infections for routine orthopaedic fracture surgery. Similarly, the PREVENT CLOT trial led by Robert V. O’Toole, MD, the Hansjörg Wyss Medical Foundation Endowed Professor in Orthopaedic Trauma at UMSOM and Chief of Orthopaedics at the R Adams Cowley Shock Trauma Center, found aspirin as effective as blood thinner injections in preventing life-threatening blood clots in patients hospitalized with bone fractures.