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1. Safety of apixaban in Indian patients undergoing elective total knee replacement or total hip replacement surgery: A multi-center, phase-IV study

Author

Himanshu C Panchal, Santosh R Taur, Namrata B. Kulkarni, Parag K Sancheti, and Abhijit Agashe

Subjects
venous, medicine.medical_specialty, Medicine (General), medicine.drug_class, business.industry, anticoagulant, Anticoagulant, Total knee replacement, Total hip replacement, General Medicine, thromboembolism, total hip replacement, Total hip replacement surgery, Surgery, R5-920, medicine, Apixaban, Original Research Article, business, Venous thromboembolism, medicine.drug
Abstract

Background: Venous thromboembolism is a significant source of morbidity and mortality following total hip replacement and total knee replacement. Apixaban has been proven to be efficacious without increased risk of bleeding in phase-III trials in patients undergoing total knee replacement and total hip replacement. Due to paucity of data on safety of apixaban in Indian patients, this phase-IV study was conducted to evaluate safety of apixaban in patients undergoing total knee replacement and total hip replacement. Methods: In this non-comparative phase-IV clinical trial, patients undergoing elective total knee replacement or total hip replacement surgery, or a revision of at least one component of total knee replacement or total hip replacement, were enrolled. The eligible patients were given the approved dosage of apixaban 12 to 24 h after completing the skin wound closure. The primary safety outcome was the composite of the International Society on Thrombosis and Haemostasis–defined major bleeding and clinically relevant non-major bleeding events at the end of the treatment. The secondary efficacy endpoint was the composite of venous thromboembolism/all-cause death at the end of the treatment. Results: A total of 498 patients received apixaban prophylaxis therapy. Six (1.2%) bleeding adverse events were observed during the treatment period. Only one bleeding event was adjudicated as an International Society on Thrombosis and Haemostasis–defined clinically relevant non-major bleeding event (moderate severity). There were no fatal bleeding events and no deaths following the treatment. One venous thromboembolism event, that is, symptomatic distal left leg DVT, was reported in a total knee replacement patient and was adjudicated during the treatment period. Conclusion: Apixaban demonstrated a favorable safety profile for venous thromboembolism prevention in Indian patients undergoing total knee replacement or total hip replacement.

Published
2021

2. Return to sport following anterior cruciate ligament reconstruction: the argument for a multimodal approach to optimise decision-making: current concepts

Author

Deepak V. Chona, Parag K Sancheti, Matteo Denti, Seth L. Sherman, Karl Eriksson, Simon W. Young, and Marc R. Safran

Subjects
medicine.medical_specialty, Anterior cruciate ligament reconstruction, Anterior cruciate ligament, medicine.medical_treatment, Functional testing, 03 medical and health sciences, 0302 clinical medicine, Physical medicine and rehabilitation, medicine, Humans, Orthopedics and Sports Medicine, Anterior Cruciate Ligament, 030222 orthopedics, biology, Anterior Cruciate Ligament Reconstruction, Athletes, Anterior Cruciate Ligament Injuries, Multimodal therapy, 030229 sport sciences, biology.organism_classification, Cognitive test, Return to Sport, Identification (information), medicine.anatomical_structure, Ligament, Surgery, Sports
Abstract

Existing literature is varied in the methods used to make this determination in the treatment of athletes who have undergone recent anterior cruciate ligament (ACL) reconstruction. Some authors report using primarily time-based criteria, while others advocate for physical measures and kinematic testing to inform decision-making. The goal of this paper is to elucidate the most current medical evidence regarding identification of the earliest point at which a patient may safely return to sport. The present review therefore seeks to examine the evidence from a critical perspective-breaking down the biology of graft maturation, effect of graft choice, potential for image-guided monitoring of progression and results associated with time-based versus functional criteria-based return to play-to justify a multifactorial approach to effectively advance athletes to return to sport. The findings of the present study reaffirm that time is a prerequisite for the biological progression that must occur for a reconstructed ligament to withstand loads demanded by athletes during sport. Modifications of surgical techniques and graft selection may positively impact the rate of graft maturation, and evidence suggests that imaging studies may offer informative data to enhance monitoring of this process. Aspects of both functional and cognitive testing have also demonstrated utility in prior studies and consequently have been factored into modern proposed methods of determining the athlete's readiness for sport. Further work is needed to definitively determine the optimal method of clearing an athlete to return to sport after ACL reconstruction. Evidence to date strongly suggests a role of a multimodal algorithmic approach that factors in time, graft biology and functional testing in return-to-play decision-making after ACL reconstruction.Level of evidence: level V.

Published
2020

3. Accelerated surgery versus standard care in hip fracture (HIP ATTACK): an international, randomised, controlled trial

Author

Flavia K Borges, Mohit Bhandari, Ernesto Guerra-Farfan, Ameen Patel, Alben Sigamani, Masood Umer, Maria E Tiboni, Maria del Mar Villar-Casares, Vikas Tandon, Jordi Tomas-Hernandez, Jordi Teixidor-Serra, Victoria RA Avram, Mitchell Winemaker, Mmampapatla T Ramokgopa, Wojciech Szczeklik, Giovanni Landoni, Chew Yin Wang, Dilshad Begum, John D Neary, Anthony Adili, Parag K Sancheti, Abdel-Rahman Lawendy, Mariano Balaguer-Castro, Paweł Ślęczka, Richard J Jenkinson, Aamer Nabi Nur, Gavin CA Wood, Robert J Feibel, Stephen J McMahon, Alen Sigamani, Ekaterine Popova, Bruce M Biccard, Iain K Moppett, Patrice Forget, Paul Landais, Michael H McGillion, Jessica Vincent, Kumar Balasubramanian, Valerie Harvey, Yaiza Garcia-Sanchez, Shirley M Pettit, Leslie P Gauthier, Gordon H Guyatt, David Conen, Amit X Garg, Shrikant I Bangdiwala, Emilie P Belley-Cote, Maura Marcucci, Andre Lamy, Richard Whitlock, Yannick Le Manach, Dean A Fergusson, Salim Yusuf, PJ Devereaux, Laurent Veevaete, Bernard le Polain de Waroux, Patricia Lavand'homme, Olivier Cornu, Karim Tribak, Jean Cyr Yombi, Nassim Touil, Maike Reul, Jigme Tshering Bhutia, Carol Clinckaert, Dirk De Clippeleir, Justin de Beer, Diane L Simpson, Andrew Worster, Kim A Alvarado, Krysten K Gregus, Kelly H Lawrence, Darryl P Leong, Philip G Joseph, Patrick Magloire, Benjamin Deheshi, Stuart Bisland, Thomas J Wood, Daniel M Tushinski, David AJ Wilson, Clive Kearon, David D Cowan, Vickas Khanna, Amna Zaki, Janet C Farrell, Anne Marie MacDonald, Steven CW Wong, Arsha Karbassi, Douglas Steven Wright, Harsha Shanthanna, Ryan Coughlin, Moin Khan, Spencer Wikkerink, Faraaz A Quraishi, Waleed Kishta, Emil Schemitsch, Timothy Carey, Mark D Macleod, David W Sanders, Edward Vasarhelyi, Debra Bartley, George K Dresser, Christina Tieszer, Steven Shadowitz, Jacques S Lee, Stephen Choi, Hans J Kreder, Markku Nousiainen, Monica R Kunz, Ravianne Tuazon, Mopina Shrikumar, Bheeshma Ravi, David Wasserstein, David JG Stephen, Diane Nam, Patrick DG Henry, Stephen M Mann, Melanie T Jaeger, Marco LA Sivilotti, Christopher A Smith, Christopher C Frank, Heather Grant, Leone Ploeg, Jeff D Yach, Mark M Harrison, Aaron R Campbell, Ryan T Bicknell, Davide D Bardana, Katie McIlquham, Catherine Gallant, Samantha Halman, Venkatesh Thiruganasambandamoorth, Sara Ruggiero, William J Hadden, Brian P-J Chen, Stephanie A Coupal, Lisa M McLean, Hemant R Shirali, Syed Y Haider, Crystal A Smith, Evan Watts, David J Santone, Kevin Koo, Allan J Yee, Ademilola N Oyenubi, Aaron Nauth, Emil H Schemitsch, Timothy R Daniels, Sarah E Ward, Jeremy A Hall, Henry Ahn, Daniel B Whelan, Amit Atrey, Amir Khoshbin, David Puskas, Kurt Droll, Claude Cullinan, Jubin Payendeh, Tina Lefrancois, Lise Mozzon, Travis Marion, Michael J Jacka, James Greene, Matthew Menon, Robert Stiegelmahr, Derek Dillane, Marleen Irwin, Lauren Beaupre, Chad P Coles, Kelly Trask, Shelley MacDonald, J Andrew I Trenholm, William Oxner, C Glen Richardson, Niloofar Dehghan, Mehdi Sadoughi, Achal Sharma, Neil J White, Loretta Olivieri, Stephen B Hunt, Thomas R Turgeon, Eric R Bohm, Sarah Tran, Stephen M Giilck, Tom Hupel, Pierre Guy, Peter J O'Brien, Andrew W Duncan, Gordon A Crawford, Junlin Zhou, Yanrui Zhao, Yang Liu, Lei Shan, Anshi Wu, Juan Manuel Muñoz, Philippe Chaudier, Marion Douplat, Michel Henri Fessy, Vincent Piriou, Lucie Louboutin, Jean Stephane David, Arnaud Friggeri, Sebastien Beroud, Jean Marie Fayet, Frankie Ka Li Leung, Christian Xinshuo Fang, Dennis King Hang Yee, Parag Kantilal Sancheti, Chetan Vijay Pradhan, Atul Ashok Patil, Chetan Prabhakar Puram, Madhav Pandurang Borate, Kiran Bhalchandra Kudrimoti, Bharati Anil Adhye, Himanshu Vijaykumar Dongre, Bobby John, Valsamma Abraham, Ritesh Arvind Pandey, Arti Rajkumar, Preetha Elizabeth George, Manesh Stephen, Nitheesh Chandran, Mohammed Ashraf, AM Georgekutty, Ahamad Shaheel Sulthan, S Adinarayanan, Deep Sharma, Satish Prasad Barnawal, Srinivasan Swaminathan, Prasanna Udupi Bidkar, Sandeep Kumar Mishra, Jagdish Menon, Niranjan M, Varghese Zachariah K, Santosh Angad Hiremath, Madhusudhan NC, Abhijit Jawali, Kingsly Robert Gnanadurai, Carolin Elizabeth George, Tatarao Maddipati, Mary KP KP, Vijay Sharma, Kamran Farooque, Rajesh Malhotra, Samarth Mittal, Chavi Sawhney, Babita Gupta, Purva Mathur, Shivanand Gamangati, Vijaylaxmi Tripathy, Prem Haridas Menon, Mandeep S Dhillon, Devendra K Chouhan, Sharanu Patil, Ravi Narayan, Purushotham Lal, Prashanth Nabhirajappa Bilchod, Surya Udai Singh, Uttam Vaidya Gattu, Ravi Prabhakar Dashputra, Prashant Vitthal Rahate, Maurizio Turiel, Giuseppe De Blasio, Riccardo Accetta, Paolo Perazzo, Daniele Stella, Marika Bonadies, Chiara Colombo, Stefania Fozzato, Fabio Pino, Ilaria Morelli, Eleonora Colnaghi, Vincenzo Salini, Giuseppe Denaro, Luigi Beretta, Giacomo Placella, Giuseppe Giardina, Mirko Binda, Anna Marcato, Luca Guzzetti, Fabio Piccirillo, Maurizio Cecconi, HM Khor, Hou Yee Lai, CS Kumar, KH Chee, PS Loh, Kit Mun Tan, Simmrat Singh, Li Lian Foo, Komella Prakasam, Sook Hui Chaw, Meng-Li Lee, Joanne HL Ngim, Huck Wee Boon, Im Im Chin, Ydo V Kleinlugtenbelt, Ellie BM Landman, Elvira R Flikweert, Herbert W Roerdink, Roy B.G. Brokelman, Hannie F Elskamp-Meijerman, Maarten R Horst, Jan-Hein MG Cobben, Anila Anjum, Pervaiz Mehmood Hashmi, Tashfeen Ahmed, Haroon Ur Rashid, Mujahid Jamil Khattak, Rizwan Haroon Rashid, Riaz Hussain Lakdawala, Shahryar Noordin, Naveed Muhammed Juman, Robyna Irshad Khan, Muhammad Mehmood Riaz, Syedah Saira Bokhari, Ayesha Almas, Hussain Wahab, Arif Ali, Hammad Naqi Khan, Eraj Khurshid Khan, Kholood Abid Janjua, Sajjad Hassan Orakzai, Abdus Salam Khan, Khawaja Junaid Mustafa, Mian Amjad Sohail, Muhammad Umar, Siddra Ahmed Khan, Muhammad Ashraf, Muhammad Kashif Khan, Muhammad Shiraz, Ahmad Furgan, Piotr Dąbek, Adam Kumoń, Wojciech Satora, Wojciech Ambroży, Mariusz Święch, Jacek Rycombel, Adrian Grzelak, Jaroslaw Gucwa, Waldemar Machala, Mmampapatla Thomas Ramokgopa, Gregory Bodley Firth, Mwalimu Karera, Maria Fourtounas, Virsen Singh, Anna Biscardi, Muhammad Nasir Iqbal, Ryan Jonathan Campbell, Matimba Lenny Maluleke, Carien Moller, Lerato Nhlapo, Sithombo Maqungo, Margot Flint, Marcin B Nejthardt, Sean Chetty, Rubendren Naidoo, Miriam Garrido Clua, Vicente Molero-Garcia, Joan Minguell-Monyart, Jordi Selga Marsa, Juan A Porcel-Vazquez, Jose-Vicente Andres-Peiro, Marc Aguilar, Jaume Mestre-Torres, Maria J Colomina, Patricia Guilabert, M Luisa Paños Gozalo, Luis Abarca, Nuria Martin, Gemma Usua, Pedro Martinez-Ripol, MA Gonzalez Posada, Pilar Lalueza-Broto, Judith Sanchez-Raya, Jorge Nuñez Camarena, Antoni Fraguas-Castany, Pere Torner, Monsant Jornet-Gibert, Jorge Serrano-Sanz, Jaume Cámara-Cabrera, Mònica Salomó-Domènech, Christian Yela-Verdú, Anna Peig-Font, Laura Ricol, Anna Carreras-Castañer, Luis Martínez-Sañudo, Susana Herranz, Carlos Feijoo-Massó, Mònica Sianes-Gallén, Pablo Castillón, Martí Bernaus, Saioa Quintas, Olga Gómez, Jordi Salvador, Javiera Abarca, Cristina Estrada, Marga Novellas, Mercè Torra, Alfred Dealbert, Oscar Macho, Alexia Ivanov, Esther Valldosera, Marta Arroyo, Borja Pey, Antoni Yuste, Llorenç Mateo, Julio De Caso, Rafael Anaya, JL Higa-Sansone, Angelica Millan, Victoria Baños, Sergio Herrera-Mateo, Hector J Aguado, Gonzalo Martinez-Municio, Ricardo León, Silvia Santiago-Maniega, Ana Zabalza, Gregorio Labrador, Enrique Guerado, Encarnacion Cruz, Juan Ramon Cano, Jose Manuel Bogallo, Paphon Sa-ngasoongsong, Noratep Kulachote, Norachart Sirisreetreerux, Nachapan Pengrung, Theerawat Chalacheewa, Vanlapa Arnuntasupakul, Teerapat Yingchoncharoen, Bundit Naratreekoon, Miriam Adel Kadry, Surendini Thayaparan, Ihab Abdlaziz, Arash Aframian, Arjuna Imbuldeniya, Souad Bentoumi, Sherif Omran, Marcela Paola Vizcaychipi, Patricia Correia, Shashank Patil, Kevin Haire, Amy SE Mayor, Sally Dillingham, Laura Nicholson, Mohamed Elnaggar, Joby John, Shashi Kumar Nanjayan, Martyn J Parker, Susan O'Sullivan, Meir T Marmor, Amir Matityahu, Robert Trigg McClellan, Curt Comstock, Anthony Ding, Paul Toogood, Gerard Slobogean, Katherine Joseph, Robert O'Toole, Marcus Sciadini, Scott P Ryan, Molly E Clark, Charles Cassidy, Konstantin Balonov, Sergio D Bergese, Laura S Phieffer, Alicia A Gonzalez Zacarias, Andrew J Marcantonio, Sanela Dragic-Taylor, Chelsea Maxwell, Sarah Molnar, Jennifer R Wells, Sandra N Ofori, Stephen S Yang, Michael K Wang, Emmanuelle Duceppe, Jessica Spence, Javiera P Vasquez, Francesc Marcano-Fernández, Hyungjoo Ham, Carlos Prada, Terence CH Yung, Isidro Sanz Pérez, Michael J Bosch, Michael R Prystajecky, Chinmoy Chowdhury, James S Khan, Steffan F Stella, Behrouz Heidary, Allen Tran, Katarzyna Wawrzycka-Adamczyk, Yu Chiao Peter Chen, Aránzazu González-Osuna, Grzegorz Biedroń, Anna Wludarczyk, Marco Lefebvre, Jaclyn A Ernst, Bas Staffhorst, Jason D Woodfine, Emad M Alwafi, Marko Mrkobrada, Simon Parlow, Robin Roberts, Finlay McAlister, David Sackett, James Wright, (HIP ATTACK, Investigators), Landoni, G., Faculty of Medicine and Pharmacy, Orthopaedics - Traumatology, Supporting clinical sciences, Emergency Medicine, UCL - SSS/IONS - Institute of NeuroScience, UCL - SSS/IONS/CEMO - Pôle Cellulaire et moléculaire, UCL - SSS/IREC/NMSK - Neuro-musculo-skeletal Lab, UCL - SSS/IREC/SLUC - Pôle St.-Luc, UCL - (SLuc) Service d'anesthésiologie, UCL - (SLuc) Service d'orthopédie et de traumatologie de l'appareil locomoteur, and UCL - (SLuc) Service de médecine interne générale

Subjects
Postoperative Complications/epidemiology, Male, Internationality, Femoral Neck Fractures/epidemiology, Arthroplasty, Replacement, Hip, Myocardial Ischemia, Comorbidity, Time-to-Treatment/statistics & numerical data, 030204 cardiovascular system & hematology, law.invention, Fracture Fixation, Internal, Postoperative Complications, 0302 clinical medicine, Randomized controlled trial, Residence Characteristics, law, Activities of Daily Living, Fracture fixation, Risk of mortality, Medicine and Health Sciences, Fracture Fixation, Internal/methods, Sepsis/epidemiology, 030212 general & internal medicine, Cardiovascular Diseases/mortality, Stroke, Aged, 80 and over, Hip fracture, Residence Characteristics/statistics & numerical data, Infections/epidemiology, General Medicine, Middle Aged, Open Fracture Reduction, Treatment Outcome, Cardiovascular Diseases, Diabetes Mellitus/epidemiology, Female, medicine.medical_specialty, Hip Fractures/epidemiology, Postoperative Hemorrhage, Infections, Early Medical Intervention/methods, Time-to-Treatment, 03 medical and health sciences, Arthroplasty, Replacement, Hip/methods, Early Medical Intervention, Sepsis, Diabetes Mellitus, medicine, Humans, Mortality, Myocardial Ischemia/epidemiology, Aged, Proportional Hazards Models, Postoperative Hemorrhage/epidemiology, Hip Fractures, Proportional hazards model, business.industry, Hemiarthroplasty/methods, Dementia/epidemiology, Delirium, Delirium/epidemiology, medicine.disease, Femoral Neck Fractures, Nursing Homes, Surgery, Open Fracture Reduction/methods, Dementia, Observational study, Hemiarthroplasty, business
Abstract

© 2020 Elsevier Ltd Background: Observational studies have suggested that accelerated surgery is associated with improved outcomes in patients with a hip fracture. The HIP ATTACK trial assessed whether accelerated surgery could reduce mortality and major complications. Methods: HIP ATTACK was an international, randomised, controlled trial done at 69 hospitals in 17 countries. Patients with a hip fracture that required surgery and were aged 45 years or older were eligible. Research personnel randomly assigned patients (1:1) through a central computerised randomisation system using randomly varying block sizes to either accelerated surgery (goal of surgery within 6 h of diagnosis) or standard care. The coprimary outcomes were mortality and a composite of major complications (ie, mortality and non-fatal myocardial infarction, stroke, venous thromboembolism, sepsis, pneumonia, life-threatening bleeding, and major bleeding) at 90 days after randomisation. Patients, health-care providers, and study staff were aware of treatment assignment, but outcome adjudicators were masked to treatment allocation. Patients were analysed according to the intention-to-treat principle. This study is registered at ClinicalTrials.gov (NCT02027896). Findings: Between March 14, 2014, and May 24, 2019, 27 701 patients were screened, of whom 7780 were eligible. 2970 of these were enrolled and randomly assigned to receive accelerated surgery (n=1487) or standard care (n=1483). The median time from hip fracture diagnosis to surgery was 6 h (IQR 4–9) in the accelerated-surgery group and 24 h (10–42) in the standard-care group (p

Published
2020

5. Reconstruction of Bone Defects After Osteomyelitis with Nonvascularized Fibular Graft

Author

Ashok Shyam, Sandeep Patwardhan, Rujuta Mehta, Hardik Agrawat, Parag K Sancheti, and Rustom Adi Mody

Subjects
Male, medicine.medical_specialty, medicine.medical_treatment, Nonunion, Bone and Bones, law.invention, Intramedullary rod, Fixation (surgical), External fixation, law, Fracture fixation, medicine, Humans, Orthopedics and Sports Medicine, Kirschner wire, Child, Retrospective Studies, Bone Transplantation, business.industry, Osteomyelitis, General Medicine, Plastic Surgery Procedures, medicine.disease, Fracture Fixation, Intramedullary, Surgery, Debridement, Fibula, Sequestrectomy, Child, Preschool, Wounds and Injuries, Female, business
Abstract

Background: Persistent infection, soft-tissue fibrosis, and damage to periosteum compound the treatment of children with a bone defect following osteomyelitis. We report on a series of twenty-six patients treated with nonvascularized fibular graft and intramedullary fixation. Methods: The series included eleven boys and fifteen girls (mean age, 6.8 years; range, three to twelve years) with gap nonunion after osteomyelitis. Initial treatment involved thorough debridement and sequestrectomy. When the infection was quiescent as indicated by inflammatory parameters, nonvascular fibular grafting with intramedullary Kirschner wire fixation (with or without additional external fixation) was performed. The time to union was noted, and a subgroup analysis was performed to correlate the size of the bone defect with the time to union. Results: The mean duration of follow-up was 3.02 ± 0.74 years (range, 1.3 to 4.2 years), and the mean time to union was 38.76 ± 12.02 weeks (range, fifteen to sixty weeks). There was a weak positive correlation between the time to union and the preoperative bone defect size (Pearson correlation coefficient, 0.699). The mean time to union was 31.7 ± 11.5 weeks for a defect of 6 cm. Delayed union was seen at one end of the fibular graft in four (15%) of the patients and was treated with plate fixation. One patient had recurrence of infection. Limb-length discrepancy (range, 2 to 5 cm) was seen in all patients in whom the lower limb was involved and was treated with a shoe lift. Conclusions: This series illustrates the potential benefits of staged sequestrectomy and nonvascular fibular grafting for the treatment of gap nonunion following osteomyelitis in children. The procedure is simple, does not require specialized training or equipment, and has a low complication rate. Level of Evidence: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Published
2013
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