over 2 years of follow-up. In addition, while functional outcomes modestly favored total hip arthroplasty, the rates of mortality and serious adverse events were similar between the two treatment groups.
Those are key findings from a randomized, multicenter trial of the two procedures that was carried out in 10 countries.
“The American Academy of Orthopedic Surgeons and National Institute for Health and Care Excellence guidelines recommend total hip arthroplasty in all patients with displaced femoral neck fractures who are able to ambulate independently,” a team of investigators led by Mohit Bhandari, MD, and P.J. Devereaux, MD, both from McMaster University, Hamilton, Ont., wrote in a study published in the New England Journal of Medicine. “Our findings suggest that the advantages of total hip arthroplasty may not be compelling. The limited advantages of total hip arthroplasty, as well as the possible higher risk of complications, may be particularly important in regions of the world where total hip arthroplasty is not easily accessible or is cost prohibitive.”
In the Hip Fracture Evaluation With Alternative of Total Hip Arthroplasty Versus Hemiarthroplasty (HEALTH) trial, the researchers randomly assigned 1,495 patients aged 50 years and older who had a displaced femoral neck fracture to undergo either total hip arthroplasty or hemiarthroplasty. They were eligible for the trial only if they had been able to ambulate without the assistance of another person before the hip fracture occurred. The primary endpoint was any unplanned secondary hip procedure within 24 months after the initial surgery. Secondary endpoints included death, serious adverse events, hip-related complications, health-related quality of life, function, and overall health measures. Assessments included the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score, pain score, stiffness score, and function score; the European Quality of Life–5 Dimensions utility index score and visual analogue scale; the 12-Item Short Form General Health Survey physical and mental component summary scores; and the Timed Up and Go scores.
The researchers found that the primary endpoint occurred in 7.9% of patients who had been randomly assigned to total hip arthroplasty and in 8.3% of those who had been randomly assigned to hemiarthroplasty (hazard ratio, 0.95; P = .79). As for secondary endpoints, mortality did not differ significantly between the two treatment groups (14.3% in the total hip arthroplasty group vs. 13.1% in the hemiarthroplasty group; P = .48), while serious adverse events occurred in 41.8% of patients in the total hip arthroplasty group versus 36.7% of those in the hemiarthroplasty group (HR, 1.16; P = .13).
In other findings, hip instability or dislocation occurred in 4.7% of patients who were assigned to total hip arthroplasty, compared with 2.4% of those who were assigned to hemiarthroplasty (HR, 2.00), while patients who underwent total hip arthroplasty had superior function as measured by the WOMAC total score, pain score, stiffness score, and function score. “These differences between the treatment groups fell below the threshold for a minimal clinically important difference for WOMAC,” the researchers wrote.
They acknowledged certain limitations of the study, including the fact that patients and endpoint assessors were unblinded in the assessments of function, “which left a possibility of bias.” In addition, 14.9% of patients were lost to follow-up for analysis of the primary endpoint.
In an accompanying editorial, Jan-Erik Gjertsen, MD, wrote that one implication of the HEALTH trial is that hemiarthroplasty may provide a satisfactory results for the majority of elderly patients with hip fractures. “Considering the nearly equal risk of secondary surgical procedures and the modest benefit in functional outcome, should we abandon the use of total hip arthroplasty in the treatment of hip fractures?” asked Dr. Gjertsen, of the department of orthopedic surgery at Haukeland University Hospital in Bergen, Norway (N Engl J Med. 2019 Dec 4. doi:10.1056/NEJMe1913800). “Even if the benefits seem smaller than we previously thought, patients with high physical demands and a long remaining life expectancy should probably still be considered for treatment with total hip arthroplasty. Yet the expected remaining lifetime of those patients who potentially could benefit most from a total hip arthroplasty is much longer than the 2-year follow-up period used in the HEALTH trial. However, the number of secondary procedures after hemiarthroplasty may increase with longer follow-up. Therefore, one hopes that the HEALTH investigators will be able to provide long-term results from their trial in the future.”
The HEALTH trial was supported by grants from the Canadian Institutes of Health, the National Institutes of Health, ZorgOnderzoek Nederland/Medische Wetenschappen, the Sophies Minde Foundation for Orthopedic Research, McMaster Surgical Associates, and Stryker Orthopedics. Dr. Bhandari reported receiving grant support and lecture fees from Sanofi, lecture fees from Pendopharm, and grant support from Acumed and Aphria. Dr. Devereaux reported receiving grant support from Abbott Diagnostics, Boehringer Ingelheim, Philips Healthcare, Roche Diagnostics, and Siemens.
SOURCE: Bhandari M et al. N Engl J Med. 2019 Dec 4. doi: 10.1056/NEJMoa1906190.