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

Published
2017
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2. sj-pdf-1-ajs-10.1177_03635465231180323 – Supplemental material for Efficacy and Safety of Stempeucel in Osteoarthritis of the Knee

Author

Gupta, Pawan Kumar, Maheshwari, Sunil, Cherian, Joe Joseph, Goni, Vijay, Sharma, Arun Kumar, Tripathy, Sujith Kumar, Talari, Keerthi, Pandey, Vivek, Sancheti, Parag Kantilal, Singh, Saurabh, Bandyopadhyay, Syamasis, Shetty, Naresh, Kamath, Surendra Umesh, Prahaldbhai, Purohit Sharad, Abraham, Jijy, Kannan, Suresh, Bhat, Samatha, Parshuram, Shivashankar, Shahavi, Vinayaka, Sharma, Akhilesh, Verma, Nikhil N., and Kumar, Uday

Subjects
Surgery, Orthopaedics, Sports Medicine
Abstract

Supplemental material, sj-pdf-1-ajs-10.1177_03635465231180323 for Efficacy and Safety of Stempeucel in Osteoarthritis of the Knee by Pawan Kumar Gupta, Sunil Maheshwari, Joe Joseph Cherian, Vijay Goni, Arun Kumar Sharma, Sujith Kumar Tripathy, Keerthi Talari, Vivek Pandey, Parag Kantilal Sancheti, Saurabh Singh, Syamasis Bandyopadhyay, Naresh Shetty, Surendra Umesh Kamath, Purohit Sharad Prahaldbhai, Jijy Abraham, Suresh Kannan, Samatha Bhat, Shivashankar Parshuram, Vinayaka Shahavi, Akhilesh Sharma, Nikhil N. Verma and Uday Kumar in The American Journal of Sports Medicine

Published
2023
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3. Efficacy and Safety of Stempeucel in Osteoarthritis of the Knee: A Phase 3 Randomized, Double-Blind, Multicenter, Placebo-Controlled Study.

Author

Gupta, Pawan Kumar, Maheshwari, Sunil, Cherian, Joe Joseph, Goni, Vijay, Sharma, Arun Kumar, Tripathy, Sujith Kumar, Talari, Keerthi, Pandey, Vivek, Sancheti, Parag Kantilal, Singh, Saurabh, Bandyopadhyay, Syamasis, Shetty, Naresh, Kamath, Surendra Umesh, Prahaldbhai, Purohit Sharad, Abraham, Jijy, Kannan, Suresh, Bhat, Samatha, Parshuram, Shivashankar, Shahavi, Vinayaka, and Sharma, Akhilesh

Subjects
KNEE osteoarthritis, RESEARCH, STATISTICS, CONFIDENCE intervals, CELLULAR therapy, REGENERATION (Biology), MANN Whitney U Test, TREATMENT effectiveness, RANDOMIZED controlled trials, T-test (Statistics), BLIND experiment, DESCRIPTIVE statistics, ARTICULAR cartilage, DATA analysis software, BIOLOGICAL assay, DATA analysis, MESENCHYMAL stem cells, PATIENT safety
Abstract

Background: Osteoarthritis is a chronic, progressive, and degenerative condition with limited therapy options. Recently, biologic therapies have been an evolving option for the management of osteoarthritis. Purpose: To assess whether allogenic mesenchymal stromal cells (MSCs) have the potential to improve functional parameters and induce cartilage regeneration in patients with osteoarthritis. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: A total of 146 patients with grade 2 and 3 osteoarthritis were randomized to either an MSC group or placebo group with a ratio of 1:1. There were 73 patients per group who received either a single intra-articular injection of bone marrow–derived MSCs (BMMSCs; 25 million cells) or placebo, followed by 20 mg per 2 mL of hyaluronic acid under ultrasound guidance. The primary endpoint was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score. The secondary endpoints were WOMAC subscores for pain, stiffness, and physical function; the visual analog scale score for pain; and magnetic resonance imaging findings using T2 mapping and cartilage volume. Results: Overall, 65 patients from the BMMSC group and 68 patients from the placebo group completed 12-month follow-up. The BMMSC group showed significant improvements in the WOMAC total score compared with the placebo group at 6 and 12 months (percentage change: −23.64% [95% CI, −32.88 to −14.40] at 6 months and −45.60% [95% CI, −55.97 to −35.23] at 12 months P <.001; percentage change, −44.3%). BMMSCs significantly improved WOMAC pain, stiffness, and physical function subscores as well as visual analog scale scores at 6 and 12 months (P <.001). T2 mapping showed that there was no worsening of deep cartilage in the medial femorotibial compartment of the knee in the BMMSC group at 12-month follow-up, whereas in the placebo group, there was significant and gradual worsening of cartilage (P <.001). Cartilage volume did not change significantly in the BMMSC group. There were 5 adverse events that were possibly/probably related to the study drug and consisted of injection-site swelling and pain, which improved within a few days. Conclusion: In this small randomized trial, BMMSCs proved to be safe and effective for the treatment of grade 2 and 3 osteoarthritis. The intervention was simple and easy to administer, provided sustained relief of pain and stiffness, improved physical function, and prevented worsening of cartilage quality for ≥12 months. Registration: CTRI/2018/09/015785 (National Institutes of Health and Clinical Trials Registry–India). [ABSTRACT FROM AUTHOR]

Published
2023
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4. Reliability, Validity, and Responsiveness of the Western Ontario and McMaster Universities Osteoarthritis Index for Elderly Patients with a Femoral Neck Fracture

Author

Burgers, Paul T.P.W., Poolman, Rudolf W, Van Bakel, Theodorus MJ, Tuinebreijer, Wim E, Zielinski, Stephanie M, Bhandari, Mohit, Patka, Peter, Van Lieshout, Esther MM, Bhandari, Mohit, Devereaux, P J, Guyatt, Gordon H, Einhorn, Thomas A, Thabane, Lehana, Schemitsch, Emil H, Koval, Kenneth J, Frihagen, Frede, Poolman, Rudolf W, Tetsworth, Kevin, Guerra-Farfan, Ernesto, Walter, Stephen D, Sprague, Sheila, Swinton, Marilyn, Scott, Taryn, McKay, Paula, Madden, Kim, Heels-Ansdell, Diane, Buckingham, Lisa, Duraikannan, Aravin, Silva, Heather, Heetveld, Martin J, Van Lieshout, Esther MM, Burgers, Paul T.P.W., Zura, Robert D, Avram, Victoria, Manjoo, Ajay, Williams, Dale, Antoniou, John, Ramsay, Tim, Bogoch, Earl R, Trenholm, Andrew, Lyman, Stephen, Mazumdar, Madhu, Bozic, Kevin J, Luborsky, Mark, Goodman, Stuart, Muray, Susan, Korley, Rob, Buckley, Richard, Duffy, Paul, Puloski, Shannon, Carcary, Kimberly, Lorenzo, Melissa, McKee, Michael D, Hall, Jeremy A, Nauth, Aaron, Whelan, Daniel, Daniels, Timothy R, Waddell, James P, Ahn, Henry, Vicente, Milena R, Hidy, Jennifer T, MacNevin, Melanie T, Kreder, Hans, Axelrod, Terry, Jenkinson, Richard, Nousiainen, Markku, Stephen, David, Wadey, Veronica, Kunz, Monica, Milner, Katrine, Cagaanan, Ria, MacNevin, Melanie, O’Brien, Peter J, Blachut, Piotr A, Broekhuyse, Henry M, Guy, Pierre, Lefaivre, Kelly A, Slobogean, Gerard P, Johal, Raman, Leung, Irene, Coles, Chad, Leighton, Ross, Richardson, C. Glen, Biddulph, Michael, Gross, Michael, Dunbar, Michael, Amirault, J. David, Alexander, David, Coady, Catherine, Glazebrook, Mark, Johnston, David, Oxner, William, Reardon, Gerald, Wong, Ivan, Trask, Kelly, MacDonald, Shelley, Furey, Andrew, Stone, Craig, Parsons, Minnie, Stone, Trevor, Zomar, Mauri, McCormack, Robert, Apostle, Kelly, Boyer, Dory, Moola, Farhad, Perey, Bertrand, Viskontas, Darius, Moon, Karyn, Moon, Raely, Laflamme, Yves, Benoit, Benoit, Ranger, Pierre, Malo, Michel, Fernandes, Julio, Tardif, Karine, Fournier, Julie, Vendittoli, Pascal André, Massé, Vincent, Roy, Alain G, Lavigne, Martin, Lusignan, Daniel, Davis, Craig, Stull, Philip, Weinerman, Stewart, Weingarten, Peter, Lindenbaum, Steven, Hewitt, Michael, Danielwicz, Rebecca, Baker, Janell, Mont, Michael, Delanois, Donald E, Kapadia, Bhaveen, Issa, Kimona, Mullen, Marylou, Sems, Andrew, Foreman, Barb, Parvizi, Javad, Morrison, Tiffany, Lewis, Courtland, Caminiti, Stephanie, Tornetta, Paul, III, Creevy, William R, Lespasio, Michelle J, Carlisle, Hope, Marcantonio, Andrew, Kain, Michael, Specht, Lawrence, Tilzey, John, Garfi, John, Mehta, Samir, Esterhai, John L, Jr., Ahn, Jaimo, Donegan, Derek, Horan, Annamarie, McGinnis, Kelly, Roberson, James, Bradbury, Thomas, Erens, Greg, Webb, Kyle, Mullis, Brian, Shively, Karl, Parr, Andrew, Ertl, Janos, Worman, Ripley, Webster, Mark, Cummings, Judd, Frizzell, Valda, Moore, Molly, Jones, Clifford B, Ringler, James R, Sietsema, Debra L, Walker, Jane E, Kanlic, Enes, Abdelgawad, Amr, Shunia, Juan, DePaolo, Charles, Sutherland, Susan, Alosky, Rachel, Zura, Robert, Manson, Maria, Strathy, Gregg, Peter, Kathleen, Johnson, Paul, Morton, Meaghan, Shaer, James, Schrickel, Tyson, Hileman, Barbara, Hanes, Marina, Chance, Elisha, Heinrich, E. Matthew, Dodgin, David, LaBadie, Michele, Zamorano, David, Tynan, Martin, Schwarzkopf, Ran, Scolaro, John A, Gupta, Ranjan, Bederman, Samuel, Bhatia, Nitin, Hoang, Bang, Kiester, Douglas, Jones, Neil, Rafijah, Gregory, Alavekios, Damon, Lee, Jason, Mehta, Akshay, Schroder, Steven, Chao, Tom, Colin, Vincent, Dang, Phuc (Phil), Heng, Stephen Keun, Lopez, Gregory, Galle, Samuel, Pahlavan, Sohrab, Phan, Duy L, Tapadia, Minal, Bui, Christopher, Jain, Nickul, Moore, Tyler, Moroski, Nathan, Pourmand, Deeba, Kubiak, Erik N, Gililland, Jeremy, Rothberg, David, Peters, Christopher, Pelt, Christopher, Stuart, Ami R, Corbey, Kirby, Shuler, Franklin D, Day, James, Garabekyan, Tigran, Cheung, Felix, Oliashirazi, Ali, Salava, Jonathon, Morgan, Linda, Wilson-Byrne, Timothy, Cordle, Mary Beth, Elmans, Leon H.G.J., van den Hout, Joost A.A.M., Joosten, Adrianus JP, van Beurden, Ad FA, Bolder, Stefan BT, Eygendaal, Denise, Moonen, Adrianus F.C.M., van Geenen, Rutger CI, Hoebink, Eric A, Wagenmakers, Robert, van Helden, Wouter, van Jonbergen, Hans-Peter W, Roerdink, Herbert, Reuver, Joost M, Barnaart, Alexander FW, Flikweert, Elvira R, Krips, Rover, Mullers, J. Bernard, Schüller, Hans, Falke, Mark LM, Kurek, Frans J, Slingerland, Adrianus CH, van Dijk, Jan P, van Helden, Wouter H, Bolhuis, Hugo W, Bullens, Pieter HJ, Hogervorst, Mike, de Kroon, Karin E, Jansen, Rob H, Steenstra, Ferry, Raven, Eric EJ, Fontijne, W. Peter J, Wiersma, Saskia C, Boetes, Bastiaan, ten Holder, Edgar JT, van der Heide, Huub JL, Nagels, Jochem, van der Linden-van der Zwaag, Enrike H.M.J., Keizer, Stefan B, Swen, Jan-Willem A, den Hollander, Peter HC, Thomassen, Bregje JW, Molekamp, Willem Jan Kleyn, de Meulemeester, Frank R.A.J., Kleipool, Arthur EB, Haverlag, Robert, Simons, Maarten P, Mutsaerts, Eduard L.A.R., Kooijman, Rob, Postema, Roelf R, Bleker, René J.T.M., Lampe, Harald IH, Schuman, Lein, Cheung, John, van Bommel, Frank, Winia, W. Paul, Haverkamp, Daniel, van der Vis, Harm, Nolte, Peter A, van den Bekerom, Michel PJ, de Jong, Tjitte, van Noort, Arthur, Vergroesen, Diederik A, Schutte, Bernard G, van der Vis, Harm M, Beimers, Lijkele, de Vries, Jasper, Zurcher, Arthur W, Albers, G.H. Rob, Rademakers, Maarten, Breugem, Stefan, van der Haven, Ibo, Jan Damen, Pieter, Bulstra, Gythe H, Campo, Martin M, Somford, Mathijs P, Haverkamp, Daniël, Liew, Susan, Bedi, Harvinder, Carr, Ashley, Chia, Andrew, Csongvay, Steve, Donohue, Craig, Doig, Stephen, Edwards, Elton, Esser, Max, Freeman, Richard, Gong, Andrew, Li, Doug, Miller, Russell, Ton, Lu, Wang, Otis, Young, Ian, Dowrick, Adam, Murdoch, Zoe, Sage, Claire, Page, Richard, Bainbridge, David, Angliss, Richard, Miller, Ben, Thomson, Andrew, Brown, Graeme, Williams, Simon, Eng, Kevin, Bowyer, David, Skelley, John, Goyal, Chatar, Beattie, Sally, Guerado, Enrique, Cruz, Encarnacion, Cano, Juan Ramon, Froufe, Miguel Angel, Serra, Lluis Marull, Al-dirra, Samer, Martinez, Cristina, Tarazona Santabalbina, Francisco José, Serra, Jordi Teixidor, Hernandez, Jordi Tomas, Garcia, Marc Aguilar, Garcia, Vicente Molero, Barrera, Sergi, Garrido, Miriam, Nordsletten, Lars, Clarke-Jenssen, John, Hjorthaug, Geir, Brekke, Anne Christine, Vesterhus, Elise Berg, Skaugrud, Ingunn, Tripathi, Pradeep, Katiyar, Sandesh, Shukla, Preksha, Swiontkowski, Marc, Guyatt, Gordon, Jeray, Kyle, Walter, Stephen, Viveiros, Helena, Truong, Victoria, Koo, Kaitlin, Zhou, Qi, Maddock, Deborah, Simunovic, Nicole, Agel, Julie, Zielinski, Stephanie M, Rangan, Amar, Hanusch, Birgit C, Kottam, Lucksy, Clarkson, Rachel, Della Rocca, Gregory J, Slobogean, Gerard, Katz, Jeffrey, Gillespie, Brenda, Greendale, Gail A, Hartman, Curtis, Rubin, Craig, Waddell, James, Lemke, H. Michael, Oatt, Amber, Buckley, Richard E, Korley, Robert, Johnston, Kelly, Powell, James, Sanders, David, Lawendy, Abdel, Tieszer, Christina, Murnaghan, John, Nam, Diane, Yee, Albert, Whelan, Daniel B, Wild, Lisa M, Khan, Ryan M, Coady, Cathy, Amirault, David, Richardson, Glen, Dobbin, Gwen, Bicknell, Ryan, Yach, Jeff, Bardana, Davide, Wood, Gavin, Harrison, Mark, Yen, David, Lambert, Sue, Howells, Fiona, Ward, Angela, Zalzal, Paul, Brien, Heather, Naumetz, V, Weening, Brad, Wai, Eugene K, Papp, Steve, Gofton, Wade T, Kingwell, Stephen P, Johnson, Garth, O’Neil, Joseph, Roffey, Darren M, Borsella, Vivian, Oliver, Todd M, Jones, Vicki, Endres, Terrence J, Agnew, Samuel G, 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, 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, Wright, David M, Marcantonio, Andrew J, Kain, Michael SH, Iorio, Richard, Specht, Lawrence M, Tilzey, John F, Lobo, Margaret J, Garfi, John S, Vallier, Heather A, Dolenc, Andrea, Robinson, Chalitha, Prayson, Michael J, Laughlin, Richard, Rubino, L. Joseph, May, Jedediah, Rieser, Geoffrey Ryan, Dulaney-Cripe, Liz, Gayton, Chris, Gorczyca, John T, Gross, Jonathan M, Humphrey, Catherine A, Kates, Stephen, Noble, Krista, McIntyre, Allison W, Pecorella, Kaili, Davis, Craig A, Lindenbaum, Stephen, Schwappach, John, Baker, Janell K, Rutherford, Tori, Newman, Heike, Lieberman, Shane, Finn, Erin, Robbins, Kristin, Hurley, Meghan, Lyle, Lindsey, Mitchell, Khalis, Browner, Kieran, Whatley, Erica, Payton, Krystal, Reeves, Christina, Cannada, Lisa K, Karges, David, Hill, Leslie, Esterhai, John, Horan, Annamarie D, Kaminski, Christine A, Kowalski, Brynn N, Keeve, Jonathan P, Anderson, Christopher G, McDonald, Michael D, Hoffman, Jodi M, Tarkin, Ivan, Siska, Peter, Gruen, Gary, Evans, Andrew, Farrell, Dana J, Irrgang, James, Luther, Arlene, Cross, William W, III, 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, Seuffert, Patricia, Hsu, Joseph R, Ficke, James, Charlton, Michael, Napierala, Matthew, Fan, Mary, Tannoury, Chadi, Archdeacon, Michael, Finnan, Ryan, Le, Toan, Wyrick, John, Hess, Shelley, Brennan, Michael L, Probe, Robert, Kile, Evelyn, Mills, Kelli, Clipper, Lydia, Yu, Michelle, Erwin, Katie, Horwitz, Daniel, Strohecker, Kent, Swenson, Teresa K, Schmidt, Andrew H, Westberg, Jerald R, Aurang, Kamran, Zohman, Gary, Peterson, Brett, Huff, Roger B, Baele, Joseph, Weber, Timothy, Edison, Matt, McBeth, Jessica, Ertl, Janos P, Parr, J. Andrew, Moore, Molly M, Tobias, Erin, Thomas, Emily, DePaolo, Charles J, Shell, Leslie E, Hampton, Lynne, Shepard, Stephanie, Nanney, Tracy, Cuento, Claudine, Cantu, Robert V, Henderson, Eric R, Eickhoff, Linda S, Hammerberg, E. Mark, Stahel, Philip, Hak, David, Mauffrey, Cyril, Gibula, Douglas, Gissel, Hannah, Henderson, Corey, Zamorano, David P, Tynan, Martin C, Lawson, Deanna, Crist, Brett D, Murtha, Yvonne M, Anderson, Linda K, Linehan, Colleen, Pilling, Lindsey, Lewis, Courtland G, Sullivan, Raymond J, Roper, Elizabeth, Obremskey, William, Kregor, Philip, Richards, Justin E, Stringfellow, Kenya, Dohm, Michael P, Zellar, Abby, Segers, Michiel JM, Zijl, Jacco AC, Verhoeven, Bart, Smits, Anke B, de Vries, Jean Paul PM, Fioole, Bram, van der Hoeven, Henk, Theunissen, Evert BM, de Vries Reilingh, Tammo S, Govaert, Lonneke, Wittich, Philippe, de Brauw, Maurits, Wille, Jan, Go, Peter M.N.Y.M., Ritchie, Ewan D, Wessel, Ronald N, Hammacher, Eric R, Visser, Gijs A, Stockmann, Heyn, Silvis, Rob, Snellen, Jaap P, Rijbroek, Bram, Scheepers, Joris JG, Vermeulen, Erik GJ, Siroen, Michiel PC, Vuylsteke, Ronald, Brom, Hans LF, Rijna, Herman, de Rijcke, Piet AR, Koppert, Cees L, Buijk, Steven E, Groenendijk, Richard PR, Dawson, Imro, Tetteroo, Geert WM, Bruijninckx, Milko MM, Doornebosch, Pascal G, de Graaf, Eelco JR, van der Elst, Maarten, van der Pol, Carmen C, van’t Riet, Martijne, Karsten, Tom M, de Vries, Mark R, Stassen, Laurents PS, Schep, Niels WL, Ben Schmidt, G, Hoffman, W H, van der Heijden, Frank H.W.M., Willems, W. Jaap, van der Hart, Cor P, Turckan, Kahn, Festen, Sebastiaan, de Nies, Frank, Out, Nico JM, Bosma, Jan, van Kampen, Albert, Biert, Jan, van Vugt, Arie B, Edwards, Michael JR, Blokhuis, Taco J, Frölke, Jan Paul M, Geeraedts, Leo MG, Gardeniers, Jean WM, Tan, Edward T.C.H., Poelhekke, Lodewijk M.S.J., de Waal Malefijt, Maarten C, Schreurs, Bart, 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 HR, de Mol van Otterloo, Alexander, Hoogendoorn, Jochem, de Vries, Alexander C, Meylaerts, Sven AG, Verhofstad, Michiel HJ, Meijer, Joost, van Egmond, Teun, van der Brand, Igor, Patka, Peter, Eversdijk, Martin G, Peters, Rolf, Den Hartog, Dennis, Van Waes, Oscar JF, Oprel, Pim, Campo, Martin, Verhagen, Ronald, Albers, G.H. Robert, Simmermacher, Rogier KJ, van Mulken, Jeroen, van Wessem, Karlijn, van Gaalen, Steven M, Leenen, Luke PH, Bronkhorst, Maarten W.G.A., Guicherit, Onno R, Goslings, J. Carel, Ponsen, Kees Jan, Bhatia, Mahesh, Arora, Vinod, Tyagi, Vivek, Gupta, Ajay, Jain, Neeraj, Khan, Farah, Sharma, Ateet, Sanghavi, Amir, Trivedi, Mittal, Rai, Anil, Subash, Rai, Kamal, Yadav, Vineet, Singh, Sanjay, Prasad, Amal Shankar, Mishra, Vimlesh, Sundaresh, D C, Khanna, Angshuman, Cherian, Joe Joseph, Olakkengil, Davy J, Sharma, Gaurav, Dadi, Akhil, Palla, Naveen, Ganguly, Utsav, Rai, B. Sachidananda, Rajakumar, Janakiraman, Hull, Peter, Lewis, Sophie, Evans, Simone, Nanda, Rajesh, Logishetty, Rajanikanth, Anand, Sanjeev, Bowler, Carol, Jennings, Andrew, Chuter, Graham, Rose, Glynis, Horner, Gillian, Clark, Callum, Eke, Kate, Reed, Mike, Herriott, Chris, Dobb, Christine, Curry, Hamish, Etherington, Greg, Jain, Arvind, Moaveni, Ash, Russ, Matthias, Donald, Geoff, Weinrauch, Patrick, Pincus, Paul, Yang, Steven, Halliday, Brett, Gervais, Trevor, Holt, Michael, Flynn, Annette, Pirpiris, Marinis, Love, David, Bucknill, Andrew, Farrugia, Richard J, Ianssen, Torben, Amundsen, Asgeir, Brattgjerd, Jan Egil, Borch, Tor, Bøe, Berthe, Flatøy, Bernhard, Hasselund, Sondre, Haug, Knut Jørgen, Hemlock, Kim, Hoseth, Tor Magne, Jomaas, Geir, Kibsgård, Thomas, Lona, Tarjei, Moatshe, Gilbert, Müller, Oliver, Molund, Marius, Nicolaisen, Tor, Nilsen, Fredrik, Rydinge, Jonas, Smedsrud, Morten, Stødle, Are, Trommer, Axel, Ugland, Stein, Karlsten, Anders, Ekås, Guri, Pape, Hans-Christoph, Knobe, Matthias, and Pfeifer, Roman

Published
2015
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5. A Comparative Study of Bacteriological Culture Results Using Swab and Tissue in Open Fractures: A Pilot Study

Author

Cherian, Joe Joseph, Lobo, Jithin O, and Ramesh, L J

Subjects
Case Report, Open fractures, tissue culture, infection, swab culture
Abstract

Introduction: The role of perioperative cultures to identify infection in open fractures has been doubtful. The method of sampling for cultures in open fractures includes swab or tissue collection. However, the efficacy of either of these two techniques has not been compared in the setting of an acute open fracture. We conducted a study to compare the bacteriological culture results between the two techniques. Methodology: A pilot study was done at our institution, where all type 2, 3A, and 3B open fractures admitted in the emergency and operated for debridement and stabilization were included in the study. Intraoperatively, after debridement of the wound, swab and tissue specimens were collected and sent to the same laboratory. The results of the cultures were then collected for comparison after the necessary incubation period. Follow-up of outpatient records was also done to see its clinical significance. Results: A total of 30 samples of swab and tissue cultures collected post-debridement of acute open fractures in the operation theater were studied. Only 13 samples grew an organism either in swab/tissue culture or both. Nine tissue samples and eight swab samples showed growth. In four cases, both swab and tissue showed growth, but the same organism grew in only one instance. The other three cases showing growth in both tissue and swab had different organisms. Statistically, the kappa coefficient was found to be 0.26 and the agreement between swab and tissue culture was found fair. However, the kappa did not account for the species of the organisms. Tissue samples showed more number of specific organism growing in them, compared to swab culture samples. Conclusion: The ideal technique of taking samples for culture in acute open fractures is uncertain. Tissue culture may be better in isolating specific organisms in an acute open fracture wound. However, it is uncertain if the same organism may cause infection.

Published
2019

6. Case of Acute Concomitant Rupture of Anterior Cruciate Ligament and Patellar Tendon of Knee: Surgical Decision Making and Outcome

Author

Lobo, Jithin Orville, Cherian, Joe Joseph, and Sahu, Arnav

Subjects
musculoskeletal diseases, extensor mechanism, anterior cruciate ligament, Case Report, musculoskeletal system, human activities, Patellar tendon
Abstract

Introduction: Acute concomitant rupture of both anterior cruciate ligament (ACL) and patellar tendon is a rare injury. The diagnosis of either of the injuries may be missed on clinical examination in the emergency room. A high index of suspicion is necessary when active extension is absent, and necessary investigations like ultrasound or magnetic resonance imaging (MRI) should be done to confirm the diagnosis. There are no fixed treatment protocols in these injuries. The options include immediate repair of patellar tendon with either simultaneous or delayed reconstruction of ACL. Case Report: We present a case of 30-year-old man with simultaneous ACL and patellar tendon injury sustained in a RTA, riding pillion on a bike. The mechanism of injury was a direct blow on his flexed right knee followed by landing on the ground, on his foot with a twisting valgus thrust. Following clinical examination and radiographs, MRI was done which showed complete patellar tendon mid substance rupture and ACL tear. A staged procedure was planned, and the patient was taken up for immediate patellar tendon repair. This was followed by 5 weeks of cast immobilization. After 6 weeks, the knee was mobilized and ACL reconstruction was done using hamstring graft. At last, follow-up, the patient regained full knee extension and flexion up to 120° with normal gait. Conclusion: High-velocity knee injuries have to be carefully evaluated for such concomitant tears, as they may be missed. If suspected, an immediate ultrasound scan or MRI should be done to confirm the injuries, especially that of the patellar tendon. As of now, a staged procedure comprising immediate patellar tendon repair followed by ACL reconstruction at a later date seems to be the better option of treatment.

Published
2017

8. 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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9. Clinical and radiological instability following standard fenestration discectomy.

Author

Mascarenhas, Amrithlal A., Thomas, Issac, Sharma, Gaurav, and Cherian, Joe Joseph

Subjects
DISCECTOMY, INTERVERTEBRAL disk, SKELETON, PATIENTS, SURGERY
Abstract

Background: Post-surgical lumbar instability is an established complication but there is limited evidence in the literature regarding the incidence of lumbar instability following fenestration and discectomy. We analyzed our results following fenestration discectomy with a special focus on instability. Materials and Methods: Eighty-three patients between the age of 17 and 52 years who had undergone fenestration discectomy for a single-level lumbar intervertebral disc prolapse were followed-up for a period of 1-5 years. The criteria for instability included "instability catch,", "painful catch," and "apprehension." The working capacity of the patient and the outcome score of the surgery were assessed by means of the Oswestry disability score and the Prolo economic and functional outcome score. Flexion-extension lateral radiographs were taken and analyzed for abnormal tilt and translation. Results: Of the 83 patients included, 70 were men and 13 were women, with an average age of 37.35 years (17-52 years) at 5 years follow-up. Clinical instability was seen in 10 (12.04%) patients. Radiological instability was noted in 29 (34.9%) patients. Only six (60%) of the 10 patients who demonstrated clinical instability had radiological evidence of instability. Twenty (68.96%) patients with radiological instability were asymptomatic. Three (10.34%) patients with only radiological instability had unsatisfactory outcome. The Oswestry scoring showed an average score of 19.8%. Mild disability was noted in 59 (71.08%) patients and moderate disability was seen in 24 (28.91%) patients. None of the patients had severe disability. These outcomes were compared with the outcomes in other studies in the literature for microdiscectomy and the results were found to be comparable. Conclusion: The favorable outcome of this study is in good agreement with other studies on microdiscectomy. Clinical instability in 12.04% of the patients is in agreement with other studies. Radiological signs of instability are seen even in asymptomatic patients and so are not as reliable as clinical signs of instability. Standard fenestration discectomy does not destabilize the spine more than microdiscectomy. [ABSTRACT FROM AUTHOR]

Published
2009
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10. 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, Boyer, Dory, Moola, Farhad, Perey, Bertrand, Stone, Trevor, Viskontas, Darius, Lemke, H. Michael, Zomar, Mauri, Moon, Karyn, Moon, Raely, Oatt, Amber, Buckley, Richard E., Duffy, Paul, Korley, Robert, Puloski, Shannon, Johnston, Kelly, Powell, James, Carcary, Kimberly, Sanders, David, Lawendy, Abdel, Tieszer, Christina, Stephen, David, Kreder, Hans, Jenkinson, Richard, Nousiainen, Markku, Axelrod, Terry, Murnaghan, John, Nam, Diane, Wadey, Veronica, Yee, Albert, Milner, Katrine, Kunz, Monica, Schemitsch, Emil H., Ahn, Henry, Hall, Jeremy A., McKee, Michael D., Whelan, Daniel B., Nauth, Aaron, Vicente, Milena R., Wild, Lisa M., Khan, Ryan M., Hidy, Jennifer T., Coles, Chad, Leighton, Ross, Biddulph, Michael, Johnston, David, Glazebrook, Mark, Alexander, David, Coady, Cathy, Dunbar, Michael, Amirault, David, Gross, Michael, Oxner, William, Reardon, Gerald, Richardson, Glen, Trenholm, Andrew, Wong, Ivan, Trask, Kelly, MacDonald, Shelley, Dobbin, Gwen, Bicknell, Ryan, Yach, Jeff, Bardana, Davide, Wood, Gavin, Harrison, Mark, Yen, David, Lambert, Sue, Howells, Fiona, Ward, Angela, Zalzal, Paul, Brien, Heather, Naumetz, V., Weening, Brad, Simunovic, Nicole, Wai, Eugene K., Papp, Steve, Gofton, Wade T., Liew, Allen, Kingwell, Stephen P., 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., 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., 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, 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, Robinson, Chalitha, Prayson, Michael J., Laughlin, Richard, Rubino, L. Joseph, May, Jedediah, Rieser, Geoffrey Ryan, Dulaney-Cripe, Liz, Gayton, Chris, Shaer, James, Schrickel, Tyson, 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, Weingarten, Peter, Stull, Philip, Lindenbaum, Stephen, Hewitt, Michael, Schwappach, John, Baker, Janell K., Rutherford, Tori, Newman, Heike, Lieberman, Shane, Finn, Erin, Robbins, Kristin, Hurley, Meghan, Lyle, Lindsey, Mitchell, Khalis, Browner, Kieran, Whatley, Erica, Payton, Krystal, Reeves, Christina, Cannada, Lisa K., Karges, David, 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., 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., 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., Seuffert, Patricia, Hsu, Joseph R., Ficke, James, Charlton, Michael, Napierala, Matthew, Fan, Mary, Tornetta III., Paul, Tannoury, Chadi, Carlisle, Hope, Silva, Heather, Archdeacon, Michael, Finnan, Ryan, Le, Toan, Wyrick, John, Hess, Shelley, Brennan, Michael L., Probe, Robert, Kile, Evelyn, Mills, Kelli, Clipper, Lydia, Yu, Michelle, Erwin, Katie, Horwitz, Daniel, Strohecker, Kent, Swenson, Teresa K., Aurang, Kamran, Zohman, Gary, Peterson, Brett, Huff, Roger B., Baele, Joseph, Weber, Timothy, Edison, Matt, McBeth, Jessica, Shively, Karl, Ertl, Janos P., Mullis, Brian, Parr, J. Andrew, Worman, Ripley, Frizzell, Valda, Moore, Molly M., Tobias, Erin, Thomas, Emily, DePaolo, Charles J., Alosky, Rachel, Shell, Leslie E., Hampton, Lynne, Shepard, Stephanie, Nanney, Tracy, Cuento, Claudine, Cantu, Robert V., Henderson, Eric R., Eickhoff, Linda S., Hammerberg, E. Mark, Stahel, Philip, Hak, David, Mauffrey, Cyril, Gibula, Douglas, Gissel, Hannah, Henderson, Corey, Zamorano, David P., 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., 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., 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, 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, 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., 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, Karsten, Tom M., De Vries, Mark R., Stassen, Laurents P. S., Schep, Niels W. L., Ben Schmidt, G., Hoffman, W. H., Poolman, Rudolf W., Simons, Maarten P., Van Der Heijden, Frank H. W. M., Willems, W. Jaap, 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, 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, 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., 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, 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., 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, Ponsen, Kees Jan, Bhatia, Mahesh, Arora, Vinod, Tyagi, Vivek, Liew, Susan, Bedi, Harvinder, Carr, Ashley, Curry, Hamish, Chia, Andrew, Csongvay, Steve, Donohue, Craig, Doig, Stephen, Edwards, Elton, Etherington, Greg, Esser, Max, Gong, Andrew, Jain, Arvind, Li, Doug, Miller, Russell, Moaveni, Ash, Russ, Matthias, Ton, Lu, Wang, Otis, Dowrick, Adam, Murdoch, Zoe, Sage, Claire, Frihagen, Frede, Clarke-Jenssen, John, Hjorthaug, Geir, Ianssen, Torben, Amundsen, Asgeir, Brattgjerd, Jan Egil, Borch, Tor, Boe, Berthe, Flatoy, Bernhard, Hasselund, Sondre, Haug, Knut Jorgen, Hemlock, Kim, Hoseth, Tor Magne, Jomaas, Geir, Kibsgard, Thomas, Lona, Tarjei, Moatshe, Gilbert, Muller, Oliver, Molund, Marius, Nicolaisen, Tor, Nilsen, Fredrik, Rydinge, Jonas, Smedsrud, Morten, Stodle, Are, Trommer, Axel, Ugland, Stein, Karlsten, Anders, Ekas, Guri, Vesterhus, Elise Berg, Brekke, Anne Christine, Gupta, Ajay, Jain, Neeraj, Khan, Farah, Sharma, Ateet, Sanghavi, Amir, Trivedi, Mittal, Rai, Anil, Subash, Rai, Kamal, Yadav, Vineet, Singh, Sanjay, Tetsworth, Kevin, Donald, Geoff, Weinrauch, Patrick, Pincus, Paul, Yang, Steven, Halliday, Brett, Gervais, Trevor, Holt, Michael, Flynn, Annette, Prasad, Amal Shankar, Mishra, Vimlesh, Sundaresh, D. C., Khanna, Angshuman, Cherian, Joe Joseph, Olakkengil, Davy J., Sharma, Gaurav, Pirpiris, Marinis, Love, David, Bucknill, Andrew, Farrugia, Richard J., Pape, Hans-Christoph, Knobe, Matthias, Pfeifer, Roman, Hull, Peter, Lewis, Sophie, Evans, Simone, Nanda, Rajesh, Logishetty, Rajanikanth, Anand, Sanjeev, Bowler, Carol, Dadi, Akhil, Palla, Naveen, Ganguly, Utsav, Rai, B. Sachidananda, Rajakumar, Janakiraman, Jennings, Andrew, Chuter, Graham, Rose, Glynis, Horner, Gillian, Clark, Callum, Eke, Kate, Reed, Mike, Herriott, Chris, Dobb, Christine, Bhandari, Mohit, Swiontkowski, Marc, Devereaux, Pj, Jeray, Kyle, Thabane, Lehana, Walter, Stephen, Sprague, Sheila, Scott, Taryn, Guyatt, Gordon, Viveiros, Helena, McKay, Paula, Swinton, Marilyn, Truong, Victoria, Koo, Kaitlin, Heels-Ansdell, Diane, Zhou, Qi, Buckingham, Lisa, Duraikannan, Aravin, Maddock, Deborah, Agel, Julie, Van Lieshout, Esther M. M., Zielinski, Stephanie M., Rangan, Amar, Hanusch, Birgit C., Kottam, Lucksy, Clarkson, Rachel, Slobogean, Gerard, Katz, Jeffrey, Gillespie, Brenda, Greendale, Gail A., Guy, Pierre, Hartman, Curtis, Rubin, Craig, Waddell, James, and FAITH Investigators

Subjects
3. Good health
Abstract

BMC musculoskeletal disorders 15, 219 (2014). doi:10.1186/1471-2474-15-219, Published by BioMed Central, London

11. A Prospective, Active-controlled, Randomized, Double-blind, Multicenter, Phase III Study to Compare the Safety and Efficacy of Biosimilar Denosumab vs Reference Denosumab in the Treatment of Postmenopausal Osteoporosis.

Author

Paul T, Garg B, Kapoor N, Patil V, Kachnerkar N, Shembalkar J, Purohit S, Maheshwari S, Maheshwari S, Yadav A, Cherian JJ, Agrawal A, Basu K, Tripathy SK, Pongde AB, Goni V, Markade P, Makane A, Tiwaskar M, Cherian KE, Rane Y, Shahavi V, Poojary V, Somani R, Gondane A, Aiwale A, Pawar D, Pawar R, and Sharma A

Subjects
Humans, Female, Double-Blind Method, Middle Aged, Prospective Studies, Aged, Lumbar Vertebrae, Treatment Outcome, India, Denosumab therapeutic use, Denosumab pharmacokinetics, Denosumab administration & dosage, Denosumab adverse effects, Osteoporosis, Postmenopausal drug therapy, Biosimilar Pharmaceuticals therapeutic use, Biosimilar Pharmaceuticals adverse effects, Biosimilar Pharmaceuticals pharmacokinetics, Bone Density Conservation Agents therapeutic use, Bone Density Conservation Agents adverse effects, Bone Density Conservation Agents administration & dosage, Bone Density drug effects
Abstract

Objective: Denosumab, a human monoclonal antibody that exhibits strong affinity and specificity for the receptor activator of nuclear factor-kappa B ligand (RANK-L), is essential in regulating bone turnover. Its inhibition of RANK-L decreases bone resorption by preventing the development, function, and survival of osteoclasts. The objective of the study was to evaluate and compare the efficacy and safety of biosimilar denosumab with the reference product, Prolia (denosumab), in Indian women suffering from postmenopausal osteoporosis., Methods: This phase III study was a prospective, active-controlled, randomized, double-blind trial that included postmenopausal women diagnosed with osteoporosis. Participants were randomly allocated in a 2:1 ratio to receive either the biosimilar denosumab (Treatment A) or the reference denosumab (Prolia®; Treatment B). All participants also received daily supplementation of 500 international units (IU) of vitamin D3 and 1000 mg calcium. The primary outcomes measured were the bone mineral density (BMD) percentage change at the lumbar spine and the neck of femur, while the secondary endpoint assessed changes in biomarkers from baseline at months 6 and 12., Results: The lumbar spine BMD percentage change for group A vs group B from baseline to month 6 was 5.69 ± 0.88 ( p < 0.0001) vs 5.08 ± 1.19 ( p < 0.0001), and at 12 months was 7.26 ± 1.05 ( p < 0.0001) vs 7.31 ± 1.40 ( p < 0.0001), demonstrating equivalent efficacy. Both treatment groups showed statistically significant improvement in femoral neck BMD at 12 months. No statistically significant difference was noted in the ln-transformed primary pharmacokinetic parameters, including C-max, AUC0-120d, and AUC0-∞., Conclusion: Biosimilar denosumab was comparable to reference denosumab with respect to its efficacy, safety, pharmacokinetics (PK), pharmacodynamics, and immunogenicity in women with postmenopausal osteoporosis. Thus, biosimilar denosumab is expected to improve the quality of life in osteoporotic patients at affordable prices., (© Journal of The Association of Physicians of India 2025.)

Published
2025
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12. Functional and Radiological Outcome of Simultaneous Bilateral Total Knee Replacement in a Tertiary Care Centre : A Quasi-prospective Study.

Author

Singh J, Cherian JJ, and Lal JV

Abstract

Introduction: Osteoarthritis (OA) is the most frequent joint disease with a prevalence of 5313 per 100,000 persons in India. OA of the knee is a major contributor to mobility impairment, particularly among women. In these patients, total knee replacement (TKR) is widely accepted as the gold standard treatment for pain relief and restoration of function. Now, patients have the option of undergoing either a simultaneous bilateral TKR or a staged TKR. The former has shown significant advantages such as shorter rehabilitation, cost efficacy and shorter hospital stay. This study aimed to assess the functional and radiological outcome of simultaneous bilateral TKR in a tertiary care centre., Materials and Methods: 30 adult patients above the age of 55 years with severe OA knee who underwent simultaneous bilateral TKR between 2022-2023 were included in this prospective study. Preoperatively, they were assessed with radiographs including full length scannograms. Mean Anatomical Axis, Mean Mechanical Axis and Mechanical Axis Deviation (Varus) were calculated based on the scannograms by a single observer. The same observer administered the oxford knee score (OKS) preoperatively to all patients. Regular clinical and radiological follow up was done. After 1 year follow up, the same observer administered the Oxford Knee Score (OKS) to the operated knee., Results: With a female preponderance among the study subjects (56.7%), the majority of the cases in our cohort were characterised as Grade IV Kellgren-Lawrence radiological grade of Osteoarthritis (76.66%) and were found to have tricompartmental involvement (70%). The mean anatomical axis for the right and left lower limb were 4.56±5.17 and 9.68±1.72 respectively. The mean mechanical axis deviation (Varus) for the right and left lower limb were 31.6±15.1 and 52.0±13.9 respectively. Preoperatively, mean mechanical axis for the right and left lower limb were 9.95±4.31 and 14.2 ±0.67 respectively. Postoperatively, mechanical axis was restored to near-normal values (3-5 degrees). Significant improvement in mean OKS from a preoperative value of 18.30 ± 3.46 to postoperative value of 33.50 ± 5.32 was noted at 1 year., Conclusion: Treatment of severe bilateral OA knee with simultaneous single staged bilateral TKR ensures good functional outcome , early mobility with minimal complications., Competing Interests: Conflict of Interest: Nil, (Copyright: © Indian Orthopaedic Research Group.)

Published
2024
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