Fixation using alternative implants for the treatment of hip fractures (FAITH-2): design and rationale for a pilot multi-centre 2 × 2 factorial randomized controlled trial in young femoral neck fracture patients

FAITH-2 Investigators, Gerard P Slobogean, Sheila Sprague, Sofia Bzovsky, Diane Heels-Ansdell, Lehana Thabane, Taryn Scott, Mohit Bhandari, Gerard P Slobogean, Sheila Sprague, Sofia Bzovsky, Diane Heels-Ansdell, Lehana Thabane, Taryn Scott, Mohit Bhandari, Earl Bogoch, P J Devereaux, Gordon Guyatt, Martin J Heetveld, Kyle Jeray, Susan Liew, Robert V O'Toole, Andrew N Pollak, Emil H Schemitsch, Marc Swiontkowski, Dale Williams, Kim Madden, Alisha Garibaldi, Lisa Buckingham, Nicole Simunovic, Martí Bernaus, Eleanor M Pullenayegum, Matthew Menon, David Teague, Gregory J Della Rocca, Richard J Jenkinson, Hans J Kreder, David J G Stephen, Markku Nousiainen, Diane Nam, Patrick Henry, John Iazzetta, Katrina Hatzifilalithis, Katrine Milner, Monica Kunz, Aimee Theriault, Wesley Ghent, Araby Sivananthan, Fathima Adamsahib, Danyella Dias, Abeer Wasim, Ravianne Tuazon, Katerina Polihronidis, Aaron Nauth, Michael D McKee, Jeremy A Hall, Daniel Whelan, Timothy Daniels, Sarah Ward, Henry Ahn, James Waddell, David Walmsley, Amit Atrey, Laura Parsons, Ann Dowbenka, Gitana Ramonas, Milena R Vicente, Jennifer T Hidy, Paril Suthar, Melanie MacNevin, Darius Viskontas, Robert McCormack, Farhad Moola, Bertrand Perey, Trevor Stone, Kelly Apostle, Dory Boyer, H Michael Lemke, Mauri Zomar, Karyn Moon, Raely Pritchard, Brenda Chen Fan, Bindu Mohan, Pierre Guy, Kelly Lefaivre, Peter O'Brien, Henry Broekhuyse, Piotr Blachut, Dean Malish, Jeffrey Potter, Raman Johal, Irene Leung, Benita Okocha, Jessica Peattie, Abdullah Mamun, Steven Papp, Wade Gofton, Allan Liew, Sherry Weir, Darren M Roffey, Nicole Harris, Julia Foxall, Andrew Furey, Keegan Au, Daniel Squire, Peter Rockwood, Ashley Buck, Karen Ryan, Garrett Wells, Zeta Hannaford, Valisha Keough, Erin Baker, Sarah Anthony, Mark Richardson, Thomas DiPasquale, Paul Muccino, Troy Caron, Adrienne Brandon, Krystal Swasey, Tara Moore, David Hubbard, John France, Michelle A Bramer, Brock Lindsey, Benjamin Frye, Matthew Dietz, Adam Klein, George K Bal, E Barry McDonough, John P Lubicky, Scott Daffner, T Ryan Murphy, Lisa Giblin Sutton, Sheila Rye, Nina Clovis, Sherri Davis, Robert A Hymes, Cary C Schwartzbach, A Stephen Malekzadeh, Jeff E Schulman, Michael Holzman, Anastasia Lialios-Ramfos, Lolita Ramsey, Sharon Haaser, Gudrun Mirick Mueller, David Templeman, Andrew Schmidt, Tzivia Leviton, Jerald R Westberg, Saam Morshed, Eric Meinberg, Paul Toogood, David Shearer, Murat Pekmezci, Paul Knaus, Sara McFarland, Tigist Belaye, Eleni Berhaneselase, Johnathan Kwong, Christina Boulton, Christopher LeBrun, Jason W Nascone, Marcus F Sciadini, Raymond Pensy, Theodore Manson, W Andrew Eglseder Jr, Andrea L Howe, Daniel Connelly, Katherine Ordonio, Raza Zaidi, Yasmin Degani, Merryjessica Fuerst, Carrie Schoonover, George Reahl, Peter Berger, Ryan Montalvo, Dimitrius Marinos, Daniel Mascarenhas, Joshua Rudnicki, Clifford B Jones, Sarim Ahmed, Norman Chutkan, Michael Lucero, Jason Lowe, Russell Meldrum, Niloofar Dehghan, Ryan DiGiovanni, Pierce Johnson, Sean Karr, Sean Mitchell, Robert Walker, Debra L Sietsema, Cyndi Ventry, Susan Mauro, Karen Walsh, Bonnie Sumner, Taylor Dykes, Michael Duran, Blake Eyberg, Joseph Walker, Collin Barber, Jessica Burns, Jill Goodwin, Ryan Shelhamer, Joshua Hustedt, Damien Richardson, Julie Robbins, Greg E Gaski, Todd O McKinley, Walter W Virkus, Laurence B Kempton, Anthony T Sorkin, Roman Natoli, Charles Lieder, Landon Fine, Lauren C Hill, Krista M Brown, Lakye Deeter, Jennifer Hagen, André Spiguel, Kalia Sadasivan, Matthew Patrick, Melissa Johnson, Susan Beltz, Elizabeth Agustin, Chris Koenig, Sonya Brisbane, Tudor V Tufescu, Nigar Sultana, Ryan Bicknell, Heather Grant, Fiona Howells, Todd M Oliver, Michelle Vogt, Vicki Jones, Tina Carter, Edward Westrick, Traci Salopek, Aaron Perdue, Joel J Gagnier, James Goulet, Mark Hake, Jaimee Gauthier, Christopher Robbins, Jianyu Lai, Anne Mak, Zoe Murdoch, FAITH-2 Investigators, Gerard P Slobogean, Sheila Sprague, Sofia Bzovsky, Diane Heels-Ansdell, Lehana Thabane, Taryn Scott, Mohit Bhandari, Gerard P Slobogean, Sheila Sprague, Sofia Bzovsky, Diane Heels-Ansdell, Lehana Thabane, Taryn Scott, Mohit Bhandari, Earl Bogoch, P J Devereaux, Gordon Guyatt, Martin J Heetveld, Kyle Jeray, Susan Liew, Robert V O'Toole, Andrew N Pollak, Emil H Schemitsch, Marc Swiontkowski, Dale Williams, Kim Madden, Alisha Garibaldi, Lisa Buckingham, Nicole Simunovic, Martí Bernaus, Eleanor M Pullenayegum, Matthew Menon, David Teague, Gregory J Della Rocca, Richard J Jenkinson, Hans J Kreder, David J G Stephen, Markku Nousiainen, Diane Nam, Patrick Henry, John Iazzetta, Katrina Hatzifilalithis, Katrine Milner, Monica Kunz, Aimee Theriault, Wesley Ghent, Araby Sivananthan, Fathima Adamsahib, Danyella Dias, Abeer Wasim, Ravianne Tuazon, Katerina Polihronidis, Aaron Nauth, Michael D McKee, Jeremy A Hall, Daniel Whelan, Timothy Daniels, Sarah Ward, Henry Ahn, James Waddell, David Walmsley, Amit Atrey, Laura Parsons, Ann Dowbenka, Gitana Ramonas, Milena R Vicente, Jennifer T Hidy, Paril Suthar, Melanie MacNevin, Darius Viskontas, Robert McCormack, Farhad Moola, Bertrand Perey, Trevor Stone, Kelly Apostle, Dory Boyer, H Michael Lemke, Mauri Zomar, Karyn Moon, Raely Pritchard, Brenda Chen Fan, Bindu Mohan, Pierre Guy, Kelly Lefaivre, Peter O'Brien, Henry Broekhuyse, Piotr Blachut, Dean Malish, Jeffrey Potter, Raman Johal, Irene Leung, Benita Okocha, Jessica Peattie, Abdullah Mamun, Steven Papp, Wade Gofton, Allan Liew, Sherry Weir, Darren M Roffey, Nicole Harris, Julia Foxall, Andrew Furey, Keegan Au, Daniel Squire, Peter Rockwood, Ashley Buck, Karen Ryan, Garrett Wells, Zeta Hannaford, Valisha Keough, Erin Baker, Sarah Anthony, Mark Richardson, Thomas DiPasquale, Paul Muccino, Troy Caron, Adrienne Brandon, Krystal Swasey, Tara Moore, David Hubbard, John France, Michelle A Bramer, Brock Lindsey, Benjamin Frye, Matthew Dietz, Adam Klein, George K Bal, E Barry McDonough, John P Lubicky, Scott Daffner, T Ryan Murphy, Lisa Giblin Sutton, Sheila Rye, Nina Clovis, Sherri Davis, Robert A Hymes, Cary C Schwartzbach, A Stephen Malekzadeh, Jeff E Schulman, Michael Holzman, Anastasia Lialios-Ramfos, Lolita Ramsey, Sharon Haaser, Gudrun Mirick Mueller, David Templeman, Andrew Schmidt, Tzivia Leviton, Jerald R Westberg, Saam Morshed, Eric Meinberg, Paul Toogood, David Shearer, Murat Pekmezci, Paul Knaus, Sara McFarland, Tigist Belaye, Eleni Berhaneselase, Johnathan Kwong, Christina Boulton, Christopher LeBrun, Jason W Nascone, Marcus F Sciadini, Raymond Pensy, Theodore Manson, W Andrew Eglseder Jr, Andrea L Howe, Daniel Connelly, Katherine Ordonio, Raza Zaidi, Yasmin Degani, Merryjessica Fuerst, Carrie Schoonover, George Reahl, Peter Berger, Ryan Montalvo, Dimitrius Marinos, Daniel Mascarenhas, Joshua Rudnicki, Clifford B Jones, Sarim Ahmed, Norman Chutkan, Michael Lucero, Jason Lowe, Russell Meldrum, Niloofar Dehghan, Ryan DiGiovanni, Pierce Johnson, Sean Karr, Sean Mitchell, Robert Walker, Debra L Sietsema, Cyndi Ventry, Susan Mauro, Karen Walsh, Bonnie Sumner, Taylor Dykes, Michael Duran, Blake Eyberg, Joseph Walker, Collin Barber, Jessica Burns, Jill Goodwin, Ryan Shelhamer, Joshua Hustedt, Damien Richardson, Julie Robbins, Greg E Gaski, Todd O McKinley, Walter W Virkus, Laurence B Kempton, Anthony T Sorkin, Roman Natoli, Charles Lieder, Landon Fine, Lauren C Hill, Krista M Brown, Lakye Deeter, Jennifer Hagen, André Spiguel, Kalia Sadasivan, Matthew Patrick, Melissa Johnson, Susan Beltz, Elizabeth Agustin, Chris Koenig, Sonya Brisbane, Tudor V Tufescu, Nigar Sultana, Ryan Bicknell, Heather Grant, Fiona Howells, Todd M Oliver, Michelle Vogt, Vicki Jones, Tina Carter, Edward Westrick, Traci Salopek, Aaron Perdue, Joel J Gagnier, James Goulet, Mark Hake, Jaimee Gauthier, Christopher Robbins, Jianyu Lai, Anne Mak, Zoe Murdoch

Abstract

Background: Femoral neck fractures in patients ≤ 60 years of age are often very different injuries compared to low-energy, hip fractures in elderly patients and are difficult to manage because of inherent problems associated with high-energy trauma mechanisms and increased functional demands for recovery. Internal fixation, with multiple cancellous screws or a sliding hip screw (SHS), is the most common treatment for this injury in young patients. However, there is no clinical consensus regarding which surgical technique is optimal. Additionally, there is compelling rationale to use vitamin D supplementation to nutritionally optimize bone healing in young patients. This pilot trial will determine feasibility and provide preliminary clinical data for a larger definitive trial.

Methods: We will conduct a multicenter, concealed randomized controlled pilot study, using a 2 × 2 factorial design in 60 patients aged 18-60 years with a femoral neck fracture. Eligible patients will be randomized in equal proportions to one of four groups: 1) SHS and vitamin D supplementation (4000 international units (IU) daily dose) for 6 months, 2) cancellous screws and vitamin D supplementation (4000 IU daily dose) for 6 months, 3) SHS and placebo, and 4) cancellous screws and placebo. Participants will be followed for 12 months post-fracture. Feasibility outcomes include initiation of clinical sites, recruitment, follow-up, data quality, and protocol adherence. Clinical outcomes, for both the pilot and planned definitive trials, include a composite of patient-important outcomes (re-operation, femoral head osteonecrosis, severe femoral neck malunion, and nonunion), health-related quality of life and patient-reported function, fracture healing complications, and radiographic fracture healing. A priori success criteria have been established. If the pilot study is deemed successful, study participants will be included in the definitive trial and clinical outcomes for the pilot will not be analyzed. If the pilot study is not deemed successful, clinical outcome data will be analyzed.

Discussion: Results of this study will inform the feasibility of a definitive trial. If clinical outcome data are analyzed, they will be disseminated through a publication and presentations.

Trial registration: The FAITH-2 trial, described as a definitive trial, was registered at ClinicalTrials.gov (NCT01908751) prior to enrollment of the first participant.

Keywords: Clinical protocols; Femoral neck fractures; Fracture fixation, internal; Randomized controlled trial; Vitamin D.

Conflict of interest statement

Competing interestsThe authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Multiple cancellous screws
Fig. 2
Fig. 2
Sliding hip screw

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