Hip fracture evaluation with alternatives of total hip arthroplasty versus hemiarthroplasty (HEALTH): protocol for a multicentre randomised trial

被引:54
作者
Bhandari, Mohit [1 ]
Devereaux, P. J. [2 ]
Einhorn, Thomas A. [3 ]
Thabane, Lehana [4 ]
Schemitsch, Emil H. [5 ]
Koval, Kenneth J. [6 ]
Frihagen, Frede [7 ]
Poolman, Rudolf W. [8 ]
Tetsworth, Kevin [9 ]
Guerra-Farfan, Ernesto [10 ]
Madden, Kim
Sprague, Sheila [11 ]
Guyatt, Gordon [4 ]
机构
[1] McMaster Univ, Dept Surg, Hamilton, ON L8S 4L8, Canada
[2] McMaster Univ, Dept Med, Hamilton, ON, Canada
[3] Boston Univ, Med Ctr, Boston, MA 02215 USA
[4] McMaster Univ, Dept Clin Epidemiol & Biostat, Hamilton, ON, Canada
[5] St Michaels Hosp, Toronto, ON M5B 1W8, Canada
[6] Orlando Reg Med Ctr Inc, Dept Orthopaed Surg, Orlando, FL USA
[7] Ullevaal Univ Hosp, Orthopaed Ctr, Oslo, Norway
[8] Univ Amsterdam, Onze Lieve Vrouwe Gasthuis, Dept Orthopaed Surg, Amsterdam, Netherlands
[9] Univ Queensland, Brisbane, Qld 4072, Australia
[10] Univ Hosp Vall Hebron, Dept Traumatol Orthopaed Surg & Emergency, Barcelona, Spain
[11] McMaster Univ, Hamilton, ON, Canada
基金
加拿大健康研究院; 美国国家卫生研究院;
关键词
FEMORAL-NECK FRACTURES; DISPLACED INTRACAPSULAR FRACTURE; BIPOLAR HEMIARTHROPLASTY; INTERNAL-FIXATION; REPLACEMENT; OUTCOMES; GO; OSTEOARTHRITIS; ASSOCIATION; RELIABILITY;
D O I
10.1136/bmjopen-2014-006263
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Introduction: Hip fractures are a leading cause of mortality and disability worldwide, and the number of hip fractures is expected to rise to over 6 million per year by 2050. The optimal approach for the surgical management of displaced femoral neck fractures remains unknown. Current evidence suggests the use of arthroplasty; however, there is lack of evidence regarding whether patients with displaced femoral neck fractures experience better outcomes with total hip arthroplasty (THA) or hemiarthroplasty (HA). The HEALTH trial compares outcomes following THA versus HA in patients 50 years of age or older with displaced femoral neck fractures. Methods and analysis: HEALTH is a multicentre, randomised controlled trial where 1434 patients, 50 years of age or older, with displaced femoral neck fractures from international sites are randomised to receive either THA or HA. Exclusion criteria include associated major injuries of the lower extremity, hip infection(s) and a history of frank dementia. The primary outcome is unplanned secondary procedures and the secondary outcomes include functional outcomes, patient quality of life, mortality and hip-related complications-both within 2 years of the initial surgery. We are using minimisation to ensure balance between intervention groups for the following factors: age, prefracture living, prefracture functional status, American Society for Anesthesiologists (ASA) Class and centre number. Data analysts and the HEALTH Steering Committee are blinded to the surgical allocation throughout the trial. Outcome analysis will be performed using a.2 test (or Fisher's exact test) and Cox proportional hazards modelling estimate. All results will be presented with 95% CIs. Ethics and dissemination: The HEALTH trial has received local and McMaster University Research Ethics Board (REB) approval (REB#: 06-151). Results: Outcomes from the primary manuscript will be disseminated through publications in academic journals and presentations at relevant orthopaedic conferences. We will communicate trial results to all participating sites. Participating sites will communicate results with patients who have indicated an interest in knowing the results.
引用
收藏
页数:12
相关论文
共 43 条
[1]  
American Academy of Orthopaedic Surgeons, 1999, AM ACAD ORTHOP SURG, V47
[2]  
[Anonymous], 1994, Modelling Survival Data in Medical Research
[3]   Total hip arthroplasty and hemiarthroplasty in mobile, independent patients with a displaced intracapsular fracture of the femoral neck - A randomized, controlled trial [J].
Baker, R. P. ;
Squires, B. ;
Gargan, M. F. ;
Bannister, G. C. .
JOURNAL OF BONE AND JOINT SURGERY-AMERICAN VOLUME, 2006, 88A (12) :2583-2589
[4]  
BELLAMY N, 1988, J RHEUMATOL, V15, P1833
[5]   Operative management of displaced femoral neck fractures in elderly patients - An international survey [J].
Bhandari, M ;
Devereaux, PJ ;
Tornetta, P ;
Swiontkowski, MF ;
Berry, DJ ;
Haidukewych, G ;
Schemitsch, EH ;
Hanson, BP ;
Koval, K ;
Dirschl, D ;
Leece, P ;
Keel, M ;
Petrisor, B ;
Heetveld, M ;
Guyatt, GH .
JOURNAL OF BONE AND JOINT SURGERY-AMERICAN VOLUME, 2005, 87A (09) :2122-2130
[6]   A randomised controlled trial comparing bipolar hemiarthroplasty with total hip replacement for displaced intracapsular fractures of the femoral neck in elderly patients [J].
Blomfeldt, R. ;
Tornkvist, H. ;
Eriksson, K. ;
Soderqvist, A. ;
Ponzer, S. ;
Tidermark, J. .
JOURNAL OF BONE AND JOINT SURGERY-BRITISH VOLUME, 2007, 89B (02) :160-165
[7]   Stopping randomized trials early for benefit: a protocol of the Study Of Trial Policy Of Interim Truncation-2 (STOPIT-2) [J].
Briel, Matthias ;
Lane, Melanie ;
Montori, Victor M. ;
Bassler, Dirk ;
Glasziou, Paul ;
Malaga, German ;
Akl, Elie A. ;
Ferreira-Gonzalez, Ignacio ;
Alonso-Coello, Pablo ;
Urrutia, Gerard ;
Kunz, Regina ;
Culebro, Carolina Ruiz ;
da Silva, Suzana Alves ;
Flynn, David N. ;
Elamin, Mohamed B. ;
Strahm, Brigitte ;
Murad, M. Hassan ;
Djulbegovic, Benjamin ;
Adhikari, Neill K. J. ;
Mills, Edward J. ;
Gwadry-Sridhar, Femida ;
Kirpalani, Haresh ;
Soares, Heloisa P. ;
Abu Elnour, Nisrin O. ;
You, John J. ;
Karanicolas, Paul J. ;
Bucher, Heiner C. ;
Lampropulos, Julianna F. ;
Nordmann, Alain J. ;
Burns, Karen E. A. ;
Mulla, Sohail M. ;
Raatz, Heike ;
Sood, Amit ;
Kaur, Jagdeep ;
Bankhead, Clare R. ;
Mullan, Rebecca J. ;
Nerenberg, Kara A. ;
Vandvik, Per Olav ;
Coto-Yglesias, Fernando ;
Schuenemann, Holger ;
Tuche, Fabio ;
Chrispim, Pedro Paulo M. ;
Cook, Deborah J. ;
Lutz, Kristina ;
Ribic, Christine M. ;
Vale, Noah ;
Erwin, Patricia J. ;
Perera, Rafael ;
Zhou, Qi ;
Heels-Ansdell, Diane .
TRIALS, 2009, 10
[8]  
Brooks R., 2003, MEASUREMENT VALUATIO
[9]   Total hip arthroplasty versus hemiarthroplasty for displaced femoral neck fractures in the healthy elderly: a meta-analysis and systematic review of randomized trials [J].
Burgers, Paul T. P. W. ;
Van Geene, Arnoud R. ;
Van den Bekerom, Michel P. J. ;
Van Lieshout, Esther M. M. ;
Blom, Bastiaan ;
Aleem, Ilyas S. ;
Bhandari, M. ;
Poolman, Rudolf W. .
INTERNATIONAL ORTHOPAEDICS, 2012, 36 (08) :1549-1560
[10]  
CALLAGHAN JJ, 1992, CLIN ORTHOP RELAT R, P132