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Grant: Operating Grant

McMaster University

$1,434,596.00

Hip Fracture Evaluation with ALternatives of Total Hip Arthroplasty versus Hemi-Arthroplasty (HEALTH): A Multi-Centre Randomized Trial Comparing Total Hip Arthroplasty and Hemi-Arthroplasty on Revision Surgery and Quality of Life in Patients with Displaced Femoral Neck Fractures

EF 2012-13

Résumé
Hip fractures occur in 280,000 Americans and 36,000 Canadians annually. The number of hip fractures is likely to exceed 500,000 a year in the United States and 88,000 a year in Canada. Hip fractures are associated with serious temporary and sometimes permanent impairment of independence and quality of life. Hip fractures can be fixed with partial (hemi) or total hip replacement (arthroplasty). Some surgeons support hemi-hip arthroplasty (HA) because it can reduce dislocation, deep vein thrombosis, lessen blood loss, shorten operating times, and is a technically less demanding procedure. Others support total hip arthroplasty (THA) because they believe it improves patient function and quality of life. Previous hip fracture trials have had study design limitations, specifically small sample sizes and surgeon expertise, leading to less certainty in the study results. This has left the best surgical approach for displaced femoral neck fractures unresolved. Therefore we propose a large multi-centre, concealed expertise-based randomized trial design that includes 1,434 patients assigned to treatments performed by surgeons considered to have expertise in the surgery to which the patient has been randomized, or who has expertise in both procedures. Surgeons across North America, Europe, Australia, and Asia will participate. Study personnel will monitor critical aspects of peri-operative care and rehabilitation. The primary outcome is revision surgery within 2 years of the arthroplasty. The secondary outcomes include health-related quality of life, functional outcomes and mobility, and health-related quality of life. We will assess patients at hospital admission, 1 week, 10 weeks, 6 months, 9 months, 12 months, 18 months, and 24 months after surgery. This trial will not only change current orthopaedic practice, but will set a benchmark for the conduct of future orthopaedic trials.
Programme
Operating Grant
Bénéficiaire
Emplacement
Ontario, Canada
Type de bénéficiaire
Academia
Type
Grant
Source
CIHR Funding Decisions Database

Tel que publié

Id
266500
Name
Bhandari Mohit
Region
Ontario
Country
Canada
Orgtype
Institution Paid; Research Institution
Instname2
Musculoskeletal Health and Arthritis
Theme2
Clinical
Prcname2
Randomized Controlled Trials
Projecttitle
Hip Fracture Evaluation with ALternatives of Total Hip Arthroplasty versus Hemi-Arthroplasty (HEALTH): A Multi-Centre Randomized Trial Comparing Total Hip Arthroplasty and Hemi-Arthroplasty on Revision Surgery and Quality of Life in Patients with Displaced Femoral Neck Fractures
Programtype2
Operating Grants
Orgnameinp2
McMaster University
Cihramount2
$1,434,596
Cihrequipment2
$0
Programname2
Operating Grant
Keyworddelim
Expertise-Based; Hemi-Arthroplasty; Hip Fracture; Multi Centre; Orthopaedics; Randomized Controlled Trial; Total Hip Arthroplasty
Abstract
Hip fractures occur in 280,000 Americans and 36,000 Canadians annually. The number of hip fractures is likely to exceed 500,000 a year in the United States and 88,000 a year in Canada. Hip fractures are associated with serious temporary and sometimes permanent impairment of independence and quality of life. Hip fractures can be fixed with partial (hemi) or total hip replacement (arthroplasty). Some surgeons support hemi-hip arthroplasty (HA) because it can reduce dislocation, deep vein thrombosis, lessen blood loss, shorten operating times, and is a technically less demanding procedure. Others support total hip arthroplasty (THA) because they believe it improves patient function and quality of life. Previous hip fracture trials have had study design limitations, specifically small sample sizes and surgeon expertise, leading to less certainty in the study results. This has left the best surgical approach for displaced femoral neck fractures unresolved. Therefore we propose a large multi-centre, concealed expertise-based randomized trial design that includes 1,434 patients assigned to treatments performed by surgeons considered to have expertise in the surgery to which the patient has been randomized, or who has expertise in both procedures. Surgeons across North America, Europe, Australia, and Asia will participate. Study personnel will monitor critical aspects of peri-operative care and rehabilitation. The primary outcome is revision surgery within 2 years of the arthroplasty. The secondary outcomes include health-related quality of life, functional outcomes and mobility, and health-related quality of life. We will assess patients at hospital admission, 1 week, 10 weeks, 6 months, 9 months, 12 months, 18 months, and 24 months after surgery. This trial will not only change current orthopaedic practice, but will set a benchmark for the conduct of future orthopaedic trials.
Competitiondate
201209
Approvedterm2
4 yrs 0 mth
Pinamesdelim
Bhandari, Mohit; Devereaux, Philip J; Guyatt, Gordon H
Approvedterm
4 ans 0 mois
Cihrcontribution2
~ $1,434,596~ $0~