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1. Fracture fixation in the operative management of hip fractures (FAITH) : an international, multicentre, randomised controlled trial

Author

Nauth, Aaron, Creek, Aaron T., Zellar, Abby, Lawendy, Abdel Rahman, Dowrick, Adam, Gupta, Ajay, Dadi, Akhil, van Kampen, Albert, Yee, Albert, de Vries, Alexander C., de Mol van Otterloo, Alexander, Garibaldi, Alisha, Liew, Allen, McIntyre, Allison W., Prasad, Amal Shankar, Romero, Amanda W., Rangan, Amar, Oatt, Amber, Sanghavi, Amir, Foley, Amy L., Karlsten, Anders, Dolenc, Andrea, Bucknill, Andrew, Chia, Andrew, Evans, Andrew, Gong, Andrew, Schmidt, Andrew H., Marcantonio, Andrew J., Jennings, Andrew, Ward, Angela, Khanna, Angshuman, Rai, Anil, Smits, Anke B, Horan, Annamarie D., Brekke, Anne Christine, Flynn, Annette, Duraikannan, Aravin, Stødle, Are, van Vugt, Arie B., Luther, Arlene, Zurcher, Arthur W., Jain, Arvind, Amundsen, Asgeir, Moaveni, Ash, van der Pol, Carmen C., Meijer, Joost, van Wessem, Karlijn, Leenen, Luke P.H., Simmermacher, Rogier K J, Blokhuis, Taco J., and Fixation using Alternative Implants for the Treatment of Hip fractures (FAITH) Investigators

Subjects
Aged, 80 and over, Fracture Healing, Male, Research Support, Non-U.S. Gov't, Bone Screws, Femoral Neck Fractures/surgery, Equipment Design, Kaplan-Meier Estimate, Femur Head Necrosis/etiology, Multicenter Study, Reoperation/statistics & numerical data, Treatment Outcome, Research Support, N.I.H., Extramural, Randomized Controlled Trial, Quality of Life, Journal Article, Humans, Female, Fracture Fixation, Internal/adverse effects, Single-Blind Method, Aged
Abstract

Background Reoperation rates are high after surgery for hip fractures. We investigated the effect of a sliding hip screw versus cancellous screws on the risk of reoperation and other key outcomes. Methods For this international, multicentre, allocation concealed randomised controlled trial, we enrolled patients aged 50 years or older with a low-energy hip fracture requiring fracture fixation from 81 clinical centres in eight countries. Patients were assigned by minimisation with a centralised computer system to receive a single large-diameter screw with a side-plate (sliding hip screw) or the present standard of care, multiple small-diameter cancellous screws. Surgeons and patients were not blinded but the data analyst, while doing the analyses, remained blinded to treatment groups. The primary outcome was hip reoperation within 24 months after initial surgery to promote fracture healing, relieve pain, treat infection, or improve function. Analyses followed the intention-to-treat principle. This study was registered with ClinicalTrials.gov, number NCT00761813. Findings Between March 3, 2008, and March 31, 2014, we randomly assigned 1108 patients to receive a sliding hip screw (n=557) or cancellous screws (n=551). Reoperations within 24 months did not differ by type of surgical fixation in those included in the primary analysis: 107 (20%) of 542 patients in the sliding hip screw group versus 117 (22%) of 537 patients in the cancellous screws group (hazard ratio [HR] 0·83, 95% CI 0·63–1·09; p=0·18). Avascular necrosis was more common in the sliding hip screw group than in the cancellous screws group (50 patients [9%] vs 28 patients [5%]; HR 1·91, 1·06–3·44; p=0·0319). However, no significant difference was found between the number of medically related adverse events between groups (p=0·82; appendix); these events included pulmonary embolism (two patients [

Published
2017

2. Fixation using alternative implants for the treatment of hip fractures (FAITH): design and rationale for a multi-centre randomized trial comparing sliding hip screws and cancellous screws on revision surgery rates and quality of life in the treatment of femoral neck fractures

Author

McCormack, Robert, Apostle, Kelly, Moon, Raely, Bielby, Shea A., Switzer, Julie A., Cole, Peter A., Anderson, Sarah A., Lafferty, Paul M., Li, Mengnai, Ly, Thuan V., Marston, Scott B., Foley, Amy L., Vang, Sandy, Oatt, Amber, Wright, David M., Marcantonio, Andrew J., Kain, Michael S. H., Iorio, Richard, Specht, Lawrence M., Tilzey, John F., Lobo, Margaret J., Garfi, John S., Vallier, Heather A., Dolenc, Andrea, Buckley, Richard E., Robinson, Chalitha, Prayson, Michael J., Laughlin, Richard, Rubino, L. Joseph, May, Jedediah, Rieser, Geoffrey Ryan, Dulaney-Cripe, Liz, Gayton, Chris, Shaer, James, Schrickel, Tyson, Duffy, Paul, Hileman, Barbara, Gorczyca, John T., Gross, Jonathan M., Humphrey, Catherine A., Kates, Stephen, Noble, Krista, McIntyre, Allison W., Pecorella, Kaili, Davis, Craig A., Weinerman, Stewart, Korley, Robert, Weingarten, Peter, Stull, Philip, Lindenbaum, Stephen, Hewitt, Michael, Schwappach, John, Baker, Janell K., Rutherford, Tori, Newman, Heike, Lieberman, Shane, Finn, Erin, Puloski, Shannon, Robbins, Kristin, Hurley, Meghan, Lyle, Lindsey, Mitchell, Khalis, Browner, Kieran, Whatley, Erica, Payton, Krystal, Reeves, Christina, Cannada, Lisa K., Karges, David, Johnston, Kelly, Hill, Leslie, Mehta, Samir, Esterhai, John, Ahn, Jaimo, Horan, Annamarie D., McGinnis, Kelly, Kaminski, Christine A., Kowalski, Brynn N., Keeve, Jonathan P., Anderson, Christopher G., Powell, James, McDonald, Michael D., Hoffman, Jodi M., Tarkin, Ivan, Siska, Peter, Gruen, Gary, Evans, Andrew, Farrell, Dana J., Irrgang, James, Luther, Arlene, Cross III., William W., Carcary, Kimberly, Cass, Joseph R., Sems, Stephen A., Torchia, Michael E., Scrabeck, Tyson, Jenkins, Mark, Dumais, Jules, Romero, Amanda W., Sagebien, Carlos A., Butler, Mark S., Monica, James T., Sanders, David, Seuffert, Patricia, Hsu, Joseph R., Ficke, James, Charlton, Michael, Napierala, Matthew, Fan, Mary, Tornetta III., Paul, Tannoury, Chadi, Carlisle, Hope, Silva, Heather, Boyer, Dory, Lawendy, Abdel, Archdeacon, Michael, Finnan, Ryan, Le, Toan, Wyrick, John, Hess, Shelley, Brennan, Michael L., Probe, Robert, Kile, Evelyn, Mills, Kelli, Clipper, Lydia, Tieszer, Christina, Yu, Michelle, Erwin, Katie, Horwitz, Daniel, Strohecker, Kent, Swenson, Teresa K., Aurang, Kamran, Zohman, Gary, Peterson, Brett, Huff, Roger B., Baele, Joseph, Stephen, David, Weber, Timothy, Edison, Matt, McBeth, Jessica, Shively, Karl, Ertl, Janos P., Mullis, Brian, Parr, J. Andrew, Worman, Ripley, Frizzell, Valda, Moore, Molly M., Kreder, Hans, Tobias, Erin, Thomas, Emily, DePaolo, Charles J., Alosky, Rachel, Shell, Leslie E., Hampton, Lynne, Shepard, Stephanie, Nanney, Tracy, Cuento, Claudine, Cantu, Robert V., Jenkinson, Richard, Henderson, Eric R., Eickhoff, Linda S., Hammerberg, E. Mark, Stahel, Philip, Hak, David, Mauffrey, Cyril, Gibula, Douglas, Gissel, Hannah, Henderson, Corey, Zamorano, David P., Nousiainen, Markku, Tynan, Martin C., Pourmand, Deeba, Lawson, Deanna, Della Rocca, Gregory J., Crist, Brett D., Murtha, Yvonne M., Anderson, Linda K., Linehan, Colleen, Pilling, Lindsey, Lewis, Courtland G., Axelrod, Terry, Caminiti, Stephanie, Sullivan, Raymond J., Roper, Elizabeth, Obremskey, William, Kregor, Philip, Richards, Justin E., Stringfellow, Kenya, Dohm, Michael P., Zellar, Abby, Segers, Michiel J. M., Murnaghan, John, Zijl, Jacco A. C., Verhoeven, Bart, Smits, Anke B., de Vries, Jean Paul P. M., Fioole, Bram, van der Hoeven, Henk, Theunissen, Evert B. M., de Vries Reilingh, Tammo S., Govaert, Lonneke, Wittich, Philippe, Nam, Diane, de Brauw, Maurits, Wille, Jan, Go, Peter M. N. Y. M., Ritchie, Ewan D., Wessel, Ronald N., Hammacher, Eric R., Heetveld, Martin J., Visser, Gijs A., Stockmann, Heyn, Silvis, Rob, Wadey, Veronica, Snellen, Jaap P., Rijbroek, Bram, Scheepers, Joris J. G., Vermeulen, Erik G. J., Siroen, Michiel P. C., Vuylsteke, Ronald, Brom, Hans L. F., Rijna, Herman, de Rijcke, Piet A. R., Koppert, Cees L., Moola, Farhad, Yee, Albert, Buijk, Steven E., Groenendijk, Richard P. R., Dawson, Imro, Tetteroo, Geert W. M., Bruijninckx, Milko M. M., Doornebosch, Pascal G., de Graaf, Eelco J. R., van der Elst, Maarten, van der Pol, Carmen C., van 't Riet, Martijne, Milner, Katrine, Karsten, Tom M., de Vries, Mark R., Stassen, Laurents P. S., Schep, Niels W. L., Schmidt, G. Ben, Hoffman, W. H., Poolman, Rudolf W., Simons, Maarten P., van der Heijden, Frank H. W. M., Willems, W. Jaap, Kunz, Monica, de Meulemeester, Frank R. A. J., van der Hart, Cor P., Turckan, Kahn, Festen, Sebastiaan, de Nies, Frank, Haverlag, Robert, Out, Nico J. M., Bosma, Jan, van Kampen, Albert, Biert, Jan, Schemitsch, Emil H., van Vugt, Arie B., Edwards, Michael J. R., Blokhuis, Taco J., Frolke, Jan Paul M., Geeraedts, Leo M. G., Gardeniers, Jean W. M., Tan, Edward T. C. H., Poelhekke, Lodewijk M. S. J., de Waal Malefijt, Maarten C., Schreurs, Bart, Ahn, Henry, Roukema, Gert R., Josaputra, Hong A., Keller, Paul, de Rooij, Peter D., Kuiken, Hans, Boxma, Han, Cleffken, Berry I., Liem, Ronald, Rhemrev, Steven J., Bosman, Coks H. R., Hall, Jeremy A., de Mol van Otterloo, Alexander, Hoogendoorn, Jochem, de Vries, Alexander C., Meylaerts, Sven A. G., Verhofstad, Michiel H. J., Meijer, Joost, van Egmond, Teun, van der Brand, Igor, Patka, Peter, McKee, Michael D., Eversdijk, Martin G., Peters, Rolf, Den Hartog, Dennis, Van Waes, Oscar J. F., Oprel, Pim, van der Vis, Harm M., Campo, Martin, Verhagen, Ronald, Albers, G. H. Robert, Zurcher, Arthur W., Whelan, Daniel B., Simmermacher, Rogier K. J., van Mulken, Jeroen, van Wessem, Karlijn, van Gaalen, Steven M., Leenen, Luke, Bronkhorst, Maarten W. G. A., Guicherit, Onno R., Goslings, J. Carel, Nauth, Aaron, Ponsen, Kees Jan, Bhatia, Mahesh, Arora, Vinod, Tyagi, Vivek, Liew, Susan, Bedi, Harvinder, Carr, Ashley, Curry, Hamish, Chia, Andrew, Csongvay, Steve, Vicente, Milena R., Donohue, Craig, Doig, Stephen, Edwards, Elton, Etherington, Greg, Esser, Max, Gong, Andrew, Jain, Arvind, Li, Doug, Miller, Russell, Moaveni, Ash, Perey, Bertrand, Wild, Lisa M., Russ, Matthias, Ton, Lu, Wang, Otis, Dowrick, Adam, Murdoch, Zoe, Sage, Claire, Frihagen, Frede, Clarke-Jenssen, John, Hjorthaug, Geir, Ianssen, Torben, Khan, Ryan M., Amundsen, Asgeir, Brattgjerd, Jan Egil, Borch, Tor, Boe, Berthe, Flatoy, Bernhard, Hasselund, Sondre, Haug, Knut Jorgen, Hemlock, Kim, Hoseth, Tor Magne, Jomaas, Geir, Hidy, Jennifer T., Kibsgard, Thomas, Lona, Tarjei, Moatshe, Gilbert, Muller, Oliver, Molund, Marius, Nicolaisen, Tor, Nilsen, Fredrik, Rydinge, Jonas, Smedsrud, Morten, Stodle, Are, Coles, Chad, Trommer, Axel, Ugland, Stein, Karlsten, Anders, Ekas, Guri, Vesterhus, Elise Berg, Brekke, Anne Christine, Gupta, Ajay, Jain, Neeraj, Khan, Farah, Sharma, Ateet, Leighton, Ross, Sanghavi, Amir, Trivedi, Mittal, Rai, Anil, Subash, Rai, Kamal, Yadav, Vineet, Singh, Sanjay, Tetsworth, Kevin, Donald, Geoff, Biddulph, Michael, Weinrauch, Patrick, Pincus, Paul, Yang, Steven, Halliday, Brett, Gervais, Trevor, Holt, Michael, Flynn, Annette, Prasad, Amal Shankar, Mishra, Vimlesh, Sundaresh, D. C., Johnston, David, Khanna, Angshuman, Cherian, Joe Joseph, Olakkengil, Davy J., Sharma, Gaurav, Pirpiris, Marinis, Love, David, Bucknill, Andrew, Farrugia, Richard J., Pape, Hans-Christoph, Knobe, Matthias, Glazebrook, Mark, Pfeifer, Roman, Hull, Peter, Lewis, Sophie, Evans, Simone, Nanda, Rajesh, Logishetty, Rajanikanth, Anand, Sanjeev, Bowler, Carol, Dadi, Akhil, Palla, Naveen, Alexander, David, Ganguly, Utsav, Rai, B. Sachidananda, Rajakumar, Janakiraman, Jennings, Andrew, Chuter, Graham, Rose, Glynis, Horner, Gillian, Clark, Callum, Eke, Kate, Reed, Mike, Coady, Cathy, Herriott, Chris, Dobb, Christine, Bhandari, Mohit, Swiontkowski, Marc, Devereaux, Pj, Jeray, Kyle, Thabane, Lehana, Stone, Trevor, Dunbar, Michael, Walter, Stephen, Sprague, Sheila, Scott, Taryn, Guyatt, Gordon, Amirault, David, Viveiros, Helena, McKay, Paula, Swinton, Marilyn, Gross, Michael, Truong, Victoria, Koo, Kaitlin, Heels-Ansdell, Diane, Zhou, Qi, Buckingham, Lisa, Duraikannan, Aravin, Maddock, Deborah, Simunovic, Nicole, Agel, Julie, Oxner, William, Van Lieshout, Esther M. M., Zielinski, Stephanie M., Rangan, Amar, Hanusch, Birgit C., Kottam, Lucksy, Clarkson, Rachel, Reardon, Gerald, Slobogean, Gerard, Katz, Jeffrey, Gillespie, Brenda, Greendale, Gail A., Guy, Pierre, Hartman, Curtis, Rubin, Craig, Waddell, James, FAITH Investigators, Richardson, Glen, Trenholm, Andrew, Wong, Ivan, Trask, Kelly, MacDonald, Shelley, Viskontas, Darius, Dobbin, Gwen, Bicknell, Ryan, Yach, Jeff, Bardana, Davide, Wood, Gavin, Harrison, Mark, Yen, David, Lambert, Sue, Howells, Fiona, Ward, Angela, Lemke, H. Michael, Zalzal, Paul, Brien, Heather, Naumetz, V., Weening, Brad, Wai, Eugene K., Papp, Steve, Gofton, Wade T., Liew, Allen, Kingwell, Stephen P., Zomar, Mauri, Johnson, Garth, O'Neil, Joseph, Roffey, Darren M., Borsella, Vivian, Avram, Victoria, Oliver, Todd M., Jones, Vicki, Jones, Clifford B., Ringler, James R., Endres, Terrence J., Moon, Karyn, Sietsema, Debra L., Jeray, Kyle J., Broderick, J. Scott, Goetz, David R., Pace, Thomas B., Schaller, Thomas M., Porter, Scott E., Tanner, Stephanie L., Snider, Rebecca G., Nastoff, Lauren A., Surgery, Emergency Medicine, Obstetrics and Gynaecology, Other Research, Other departments, Graduate School, and AMS - Amsterdam Movement Sciences

Subjects
Time Factors, Sports medicine, medicine.medical_treatment, Bone Screws, Dentistry, Femoral Neck Fractures, law.invention, Fracture Fixation, Internal, Study Protocol, Postoperative Complications, 0302 clinical medicine, Clinical Protocols, Randomized controlled trial, law, Fracture fixation, Orthopedics and Sports Medicine, 030212 general & internal medicine, GeneralLiterature_REFERENCE(e.g.,dictionaries,encyclopedias,glossaries), Likelihood Functions, 030222 orthopedics, Femoral neck fractures, 3. Good health, Europe, Reconstructive and regenerative medicine Radboud Institute for Molecular Life Sciences [Radboudumc 10], Treatment Outcome, Research Design, Hip fractures, Sliding hip screw, Reoperation, medicine.medical_specialty, Asia, Prosthesis Design, 03 medical and health sciences, Fixation (surgical), Rheumatology, medicine, Humans, Internal fixation, Proportional Hazards Models, business.industry, Australia, Arthroplasty, Surgery, Reconstructive and regenerative medicine Radboud Institute for Health Sciences [Radboudumc 10], North America, Orthopedic surgery, Quality of Life, Cancellous screws, business
Abstract

Hip fractures are a common type of fragility fracture that afflict 293,000 Americans (over 5,000 per week) and 35,000 Canadians (over 670 per week) annually. Despite the large population impact the optimal fixation technique for low energy femoral neck fractures remains controversial. The primary objective of the FAITH study is to assess the impact of cancellous screw fixation versus sliding hip screws on rates of revision surgery at 24 months in individuals with femoral neck fractures. The secondary objective is to determine the impact on health-related quality of life, functional outcomes, health state utilities, fracture healing, mortality and fracture-related adverse events. FAITH is a multi-centre, multi-national randomized controlled trial utilizing minimization to determine patient allocation. Surgeons in North America, Europe, Australia, and Asia will recruit a total of at least 1,000 patients with low-energy femoral neck fractures. Using central randomization, patients will be allocated to receive surgical treatment with cancellous screws or a sliding hip screw. Patient outcomes will be assessed at one week (baseline), 10 weeks, 6, 12, 18, and 24 months post initial fixation. We will independently adjudicate revision surgery and complications within 24 months of the initial fixation. Outcome analysis will be performed using a Cox proportional hazards model and likelihood ratio test. This study represents major international efforts to definitively resolve the treatment of low-energy femoral neck fractures. This trial will not only change current Orthopaedic practice, but will also set a benchmark for the conduct of future Orthopaedic trials. The FAITH trial is registered at ClinicalTrials.gov (Identifier NCT00761813 ).

Published
2014
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