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Hip Fracture Evaluation with Alternatives of Total Hip Arthroplasty Versus Hemiarthroplasty (HEALTH): Protocol for a Multicentre Randomised Trial Mohit Bhandari

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Hip Fracture Evaluation with Alternatives of Total Hip Arthroplasty Versus Hemiarthroplasty (HEALTH): Protocol for a Multicentre Randomised Trial Mohit Bhandari Marshall University Marshall Digital Scholar Orthopaedics Faculty Research Winter 12-11-2014 Hip fracture evaluation with alternatives of total hip arthroplasty versus hemiarthroplasty (HEALTH): protocol for a multicentre randomised trial Mohit Bhandari P. J. Devereaux Thomas A. Einhorn Lehana Thabane Emil H. Schemitsch See next page for additional authors Follow this and additional works at: http://mds.marshall.edu/sm_orthopaedics Part of the Orthopedics Commons Recommended Citation Bhandari M, Devereaux PJ, Einhorn TA, et al. Hip fracture evaluation with alternatives of total hip arthroplasty versus hemiarthroplasty (HEALTH): protocol for a multicentre randomised trial. BMJ Open 2015;5:e006263. doi:10.1136/bmjopen-2014- 006263 This Article is brought to you for free and open access by the Faculty Research at Marshall Digital Scholar. It has been accepted for inclusion in Orthopaedics by an authorized administrator of Marshall Digital Scholar. For more information, please contact [email protected]. Authors Mohit Bhandari, P. J. Devereaux, Thomas A. Einhorn, Lehana Thabane, Emil H. Schemitsch, Kenneth J. Koval, Frede Frihagen, Rudolf W. Poolman, Kevin Tetsworth, Ernesto Guerra-Farfán, Kim Madden, Sheila Sprague, Gordon Guyatt, Ali Oliasharazi, Franklin D. Shuler, Jonathon Salva, James Day, Tigran Garabekyan, Felix Cheung, Linda Morgan, Timothy Wilson-Byrne MD, and Mary Beth Cordle This article is available at Marshall Digital Scholar: http://mds.marshall.edu/sm_orthopaedics/14 Downloaded from http://bmjopen.bmj.com/ on October 30, 2015 - Published by group.bmj.com Open Access Protocol Hip fracture evaluation with alternatives of total hip arthroplasty versus hemiarthroplasty (HEALTH): protocol for a multicentre randomised trial Mohit Bhandari,1 P J Devereaux,2 Thomas A Einhorn,3 Lehana Thabane,4 Emil H Schemitsch,5 Kenneth J Koval,6 Frede Frihagen,7 Rudolf W Poolman,8 Kevin Tetsworth,9 Ernesto Guerra-Farfán,10 Kim Madden,11 Sheila Sprague,12 Gordon Guyatt,4 HEALTH Investigators To cite: Bhandari M, ABSTRACT Strengths and limitations of this study Devereaux PJ, Einhorn TA, Introduction: Hip fractures are a leading cause of et al. Hip fracture evaluation mortality and disability worldwide, and the number of ▪ with alternatives of total hip This study has a large sample size of 1434 hip fractures is expected to rise to over 6 million per arthroplasty versus patients in order to detect small but important hemiarthroplasty (HEALTH): year by 2050. The optimal approach for the surgical differences in outcomes. protocol for a multicentre management of displaced femoral neck fractures ▪ We are utilising an expertise-based randomised randomised trial. BMJ Open remains unknown. Current evidence suggests the use controlled trial design to help to eliminate differ- 2015;5:e006263. of arthroplasty; however, there is lack of evidence ential performance and differential outcome doi:10.1136/bmjopen-2014- regarding whether patients with displaced femoral neck assessments, and to reduce crossovers and 006263 fractures experience better outcomes with total hip ethical concerns associated with randomisation. arthroplasty (THA) or hemiarthroplasty (HA). The ▪ The study has stringent methodological safe- ▸ Prepublication history for HEALTH trial compares outcomes following THA versus guards against bias including: use of a centra- this paper is available online. HA in patients 50 years of age or older with displaced lised randomisation system; blinding data To view these files please femoral neck fractures. analysts and the Steering Committee; standard- visit the journal online Methods and analysis: HEALTH is a multicentre, isation and documentation; use of strategies to (http://dx.doi.org/10.1136/ randomised controlled trial where 1434 patients, limit loss to follow-up; and adjudication of trial bmjopen-2014-006263). 50 years of age or older, with displaced femoral neck events by an independent Central Adjudication Received 13 August 2014 fractures from international sites are randomised to Committee. Revised 25 November 2014 receive either THA or HA. Exclusion criteria include ▪ Surgeons and patients cannot be blinded to the Accepted 11 December 2014 associated major injuries of the lower extremity, hip surgical arms, leaving the assessment of out- infection(s) and a history of frank dementia. The comes and decisions to reoperate vulnerable to primary outcome is unplanned secondary procedures bias. and the secondary outcomes include functional ▪ We do not allow family members and friends to outcomes, patient quality of life, mortality and hip- answer questionnaires on behalf of cognitively related complications—both within 2 years of the initial impaired patients; so some secondary outcomes surgery. We are using minimisation to ensure balance will only apply to patients who are not cogni- between intervention groups for the following factors: tively impaired. age, prefracture living, prefracture functional status, ▪ The 2-year follow-up limits the study to shorter American Society for Anesthesiologists (ASA) Class term outcomes. and centre number. Data analysts and the HEALTH Steering Committee are blinded to the surgical allocation throughout the trial. Outcome analysis will results with patients who have indicated an interest in be performed using a χ2 test (or Fisher’s exact test) knowing the results. and Cox proportional hazards modelling estimate. All Trial registration number: The HEALTH trial is results will be presented with 95% CIs. registered with clinicaltrials.gov (NCT00556842). Ethics and dissemination: The HEALTH trial has received local and McMaster University Research Ethics For numbered affiliations see Board (REB) approval (REB#: 06-151). end of article. Results: Outcomes from the primary manuscript will be disseminated through publications in academic INTRODUCTION Correspondence to journals and presentations at relevant orthopaedic The number of hip fractures globally is Dr Mohit Bhandari; conferences. We will communicate trial results to all expected to rise to over 6 million by the year [email protected] participating sites. Participating sites will communicate 2050.12Owing to projected ageing of the Bhandari M, et al. BMJ Open 2015;5:e006263. doi:10.1136/bmjopen-2014-006263 1 Downloaded from http://bmjopen.bmj.com/ on October 30, 2015 - Published by group.bmj.com Open Access population, the number of hip fractures is likely to International, 94–96% of surgeons agreed that arthro- exceed 500 000 annually in the USA and 88 000 in plasty is the preferred treatment option in patients over – Canada over the next 40 years.3 5 By the year 2040, the 80 years of age with displaced femoral neck fractures.14 estimated annual healthcare costs associated with hip In addition, 73% of surgeons surveyed preferred HA to fractures will reach $9.8 billion in the USA and $650 THA.14 In summary, current evidence suggests substan- million in Canada.6 Hip fractures account for more hos- tial benefits of THA over HA through decreased pain pital days than any other musculoskeletal injury and rep- and improved function, but also increased rates of dis- resent more than two-thirds of all hospital days due to location associated with THA, with similar rates of sec- fractures.7 In the elderly, hip fractures are associated ondary procedures and mortality with the two with a 30% mortality rate of 1 year postinjury, and tem- procedures. Despite the apparent benefits of THA over porary8 and often permanent impairment of independ- HA, surgeons more often prefer HA to treat displaced ence and quality of life.910Worldwide, 4.5 million femoral neck fractures. Previous trials comparing these people are disabled from hip fractures yearly; the two approaches were limited by methodological issues; number of persons living with disability is expected to therefore, the current trial aims to determine the effect- increase to 21 million in the next 40 years.135The dis- iveness of THA compared to HA using a large sample ability adjusted life-years lost as a result of hip fractures size and high-quality methodology. ranks in the top 10 of all causes of global disability.3 Study objectives Inconclusive clinical evidence Our primary objective is to assess the impact of THA Femoral neck fractures may be either non-displaced versus HA on rates of unplanned secondary procedures (ie, very little separation at the fracture site, about within 2 years for individuals with displaced femoral one-third of femoral neck fractures) or displaced (ie, neck fractures. greater separation at the fracture site, about two-thirds Secondary objectives are: of femoral neck fractures). Orthopaedic surgeons often 1. To examine the effect of THA versus HA on fi treat non-displaced fractures with internal xation and health-related quality of life (Short Form-12, SF-12), displaced fractures with arthroplasty, which is also known functional outcomes and mobility (Western Ontario as joint replacement. McMaster Osteoarthritis Index, WOMAC, and Timed We conducted a comprehensive literature search to Up and Go Test, TUG), and health outcome mea- identify all studies investigating total hip arthroplasty sures (EuroQol-5 Dimensions, EQ-5D) (THA; involves replacing the femoral head and the acet- 2. To evaluate the effect of THA versus HA on mortality abulum) compared to hemiarthroplasty (HA; involves 3. To evaluate the effect of THA versus HA on hip- replacing the femoral head only) for displaced femoral related complications, including periprosthetic frac- fi neck fractures. We identi ed a recent meta-analysis
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