Browsing by Author "O'Hara, Nathan N."

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    Fixation Using Alternative Implants for the Treatment of Hip Fractures (FAITH-2): The Clinical Outcomes of a Multicenter 2 × 2 Factorial Randomized Controlled Pilot Trial in Young Femoral Neck Fracture Patients
    (Wolters Kluwer, 2020-10) Slobogean, Gerard P.; Sprague, Sheila; Bzovsky, Sofia; Scott, Taryn; Thabane, Lehana; Heels-Ansdell, Diane; O'Toole, Robert V.; Howe, Andrea; Gaski, Greg E.; Hill, Lauren C.; Brown, Krista M.; Viskontas, Darius; Zomar, Mauri; Della Rocca, Gregory J.; O'Hara, Nathan N.; Bhandari, Mohit; Orthopaedic Surgery, School of Medicine
    Objective: To assess whether the fixation method and vitamin D supplementation affect the risk of patient-important outcomes within 12 months of injury in nongeriatric femoral neck fracture patients. Design: A pilot factorial randomized controlled trial. Setting: Fifteen North American clinical sites. Participants: Ninety-one adults 18–60 years of age with a femoral neck fracture requiring surgical fixation. Intervention: Participants were randomized to a surgical intervention (sliding hip screw or cancellous screws) and a vitamin D intervention (vitamin D3 4000 IU daily vs. placebo for 6 months). Main Outcome Measurements: The primary clinical outcome was a composite of patient-important complications (reoperation, femoral head osteonecrosis, severe femoral neck malunion, and nonunion). Secondary outcomes included fracture-healing complications and radiographic fracture healing. Results: Eighty-six participants with a mean age of 41 years were included. We found no statistically significant difference in the risk of patient-important outcomes between the surgical treatment arms (hazard ratio 0.90, 95% confidence interval 0.40–2.02, P = 0.80) and vitamin D supplementation treatment arms (hazard ratio 0.96, 95% confidence interval 0.42–2.18, P = 0.92). Conclusions: These pilot trial results continue to describe the results of current fixation implants, inform the challenges of improving outcomes in this fracture population, and may guide future vitamin D trials to improve healing outcomes in young fracture populations. Although the pilot trial was not adequately powered to detect treatment effects, publishing these results may facilitate future meta-analyses on this topic. Level of Evidence: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.
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    Fixation using Alternative Implants for the Treatment of Hip Fractures (FAITH-2): The Exploratory Health-Related Quality of Life and Patient-Reported Functional Outcomes of a Multi-Centre 2 × 2 Factorial Randomized Controlled Pilot Trial in Young Femoral Neck Fracture Patients
    (Elsevier, 2021) Slobogean, Gerard P.; Sprague, Sheila; Bzovsky, Sofia; Scott, Taryn; Thabane, Lehana; Heels-Ansdell, Diane; O'Toole, Robert V.; Howe, Andrea; Gaski, Greg E.; Hill, Lauren C.; Brown, Krista M.; Viskontas, Darius; Zomar, Mauri; Della Rocca, Gregory J.; O'Hara, Nathan N.; Bhandari, Mohit; FAITH-2 Investigators; Orthopaedic Surgery, School of Medicine
    Purpose: Femoral neck fractures in young patients are typically managed with internal fixation using either cancellous screws or a sliding hip screw (SHS). Although fixation preserves the hip joint, patients are still at risk of complications and poor clinical outcomes which lead to diminished function and health related quality of life (HRQL). The Fixation using Alternative Implants for the Treatment of Hip Fractures (FAITH-2) pilot randomized controlled factorial trial evaluated the effect of surgical fixation (cancellous screws vs. SHS) and vitamin D supplementation vs. placebo on patient-reported function and HRQL. Methods: Patients between the ages of 18-60 years with a femoral neck fracture requiring surgical fixation were eligible. Eligible patients were randomized to receive either a sliding hip screw or cancellous screws for fracture fixation AND vitamin D3 4,000 IU or placebo daily for 6 months. Patient-reported function (Hip Outcome Score) and HRQL (Short Form-12) were assessed at standardized time points in the 12 months following their fixation surgery. Patient-reported function and HRQL were summarized using means, SD, and 95% confidence intervals (CIs), or percentages and counts. Longitudinal data analysis with mixed models was used to explore the effect of treatment group and time on the patient-reported function and HRQL. Results: 86 of the 91 patients randomized into the FAITH-2 pilot study were deemed eligible. There were no significant differences in patient-reported function or HRQL between the treatment groups at 12 months post-fracture. At the 6- and 9-month assessments, a potential benefit in hip function was seen in the cancellous screw group. In all treatment groups, participants reported lower function and HRQL at 12 months post-fracture as compared to their pre-injury assessment. Conclusions: Few differences were found in function and HRQL among the treatment groups in the FAITH-2 pilot study. Despite modern implants and vitamin D supplementation, neither function nor HRQL returns to baseline in this population. Additional efforts to improve the outcomes of these challenging injuries are still needed.
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    Patient and stakeholder engagement learnings: PREP-IT as a case study
    (Future Medicine, 2021-04) Medeiros, Michelle; Love, T Rosie; Slobogean, Gerard P.; Sprague, Sheila; Perfetto, Eleanor M.; O'Hara, Nathan N.; Mullins, C. Daniel; Slobogean, Gerard P.; Sprague, Sheila; Wells, Jeffrey; Bhandari, Mohit; D'alleyrand, Jean-Claude; Harris, Anthony; Mullins, Daniel C.; Thabane, Lehana; Wood, Amber; Della Rocca, Gregory J.; Hebden, Joan; Jeray, Kyle J.; Marchand, Lucas; O'Hara, Lyndsay M.; Zura, Robert; Gardner, Michael J.; Blasman, Jenna; Davies, Jonah; Liang, Stephen; Taljaard, Monica; Devereaux, Pj; Guyatt, Gordon H.; Heels-Ansdell, Dianne; Marvel, Debra; Palmer, Jana; Friedrich, Jeff; O'Hara, Nathan; Grissom, Frances; Gitajn, Leah; Morshed, Saam; O'Toole, Robert; Petrisor, Bradley A.; Camara, Megan; Mossuto, Franca; Joshi, Manjari G.; Fowler, Justin; Rivera, Jessica; Talbot, Max; Dodds, Shannon; Garibaldi, Alisha; Li, Silvia; Nguyen, Uyen; Pogorzelski, David; Rojas, Alejandra; Scott, Taryn; Del Fabbro, Gina; Szasz, Olivia Page; McKay, Paula; Howe, Andrea; Rudnicki, Joshua; Demyanovich, Haley; Little, Kelly; Medeiros, Michellic; Kettering, Eric; Hale, Diamond; Polk, Genevieve; Mahal, Nirmen; Eglseder, Andrew; Johnson, Aaron; Langhammer, Christopher; Lebrun, Christopher; Manson, Theodore; Nascone, Jason; Paryavi, Ebrahim; Pensy, Raymond; Pollack, Andrew; Sciadini, Marcus; Degani, Yasmin; Joseph, Katherine; Natoli, Roman M.; Gaski, Greg E.; McKinley, Todd O.; Virkus, Walter W.; Sorkin, Anthony T.; Szatkowski, Jan P.; Baele, Joseph R.; Mullis, Brian H.; Hill, Lauren C.; Hudgins, Andrea; Osborn, Patrick; Fowler, Justin; Pierrie, Sarah; Martinez, Eric; Kimmel, Joseph; Adams, John D.; Beckish, Michael; Bray, Christopher; Brown, Timothy R.; Cross, Andrew W.; Dew, Timothy; Faucher, Gregory; Gurich Jr, Richard W.; Lazarus, David E.; Millon, S. John; Palmer, M. Jason; Porter, Scott E.; Schaller, Thomas M.; Sridhar, Michael S.; Sanders, John L.; Rudisill Jr, L. Edwin; Garitty, Michael J.; Poole, Andrew S.; Sims, Michael L.; Walker, Clark M.; Carlisle II, Robert M.; Hofer, Erin Adams; Huggins, Brandon S.; Hunter, Michael D.; Marshall, William A.; Ray, Shea Bielby; Smith, Cory D.; Altman, Kyle M.; Bedard, Julia C.; Loeffler, Markus F.; Pichiotino, Erin R.; Cole, Austin A.; Maltz, Ethan J.; Parker, Wesley; Ramsey, T. Bennett; Burnikel, Alex; Colello, Michael; Stewart, Russell; Wise, Jeremy; Moody, M. Christian; Tanner, Stephanie L.; Snider, Rebecca G.; Townsend, Christine E.; Pham, Kayla H.; Martin, Abigail; Robertson, Emily; Miclau, Theodore; Kandemir, Utku; Marmor, Meir; Matityahu, Amir; McClellan, R. Trigg; Meinberg, Eric; Shearer, David; Toogood, Paul; Ding, Anthony; Donohue, Erin; Belaye, Tigist; Berhaneselase, Eleni; Paul, Alexandra; Garg, Kartik; Gary, Joshua L.; Warner, Stephen J.; Munz, John W.; Choo, Andrew M.; Achor, Timothy; Routt, Milton L. "Chip"; Rao, Mayank; Pechero, Guillermo; Miller, Adam; Hagen, Jennifer E.; Patrick, Matthew; Vlasak, Richard; Krupko, Thomas; Sadasivan, Kalia; Koenig, Chris; Bailey, Daniel; Wentworth, Daniel; Van, Chi; Schwartz, Justin; Dehghan, Niloofar; Jones, Clifford B.; Watson, J. Tracy; McKee, Michael; Karim, Ammar; Talerico, Michael; Sietsema, Debra L.; William, Alyse; Dykes, Tayler; Obremskey, William T.; Jahangir, Amir Alex; Sethi, Manish; Boyce, Robert; Stinner, Daniel J.; Mitchell, Phillip; Trochez, Karen; Rodriguez, Andres; Gajari, Vamshi; Rodriguez, Elsa; Pritchett, Chris; Boulton, Christina; Lowe, Jason; Wild, Jason; Ruth, John T.; Taylor, Michel; Seach, Andrea; Saeed, Sabina; Culbert, Hunter; Crus, Alejandro; Knapp, Thomas; Hurkett, Colin; Lowney, Maya; Prayson, Michael; Venkatarayappa, Indresh; Horne, Brandon; Jerele, Jennifer; Clark, Linda; Marcano-Fernández, Francesc; Jornet-Gibert, Montsant; Martínez-Carreres, Laia; Martí-Garín, David; Serrano-Sanz, Jorge; Sánchez-Fernández, Joel; Sanz-Molero, Matsuyama; Carballo, Alejandro; Pelfort, Xavier; Acerboni-Flores, Francesc; Alavedra-Massana, Anna; Anglada-Torres, Neus; Berenguer, Alexandre; Cámara-Cabrera, Jaume; Caparros-García, Ariadna; Fillat-Gomà, Ferran; Fuentes-López, Ruben; Garcia-Rodriguez, Ramona; Gimeno-Clavia, Nuria; Graells-Alonso, Guillem; Martínez-álvarez, Marta; Martínez-Grau, Patricia; Pellejero-García, Raúl; Ràfols-Perramon, Ona; Peñalver, Juan Manuel; Salomò Domènech, Mònica; Soler-Cano, Albert; Velasco-Barrera, Aldo; Yela-Verdú, Christian; Bueno-Ruiz, Mercedes; Sánchez-Palomino, Estrella; Guerra-Farfán, Ernesto; García, Yaiza; Romeo, Nicholas M.; Vallier, Heather A.; Breslin, Mary A.; Fraifogl, Joanne; Wilson, Eleanor S.; Wadenpfuhl, Leanne K; Halliday, Paul G.; Viskontas, Darius G.; Apostle, Kelly L.; Boyer, Dory S.; Moola, Farhad O.; Perey, Bertrand H.; Stone, Trevor B.; Lemke, H. Michael; Zomar, Mauri; Spicer, Ella; Fan, Chen "Brenda"; Payne, Kyrsten; Phelps, Kevin; Bosse, Michael; Karunakar, Madhav; Kempton, Laurence; Sims, Stephen; Hsu, Joseph; Seymour, Rachel; Churchill, Christine; Bartel, Claire; Mayberry, Robert Miles; Brownrigg, Maggie; Girardi, Cara; Mayfield, Ada; Hymes, Robert A.; Schwartzbach, Cary C.; Schulman, Jeff E.; Malekzadeh, A. Stephen; Holzman, Michael A.; Ramsey, Lolita; Ahn, James S.; Panjshiri, Farhanaz; Das, Sharmistha; English, Antoinisha D.; Haaser, Sharon M.; Cuff, Jaslynn A.N.; Pilson, Holly; Carroll, Eben A.; Halvorson, Jason J.; Babcock, Sharon; Goodman, J. Brett; Holden, Martha B.; Bullard, Debra; Williams, Wendy; Higgins, Thomas F.; Haller, Justin M.; Rothberg, David L.; Neese, Ashley; Russell, Mark; Coe, Marcus; Dwyer, Kevin; Mullin, Devin S.; Reily, Clifford A; DePalo, Peter; Hall, Amy E.; Heng, Marilyn; Harris, Mitchel B.; Smith, R. Malcolm; Lhowe, David W.; Esposito, John; Bansal, Mira; Bergin, Patrick F.; Russell, George V.; Graves, Matthew L.; Morellato, John; Champion, Heather K.; Johnson, Leslie N.; McGee, Skeketha L.; Bhanat, Eldrin L.; Mehta, Samir; Donegan, Derek; Ahn, Jaimo; Horan, Annamarie; Dooley, Mary; Kuczinski, Ashley; Iwu, Ashley; Potter, David; VanDemark II, Robert; Pfaff, Branden; Hollinsworth, Troy; Weaver, Michael J.; von Keudel, Arvind G.; McTague, Michael F.; Allen, Elizabeth M.; Jaeblon, Todd; Beer, Robert; Gage, Mark J.; Reilly, Rachel M.; Sparrow, Cindy; Paniagua, Ariana; Orthopaedic Surgery, School of Medicine