Mohit Bhandari1, Thomas A Einhorn1, Gordon Guyatt1, Emil H Schemitsch1, Robert D Zura1, Sheila Sprague1, Frede Frihagen1, Ernesto Guerra-Farfán1, Ydo V Kleinlugtenbelt1, Rudolf W Poolman1, Amar Rangan1, Sofia Bzovsky1, Diane Heels-Ansdell1, Lehana Thabane1, Stephen D Walter1, P J Devereaux1. 1. The affiliations of the members of the writing committee are as follows: the Division of Orthopaedic Surgery, Department of Surgery (M.B., S.S., S.B.), the Department of Health Research Methods, Evidence, and Impact (M.B., G.G., S.S., D.H.-A., L.T., S.D.W., P.J.D.), the Department of Medicine (G.G., P.J.D.), and the Population Health Research Institute (P.J.D.), McMaster University, Hamilton, and the Department of Surgery, University of Western Ontario, London (E.H.S.) - all in Ontario, Canada; the Department of Orthopedic Surgery, New York University Langone Medical Center, New York (T.A.E.); the Department of Orthopedic Surgery, Louisiana State University Health Sciences Center, New Orleans (R.D.Z.); the Division of Orthopedic Surgery, Oslo University Hospital, Oslo (F.F.); the Department of Traumatology, Orthopedic Surgery, and Emergency, Hospital Vall d'Hebrón, Barcelona (E.G.-F.); the Department of Orthopedic and Trauma Surgery, Deventer Ziekenhuis, Deventer (Y.V.K.), and the Department of Orthopedic Surgery, OLVG, Amsterdam (R.W.P.) - both in the Netherlands; and the Department of Orthopaedic Surgery, James Cook University Hospital, Middlesbrough, the Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Oxford, and the Department of Health Sciences, University of York, York - all in the United Kingdom (A.R.).
Abstract
BACKGROUND: Globally, hip fractures are among the top 10 causes of disability in adults. For displaced femoral neck fractures, there remains uncertainty regarding the effect of a total hip arthroplasty as compared with hemiarthroplasty. METHODS: We randomly assigned 1495 patients who were 50 years of age or older and had a displaced femoral neck fracture to undergo either total hip arthroplasty or hemiarthroplasty. All enrolled patients had been able to ambulate without the assistance of another person before the fracture occurred. The trial was conducted in 80 centers in 10 countries. The primary end point was a secondary hip procedure within 24 months of follow-up. Secondary end points included death, serious adverse events, hip-related complications, health-related quality of life, function, and overall health end points. RESULTS: The primary end point occurred in 57 of 718 patients (7.9%) who were randomly assigned to total hip arthroplasty and 60 of 723 patients (8.3%) who were randomly assigned to hemiarthroplasty (hazard ratio, 0.95; 95% confidence interval [CI], 0.64 to 1.40; P = 0.79). Hip instability or dislocation occurred in 34 patients (4.7%) assigned to total hip arthroplasty and 17 patients (2.4%) assigned to hemiarthroplasty (hazard ratio, 2.00; 99% CI, 0.97 to 4.09). Function, as measured with the total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score, pain score, stiffness score, and function score, modestly favored total hip arthroplasty over hemiarthroplasty. Mortality was similar in the two treatment groups (14.3% among the patients assigned to total hip arthroplasty and 13.1% among those assigned to hemiarthroplasty, P = 0.48). Serious adverse events occurred in 300 patients (41.8%) assigned to total hip arthroplasty and in 265 patients (36.7%) assigned to hemiarthroplasty. CONCLUSIONS: Among independently ambulating patients with displaced femoral neck fractures, the incidence of secondary procedures did not differ significantly between patients who were randomly assigned to undergo total hip arthroplasty and those who were assigned to undergo hemiarthroplasty, and total hip arthroplasty provided a clinically unimportant improvement over hemiarthroplasty in function and quality of life over 24 months. (Funded by the Canadian Institutes of Health Research and others; ClinicalTrials.gov number, NCT00556842.).
RCT Entities:
BACKGROUND: Globally, hip fractures are among the top 10 causes of disability in adults. For displaced femoral neck fractures, there remains uncertainty regarding the effect of a total hip arthroplasty as compared with hemiarthroplasty. METHODS: We randomly assigned 1495 patients who were 50 years of age or older and had a displaced femoral neck fracture to undergo either total hip arthroplasty or hemiarthroplasty. All enrolled patients had been able to ambulate without the assistance of another person before the fracture occurred. The trial was conducted in 80 centers in 10 countries. The primary end point was a secondary hip procedure within 24 months of follow-up. Secondary end points included death, serious adverse events, hip-related complications, health-related quality of life, function, and overall health end points. RESULTS: The primary end point occurred in 57 of 718 patients (7.9%) who were randomly assigned to total hip arthroplasty and 60 of 723 patients (8.3%) who were randomly assigned to hemiarthroplasty (hazard ratio, 0.95; 95% confidence interval [CI], 0.64 to 1.40; P = 0.79). Hip instability or dislocation occurred in 34 patients (4.7%) assigned to total hip arthroplasty and 17 patients (2.4%) assigned to hemiarthroplasty (hazard ratio, 2.00; 99% CI, 0.97 to 4.09). Function, as measured with the total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score, pain score, stiffness score, and function score, modestly favored total hip arthroplasty over hemiarthroplasty. Mortality was similar in the two treatment groups (14.3% among the patients assigned to total hip arthroplasty and 13.1% among those assigned to hemiarthroplasty, P = 0.48). Serious adverse events occurred in 300 patients (41.8%) assigned to total hip arthroplasty and in 265 patients (36.7%) assigned to hemiarthroplasty. CONCLUSIONS: Among independently ambulating patients with displaced femoral neck fractures, the incidence of secondary procedures did not differ significantly between patients who were randomly assigned to undergo total hip arthroplasty and those who were assigned to undergo hemiarthroplasty, and total hip arthroplasty provided a clinically unimportant improvement over hemiarthroplasty in function and quality of life over 24 months. (Funded by the Canadian Institutes of Health Research and others; ClinicalTrials.gov number, NCT00556842.).
Authors: Ryan D DeAngelis; Matthew K Stein; Gregory T Minutillo; Nikhilesh G Mehta; Emil H Schemitsch; Sofia Bzovsky; Sheila Sprague; Mohit Bhandari; Marc Swiontkowski; Derek J Donegan; Samir Mehta Journal: J Orthop Trauma Date: 2022-04-01 Impact factor: 2.512
Authors: Guillermo Pechero; Branden Pfaff; Mayank Rao; David Pogorzelski; Paula McKay; Ella Spicer; Andrea Howe; Haley K Demyanovich; Debra L Sietsema; Michael F McTague; Lolita Ramsey; Martha Holden; Joshua Rudnicki; Jeff Wells; Michelle Medeiros; Gerard P Slobogean; Sheila Sprague; Gerard P Slobogean; Sheila Sprague; Jeffrey Wells; Mohit Bhandari; Robert V O'Toole; Jean-Claude D'Alleyrand; Andrew Eglseder; Aaron Johnson; Christopher Langhammer; Christopher Lebrun; Theodore Manson; Jason Nascone; Ebrahim Paryavi; Raymond Pensy; Andrew Pollak; Marcus Sciadini; Gerard P Slobogean; Yasmin Degani; Haley K Demyanovich; Andrea Howe; Nathan N O'Hara; Katherine Joseph; Joshua Rudnicki; Megan Camara Journal: Contemp Clin Trials Commun Date: 2021-06-14