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1. Aqueous skin antisepsis before surgical fixation of open fractures (Aqueous-PREP): a multiple-period, cluster-randomised, crossover trial

Author

Gerard P. Slobogean, Sheila Sprague, Jeffrey L. Wells, Mohit Bhandari, Anthony D. Harris, C. Daniel Mullins, Lehana Thabane, Amber Wood, Gregory J. Della Rocca, Joan N. Hebden, Kyle J. Jeray, Lucas S. Marchand, Lyndsay M. O'Hara, Robert D. Zura, Christopher Lee, Joseph T. Patterson, Michael J. Gardner, Jenna Blasman, Jonah Davies, Stephen Liang, Monica Taljaard, PJ Devereaux, Gordon Guyatt, Diane Heels-Ansdell, Debra Marvel, Jana E. Palmer, Jeff Friedrich, Nathan N. O'Hara, Frances Grissom, I. Leah Gitajn, Saam Morshed, Robert V. O'Toole, Bradley Petrisor, Franca Mossuto, Manjari G. Joshi, Jean-Claude G. D'Alleyrand, Justin Fowler, Jessica C. Rivera, Max Talbot, David Pogorzelski, Shannon Dodds, Silvia Li, Gina Del Fabbro, Olivia Paige Szasz, Sofia Bzovsky, Paula McKay, Alexandra Minea, Kevin Murphy, Andrea L. Howe, Haley K. Demyanovich, Wayne Hoskins, Michelle Medeiros, Genevieve Polk, Eric Kettering, Nirmen Mahal, Andrew Eglseder, Aaron Johnson, Christopher Langhammer, Christopher Lebrun, Jason Nascone, Raymond Pensy, Andrew Pollak, Marcus Sciadini, Yasmin Degani, Heather Phipps, Eric Hempen, Herman Johal, Bill Ristevski, Dale Williams, Matthew Denkers, Krishan Rajaratnam, Jamal Al-Asiri, Jodi L. Gallant, Kaitlyn Pusztai, Sarah MacRae, Sara Renaud, John D. Adams, Michael L. Beckish, Christopher C. Bray, Timothy R. Brown, Andrew W. Cross, Timothy Dew, Gregory K. Faucher, Richard W. Gurich Jr, David E. Lazarus, S. John Millon, M. Christian Moody, M. Jason Palmer, Scott E. Porter, Thomas M. Schaller, Michael S. Sridhar, John L. Sanders, L. Edwin Rudisill Jr, Michael J. Garitty, Andrew S. Poole, Michael L. Sims, Clark M. Walker, Robert Carlisle, Erin A. Hofer, Brandon Huggins, Michael Hunter, William Marshall, Shea B. Ray, Cory Smith, Kyle M. Altman, Erin R. Pichiotino, Julia C. Quirion, Markus F. Loeffler, Austin A. Cole, Ethan J. Maltz, Wesley Parker, T. Bennett Ramsey, Alex Burnikel, Michael Colello, Russell Stewart, Jeremy Wise, Matthew Anderson, Joshua Eskew, Benjamin Judkins, James M. Miller, Stephanie L. Tanner, Rebecca G. Snider, Christine E. Townsend, Kayla H. Pham, Abigail Martin, Emily Robertson, Emily Bray, J. Wilson Sykes, Krystina Yoder, Kelsey Conner, Harper Abbott, Roman M. Natoli, Todd O. McKinley, Walter W. Virkus, Anthony T. Sorkin, Jan P. Szatkowski, Brian H. Mullis, Yohan Jang, Luke A. Lopas, Lauren C. Hill, Courteney L. Fentz, Maricela M. Diaz, Krista Brown, Katelyn M. Garst, Emma W. Denari, Patrick Osborn, Sarah N. Pierrie, Bradley Kessler, Maria Herrera, Theodore Miclau, Meir T. Marmor, Amir Matityahu, R. Trigg McClellan, David Shearer, Paul Toogood, Anthony Ding, Jothi Murali, Ashraf El Naga, Jennifer Tangtiphaiboontana, Tigist Belaye, Eleni Berhaneselase, Dmitry Pokhvashchev, William T. Obremskey, Amir Alex Jahangir, Manish Sethi, Robert Boyce, Daniel J. Stinner, Phillip P. Mitchell, Karen Trochez, Elsa Rodriguez, Charles Pritchett, Natalie Hogan, A. Fidel Moreno, Jennifer E. Hagen, Matthew Patrick, Richard Vlasak, Thomas Krupko, Michael Talerico, Marybeth Horodyski, Marissa Pazik, Elizabeth Lossada-Soto, Joshua L. Gary, Stephen J. Warner, John W. Munz, Andrew M. Choo, Timothy S. Achor, Milton L. 'Chip' Routt, Michael Kutzler, Sterling Boutte, Ryan J. Warth, Michael J. Prayson, Indresh Venkatarayappa, Brandon Horne, Jennifer Jerele, Linda Clark, Christina Boulton, Jason Lowe, John T. Ruth, Brad Askam, Andrea Seach, Alejandro Cruz, Breanna Featherston, Robin Carlson, Iliana Romero, Isaac Zarif, Niloofar Dehghan, Michael McKee, Clifford B. Jones, Debra L. Sietsema, Alyse Williams, Tayler Dykes, Ernesto Guerra-Farfan, Jordi Tomas-Hernandez, Jordi Teixidor-Serra, Vicente Molero-Garcia, Jordi Selga-Marsa, Juan Antonio Porcel-Vazquez, Jose Vicente Andres-Peiro, Ignacio Esteban-Feliu, Nuria Vidal-Tarrason, Jordi Serracanta, Jorge Nuñez-Camarena, Maria del Mar Villar-Casares, Jaume Mestre-Torres, Pilar Lalueza-Broto, Felipe Moreira-Borim, Yaiza Garcia-Sanchez, Francesc Marcano-Fernández, Laia Martínez-Carreres, David Martí-Garín, Jorge Serrano-Sanz, Joel Sánchez-Fernández, Matsuyama Sanz-Molero, Alejandro Carballo, Xavier Pelfort, Francesc Acerboni-Flores, Anna Alavedra-Massana, Neus Anglada-Torres, Alexandre Berenguer, Jaume Cámara-Cabrera, Ariadna Caparros-García, Ferran Fillat-Gomà, Ruben Fuentes-López, Ramona Garcia-Rodriguez, Nuria Gimeno-Calavia, Marta Martínez-Álvarez, Patricia Martínez-Grau, Raúl Pellejero-García, Ona Ràfols-Perramon, Juan Manuel Peñalver, Mònica Salomó Domènech, Albert Soler-Cano, Aldo Velasco-Barrera, Christian Yela-Verdú, Mercedes Bueno-Ruiz, Estrella Sánchez-Palomino, Vito Andriola, Matilde Molina-Corbacho, Yeray Maldonado-Sotoca, Alfons Gasset-Teixidor, Jorge Blasco-Moreu, Núria Fernández-Poch, Josep Rodoreda-Puigdemasa, Arnau Verdaguer-Figuerola, Heber Enrique Cueva-Sevieri, Santiago Garcia-Gimenez, Darius G. Viskontas, Kelly L. Apostle, Dory S. Boyer, Farhad O. Moola, Bertrand H. Perey, Trevor B. Stone, H. Michael Lemke, Ella Spicer, Kyrsten Payne, Robert A. Hymes, Cary C. Schwartzbach, Jeff E. Schulman, A. Stephen Malekzadeh, Michael A. Holzman, Greg E. Gaski, Jonathan Wills, Holly Pilson, Eben A. Carroll, Jason J. Halvorson, Sharon Babcock, J. Brett Goodman, Martha B. Holden, Wendy Williams, Taylor Hill, Ariel Brotherton, Nicholas M. Romeo, Heather A. Vallier, Anna Vergon, Thomas F. Higgins, Justin M. Haller, David L. Rothberg, Zachary M. Olsen, Abby V. McGowan, Sophia Hill, Morgan K. Dauk, Patrick F. Bergin, George V. Russell, Matthew L. Graves, John Morellato, Sheketha L. McGee, Eldrin L. Bhanat, Ugur Yener, Rajinder Khanna, Priyanka Nehete, David Potter, Robert VanDemark III, Kyle Seabold, Nicholas Staudenmier, Marcus Coe, Kevin Dwyer, Devin S. Mullin, Theresa A. Chockbengboun, Peter A. DePalo Sr., Kevin Phelps, Michael Bosse, Madhav Karunakar, Laurence Kempton, Stephen Sims, Joseph Hsu, Rachel Seymour, Christine Churchill, Ada Mayfield, Juliette Sweeney, Todd Jaeblon, Robert Beer, Brent Bauer, Sean Meredith, Sneh Talwar, Christopher M. Domes, Mark J. Gage, Rachel M. Reilly, Ariana Paniagua, JaNell Dupree, Michael J. Weaver, Arvind G. von Keudell, Abigail E. Sagona, Samir Mehta, Derek Donegan, Annamarie Horan, Mary Dooley, Marilyn Heng, Mitchel B. Harris, David W. Lhowe, John G. Esposito, Ahmad Alnasser, Steven F. Shannon, Alesha N. Scott, Bobbi Clinch, Becky Weber, Michael J. Beltran, Michael T. Archdeacon, Henry Claude Sagi, John D. Wyrick, Theodore Toan Le, Richard T. Laughlin, Cameron G. Thomson, Kimberly Hasselfeld, Carol A. Lin, Mark S. Vrahas, Charles N. Moon, Milton T. Little, Geoffrey S. Marecek, Denice M. Dubuclet, John A. Scolaro, James R. Learned, Philip K. Lim, Susan Demas, Arya Amirhekmat, and Yan Marco Dela Cruz

Subjects
Adult, Male, Canada, Cross-Over Studies, Chlorhexidine, General Medicine, Antisepsis, Middle Aged, Fractures, Open, Anti-Infective Agents, Local, Humans, Surgical Wound Infection, Female, Povidone-Iodine
Abstract

Chlorhexidine skin antisepsis is frequently recommended for most surgical procedures; however, it is unclear if these recommendations should apply to surgery involving traumatic contaminated wounds where povidone-iodine has previously been preferred. We aimed to compare the effect of aqueous 10% povidone-iodine versus aqueous 4% chlorhexidine gluconate on the risk of surgical site infection in patients who required surgery for an open fracture.We conducted a multiple-period, cluster-randomised, crossover trial (Aqueous-PREP) at 14 hospitals in Canada, Spain, and the USA. Eligible patients were adults aged 18 years or older with an open extremity fracture treated with a surgical fixation implant. For inclusion, the open fracture required formal surgical debridement within 72 h of the injury. Participating sites were randomly assigned (1:1) to use either aqueous 10% povidone-iodine or aqueous 4% chlorhexidine gluconate immediately before surgical incision; sites then alternated between the study interventions every 2 months. Participants, health-care providers, and study personnel were aware of the treatment assignment due to the colour of the solutions. The outcome adjudicators and data analysts were masked to treatment allocation. The primary outcome was surgical site infection, guided by the 2017 US Centers for Disease Control and Prevention National Healthcare Safety Network reporting criteria, which included superficial incisional infection within 30 days or deep incisional or organ space infection within 90 days of surgery. The primary analyses followed the intention-to-treat principle and included all participants in the groups to which they were randomly assigned. This study is registered with ClinicalTrials.gov, NCT03385304.Between April 8, 2018, and June 8, 2021, 3619 patients were assessed for eligibility and 1683 were enrolled and randomly assigned to povidone-iodine (n=847) or chlorhexidine gluconate (n=836). The trial's adjudication committee determined that 45 participants were ineligible, leaving 1638 participants in the primary analysis, with 828 in the povidone-iodine group and 810 in the chlorhexidine gluconate group (mean age 44·9 years [SD 18·0]; 629 [38%] were female and 1009 [62%] were male). Among 1571 participants in whom the primary outcome was known, a surgical site infection occurred in 59 (7%) of 787 participants in the povidone-iodine group and 58 (7%) of 784 in the chlorhexidine gluconate group (odds ratio 1·11, 95% CI 0·74 to 1·65; p=0·61; risk difference 0·6%, 95% CI -1·4 to 3·4).For patients who require surgical fixation of an open fracture, either aqueous 10% povidone-iodine or aqueous 4% chlorhexidine gluconate can be selected for skin antisepsis on the basis of solution availability, patient contraindications, or product cost. These findings might also have implications for antisepsis of other traumatic wounds.US Department of Defense, Canadian Institutes of Health Research, McMaster University Surgical Associates, PSI Foundation.

Published
2022

2. Managing work flow in high enrolling trials: The development and implementation of a sampling strategy in the PREPARE trial

Author

David Pogorzelski, Uyen Nguyen, Paula McKay, Lehana Thabane, Megan Camara, Lolita Ramsey, Rachel Seymour, J. Brett Goodman, Sheketha McGee, Joanne Fraifogl, Andrea Hudgins, Stephanie L. Tanner, Mohit Bhandari, Gerard P. Slobogean, Sheila Sprague, Jeffrey Wells, Jean-Claude D'Alleyrand, Anthony D. Harris, Daniel C. Mullins, Amber Wood, Gregory J. Della Rocca, Joan Hebden, Kyle J. Jeray, Lucas Marchand, Lyndsay M. O'Hara, Robert Zura, Michael J. Gardner, Jenna Blasman, Jonah Davies, Stephen Liang, Monica Taljaard, P.J. Devereaux, Gordon H. Guyatt, Diane Heels-Ansdell, Debra Marvel, Jana Palmer, Jeff Friedrich, Nathan N. O'Hara, Ms. Frances Grissom, I. Leah Gitajn, Saam Morshed, Robert V. O'Toole, Bradley A. Petrisor, Franca Mossuto, Manjari G. Joshi, Justin Fowler, Jessica Rivera, Max Talbot, Shannon Dodds, Alisha Garibaldi, Silvia Li, Alejandra Rojas, Taryn Scott, Gina Del Fabbro, Olivia Paige Szasz, Andrea Howe, Joshua Rudnicki, Haley Demyanovich, Kelly Little, C. Daniel Mullins, Michelle Medeiros, Eric Kettering, Diamond Hale, Andrew Eglseder, Aaron Johnson, Christopher Langhammer, Christopher Lebrun, Theodore Manson, Jason Nascone, Ebrahim Paryavi, Raymond Pensy, Andrew Pollak, Marcus Sciadini, Yasmin Degani, Haley K. Demyanovich, Katherine Joseph, Brad A. Petrisor, Herman Johal, Bill Ristevski, Dale Williams, Matthew Denkers, Krishan Rajaratnam, Jamal Al-Asiri, Jordan Leonard, Francesc A. Marcano-Fernández, Jodi Gallant, Federico Persico, Marko Gjorgjievski, Annie George, Roman M. Natoli, Greg E. Gaski, Todd O. McKinley, Walter W. Virkus, Anthony T. Sorkin, Jan P. Szatkowski, Joseph R. Baele, Brian H. Mullis, Lauren C. Hill, Patrick Osborn, Sarah Pierrie, Eric Martinez, Joseph Kimmel, John D. Adams, Michael L. Beckish, Christopher C. Bray, Timothy R. Brown, Andrew W. Cross, Timothy Dew, Gregory K. Faucher, Richard W. Gurich, David E. Lazarus, S. John Millon, M. Jason Palmer, Scott E. Porter, Thomas M. Schaller, Michael S. Sridhar, John L. Sanders, L. Edwin Rudisill, Michael J. Garitty, Andrew S. Poole, Michael L. Sims, Clark M. Walker, Robert M. Carlisle, Erin Adams Hofer, Brandon S. Huggins, Michael D. Hunter, William A. Marshall, Shea Bielby Ray, Cory D. Smith, Kyle M. Altman, Julia C. Bedard, Markus F. Loeffler, Erin R. Pichiotino, Austin A. Cole, Ethan J. Maltz, Wesley Parker, T. Bennett Ramsey, Alex Burnikel, Michael Colello, Russell Stewart, Jeremy Wise, M. Christian Moody, Rebecca G. Snider, Christine E. Townsend, Kayla H. Pham, Abigail Martin, Emily Robertson, Theodore Miclau, Utku Kandemir, Meir Marmor, Amir Matityahu, R. Trigg McClellan, Eric Meinberg, David Shearer, Paul Toogood, Anthony Ding, Erin Donohue, Tigist Belaye, Eleni Berhaneselase, Alexandra Paul, Kartik Garg, Joshua L. Gary, Stephen J. Warner, John W. Munz, Andrew M. Choo, Timothy S. Achor, Milton L. 'Chip' Routt, Mayank Rao, Guillermo Pechero, Adam Miller, Jennifer E. Hagen, Matthew Patrick, Richard Vlasak, Thomas Krupko, Kalia Sadasivan, Chris Koenig, Daniel Bailey, Daniel Wentworth, Chi Van, Justin Schwartz, Niloofar Dehghan, Clifford B. Jones, J Tracy Watson, Michael McKee, Ammar Karim, Michael Talerico, Debra L. Sietsema, Alyse Williams, Tayler Dykes, William T. Obremskey, Amir Alex Jahangir, Manish Sethi, Robert Boyce, Daniel J. Stinner, Phillip Mitchell, Karen Trochez, Andres Rodriguez, Vamshi Gajari, Elsa Rodriguez, Charles Pritchett, Christina Boulton, Jason Lowe, Jason Wild, John T. Ruth, Michel Taylor, Andrea Seach, Sabina Saeed, Hunter Culbert, Alejandro Cruz, Thomas Knapp, Colin Hurkett, Maya Lowney, Michael Prayson, Indresh Venkatarayappa, Brandon Horne, Jennifer Jerele, Linda Clark, Francesc Marcano-Fernández, Montsant Jornet-Gibert, Laia Martínez-Carreres, David Martí-Garín, Jorge Serrano-Sanz, Joel Sánchez-Fernández, Matsuyama Sanz-Molero, Alejandro Carballo, Xavier Pelfort, Francesc Acerboni-Flores, Anna Alavedra-Massana, Neus Anglada-Torres, Alexandre Berenguer, Jaume Cámara-Cabrera, Ariadna Caparros-García, Ferran Fillat-Gomà, Ruben Fuentes-López, Ramona Garcia-Rodriguez, Nuria Gimeno-Calavia, Guillem Graells-Alonso, Marta Martínez-Álvarez, Patricia Martínez-Grau, Raúl Pellejero-García, Ona Ràfols-Perramon, Juan Manuel Peñalver, Mònica Salomó Domènech, Albert Soler-Cano, Aldo Velasco-Barrera, Christian Yela-Verdú, Mercedes Bueno-Ruiz, Estrella Sánchez-Palomino, Ernesto Guerra, Yaiza García, Nicholas M. Romeo, Heather A. Vallier, Mary A. Breslin, Eleanor S. Wilson, Leanne K. Wadenpfuhl, Paul G. Halliday, Darius G. Viskontas, Kelly L. Apostle, Dory S. Boyer, Farhad O. Moola, Bertrand H. Perey, Trevor B. Stone, H. Michael Lemke, Mauri Zomar, Ella Spicer, Chen 'Brenda' Fan, Kyrsten Payne, Kevin Phelps, Michael Bosse, Madhav Karunakar, Laurence Kempton, Stephen Sims, Joseph Hsu, Christine Churchill, Claire Bartel, Robert Miles Mayberry, Maggie Brownrigg, Cara Girardi, Ada Mayfield, Robert A. Hymes, Cary C. Schwartzbach, Jeff E. Schulman, A. Stephen Malekzadeh, Michael A. Holzman, James S. Ahn, Farhanaz Panjshiri, Sharmistha Das, Antoinisha D. English, Sharon M. Haaser, Jaslynn A.N. Cuff, Holly Pilson, Eben A. Carroll, Jason J. Halvorson, Sharon Babcock, Martha B. Holden, Debra Bullard, Wendy Williams, Thomas F. Higgins, Justin M. Haller, David L. Rothberg, Ashley Neese, Mark Russell, Marcus Coe, Kevin Dwyer, Devin S. Mullin, Clifford A. Reilly, Peter DePalo, Amy E. Hall, Marilyn Heng, Mitchel B. Harris, R. Malcolm Smith, David W. Lhowe, John G. Esposito, Mira Bansal, Patrick F. Bergin, George V. Russell, Matthew L. Graves, John Morellato, Heather K. Champion, Leslie N. Johnson, Sheketha L. McGee, Eldrin L. Bhanat, Samir Mehta, Derek Donegan, Jaimo Ahn, Annamarie Horan, Mary Dooley, Ashley Kuczinski, Ashley Iwu, David Potter, Robert VanDemark, Branden Pfaff, Troy Hollinsworth, Michael J. Weaver, Arvind G. von Keudell, Michael F. McTague, Elizabeth M. Allen, Todd Jaeblon, Robert Beer, Mark J. Gage, Rachel M. Reilly, and Cindy Sparrow

Subjects
Pragmatic, medicine.medical_specialty, Comparative effectiveness research, Pharmacy, Sampling framework, Cluster crossover, Sampling strategy, Article, Odds, 03 medical and health sciences, 0302 clinical medicine, Health care, medicine, 030212 general & internal medicine, Sampling, Pharmacology, lcsh:R5-920, Descriptive statistics, business.industry, Sampling (statistics), General Medicine, Test (assessment), Work flow, Family medicine, business, lcsh:Medicine (General), 030217 neurology & neurosurgery
Abstract

Author(s): Pogorzelski, David; Nguyen, Uyen; McKay, Paula; Thabane, Lehana; Camara, Megan; Ramsey, Lolita; Seymour, Rachel; Goodman, J Brett; McGee, Sheketha; Fraifogl, Joanne; Hudgins, Andrea; Tanner, Stephanie L; Bhandari, Mohit; Slobogean, Gerard P; Sprague, Sheila; PREP-IT Investigators Executive Committee:; Steering Committee; Adjudication Committee; Data and Safety Monitoring Committee; Research Methodology Core; Patient Centred Outcomes Core; Orthopaedic Surgery Core; Operating Room Core; Infectious Disease Core; Military Core; McMaster University Methods Center; University of Maryland School of Medicine Administrative Center; University of Maryland School of Pharmacy, The PATIENTS Program; PREP-IT Clinical Sites: Lead Clinical Site (Aqueous-PREP and PREPARE); Aqueous-PREP and PREPARE; Aqueous-PREP; PREPARE; PREP-IT Investigators Executive Committee | Abstract: IntroductionPragmatic trials in comparative effectiveness research assess the effects of different treatment, therapeutic, or healthcare options in clinical practice. They are characterized by broad eligibility criteria and large sample sizes, which can lead to an unmanageable number of participants, increasing the risk of bias and affecting the integrity of the trial. We describe the development of a sampling strategy tool and its use in the PREPARE trial to circumvent the challenge of unmanageable work flow.MethodsGiven the broad eligibility criteria and high fracture volume at participating clinical sites in the PREPARE trial, a pragmatic sampling strategy was needed. Using data from PREPARE, descriptive statistics were used to describe the use of the sampling strategy across clinical sites. A Chi-square test was performed to explore whether use of the sampling strategy was associated with a reduction in the number of missed eligible patients.Results7 of 20 clinical sites (35%) elected to adopt a sampling strategy. There were 1539 patients excluded due to the use of the sampling strategy, which represents 30% of all excluded patients and 20% of all patients screened for participation. Use of the sampling strategy was associated with lower odds of missed eligible patients (297/4545 (6.5%) versus 341/3200 (10.7%) p l 0.001).ConclusionsImplementing a sampling strategy in the PREPARE trial has helped to limit the number of missed eligible patients. This sampling strategy represents a simple, easy to use tool for managing work flow at clinical sites and maintaining the integrity of a large trial.

Published
2020

3. The Combined Olecranon Osteotomy, Lateral Paratricipital Sparing, Deltoid Insertion Splitting Approach for Concomitant Distal Intra-articular and Humeral Shaft Fractures

Author

Yuri M Lewicky, John T. Ruth, and Joseph E. Sheppard

Subjects
Adult, Male, Humeral Fractures, medicine.medical_specialty, medicine.medical_treatment, Olecranon, Deltoid curve, Poison control, Osteotomy, medicine, Humans, Orthopedic Procedures, Orthopedics and Sports Medicine, Humerus, Muscle, Skeletal, business.industry, Accidents, Traffic, General Medicine, Anatomy, medicine.anatomical_structure, Motorcycles, Orthopedic surgery, Fracture (geology), Surgery, Axillary nerve, business
Abstract

Fractures of the distal humerus involving the articular surface can be challenging. The complexity of these fracture patterns increases when the distal fracture is associated with a concomitant humeral shaft fracture with significant proximal extension. The combined exposure technique described here allows for consistent and controlled posterior humeral exposure proximally from the traverse of the axillary nerve to the distal trochlear tip. It is especially useful for complex segmental fracture patterns where distal intra-articular involvement is present and a single approach is desired.

Published
2007
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4. Capitellocondylar total elbow replacement. A long-term follow-up study

Author

Alan H. Wilde and John T. Ruth

Subjects
musculoskeletal diseases, medicine.medical_specialty, business.industry, medicine.medical_treatment, Elbow, General Medicine, musculoskeletal system, medicine.disease, Prosthesis, Asymptomatic, Ulnar neuropathy, Surgery, body regions, medicine.anatomical_structure, Rheumatoid arthritis, Orthopedic surgery, medicine, Deformity, Upper limb, Orthopedics and Sports Medicine, medicine.symptom, business
Abstract

Fifty-one capitellocondylar elbow replacements were inserted in forty-one patients between 1976 and 1986. Thirty-nine patients had rheumatoid arthritis and two had traumatic osteoarthrosis. The average age of the patients at the time of the operation was fifty-six years (range, twenty-one to seventy-seven years). Thirty-one patients who had thirty-nine retained elbow prostheses had an average length of follow-up of 6.5 years (range, two to thirteen years). Flexion improved an average of 20 degrees; extension, 4 degrees; pronation, 22 degrees; and supination, 36 degrees. Relief of pain was complete in 85 per cent of the thirty-nine elbows, and in 15 per cent there was only mild pain. Noteworthy postoperative complications in the original fifty-one elbows included infection in four elbows (8 per cent), dislocation in three (6 per cent), and ulnar neuropathy in sixteen (31 per cent). Three elbows were revised: one for a humeral fracture, one for recurrent dislocation, and one for aseptic loosening. Aseptic loosening was evident on radiographs of two elbows; one patient was completely asymptomatic, and one had mild pain with deformity. The Souter zonal radiographic assessment system for identification of radiolucencies at the bone-cement interface was utilized; there was no significant difference in radiolucencies between ulnar components backed with metal and those that were not backed with metal. Kaplan-Meier cumulative survivorship analysis demonstrated that a functional prosthesis was retained in 88 per cent of the elbows at 1.4 years postoperatively and in 83 per cent at 5.5 years.(ABSTRACT TRUNCATED AT 250 WORDS)

Published
1992
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5. Load transfer through a hydroxyapatite-coated canine hip implant

Author

John A. Szivek, John T. Ruth, Donald W. DeYoung, and R. C. Kersey

Subjects
Materials science, Strain (injury), Biocompatible Materials, Bone resorption, Hip implant, Dogs, medicine, Animals, Femur, Bone Resorption, General Engineering, Soft tissue, General Medicine, Anatomy, Equipment Design, medicine.disease, Apposition, Microscopy, Electron, medicine.anatomical_structure, Durapatite, Cortical bone, Implant, Hip Prosthesis, Stress, Mechanical, Biomedical engineering
Abstract

Strain transfer near hydroxyapatite (HA) coated canine hip implants was examined using simulated anatomical loading based on in vivo strain measurements. Strain changes near implants relative to intact control values were in excess of 100% for transverse and principal strains for zero time period (immediate postimplant) specimens. They were generally smaller (100% or less) for axial, transverse, and principal minimums in the same locations for 4 months postimplantation specimens. Cortical bone loss occurred in all implanted femora. The most extensive loss, up to 47%, occurred adjacent to the proximal section of the implant. Extensive trabecular bone formation, over 300% in some regions of each femur, was noted in all implanted femora. Backscattered electron imaging along the HA-coated sections of the implants showed extensive bone bonded to the coating. NOrmal light and UV light micrographs showed direct bone apposition to the implant surfaces and extensive bone formation in all test animals. Microscopy revealed no evidence of any soft tissue layer between the implant and bone. Bone was typically found in direct contact with the implant surface. Histomorphometry indicated that bone formation rates in the implanted femora were elevated, up to 850%, relative to controls. Fewer formation sites were noted on the posterior and lateral (in two cases zero sites). Mineral apposition rates (MAR) from two of the dogs were slightly elevated (from 110-113%) in the implanted femora relative to controls and depressed (to about 83% of controls) in a third.

Published
1994

6. 213 POROUS POLYBUTYLENE TEREPHTHALATE IMPLANTS ALLOW FOR BONE INGROWTH AND PROVIDE A WELL-ANCHORED SCAFFOLD THAT CAN BE USED TO DELIVER TISSUE-ENGINEERED CARTILAGE

Author

David S. Margolis, John T. Ruth, Donald W. DeYoung, A. B. Schnepp, John A. Szivek, Ranji Vaidyanathan, B. C. Tellis, C. L. Bliss, and Christopher P. Geffre

Subjects
Bone growth, Scaffold, Materials science, Osteoid, Cartilage, Tissue engineered cartilage, General Medicine, Anatomy, General Biochemistry, Genetics and Molecular Biology, Polybutylene terephthalate, chemistry.chemical_compound, medicine.anatomical_structure, chemistry, Articular cartilage repair, medicine, Porosity, Biomedical engineering
Abstract

While joint pain and loss of mobility are common causes of impairment, there are few procedures that can consistently restore the long-term function of damaged articular cartilage. One approach that offers a potential solution for articular cartilage repair is replacement of the damaged cartilage using a tissue-engineered scaffold. The goal of this study was to measure loading and bone attachment in sensate, porous, calcium phosphate ceramic (CPC) coated polybutylene terephthalate (PBT) scaffolds that have been implanted in the medial compartment of the knees of 6 canines. In addition histology, histomorphometry, and scanning electron microscopy (SEM) were used to characterize bone growth into and around the PBT scaffold. In vivo measurements from the calibrated scaffolds indicated that peak loads in the dog knees ranged from 80-120N. Post-sacrifice biomechanical testing indicated that these loads correlated to pressures of 11 ± 1.54 MPa in the medial compartment of the knees. Histology demonstrated a bone volume of 6.8 ± 8.8% within the scaffold pores and an osteoid volume of 64.9 ± 17.2%. Histomorphometry indicated an increased bone formation rate within the scaffold pores, 8.2E-5 ± 5.9E-5 μm3 /μm2 /day, compared to 1.3E-5 ± 0.8E-5 mm3 /μm2 /day in control knees. SEM demonstrated less bone within the scaffold pores compared to the extensive amount of bone surrounding the scaffold and in intimate contact with the CPC particles. These results demonstrate that the scaffold is mechanically coupled to the bone. In addition, the increased bone formation rate and osteoid within the PBT pores demonstrate that bone formation is still occurring 6 months post-op. Currently studies are focused on the integration of PBT scaffolds containing a tissue-engineered cartilage covering into damaged articular cartilage.

Published
2006
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7. Floating Knee Injuries and Compartment Syndrome

Author

J Robert, John T. Ruth, H. Jay Zwally, and C. Phillip Volk

Subjects
medicine.medical_specialty, business.industry, Medicine, Orthopedics and Sports Medicine, Surgery, General Medicine, business, Knee injuries, Compartment (pharmacokinetics)
Published
1993
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8. Two-Stage Reimplantation in Infected Total Knee Arthroplasty

Author

John T. Ruth and Alan H. Wilde

Subjects
medicine.medical_specialty, biology, business.industry, medicine.drug_class, Streptococcus, Antibiotics, General Medicine, Osteoarthritis, medicine.disease, Streptococcus bovis, biology.organism_classification, medicine.disease_cause, Group B, Surgery, Rheumatoid arthritis, medicine, Orthopedics and Sports Medicine, Coagulase, business, Staphylococcus
Abstract

Twenty-one infected total knee arthroplasties (TKA) in 21 patients were treated from September 1980 through October 1987. Of these, 15 were followed for more than one year. Treatment of these patients consisted of thorough debridement of all infected tissue and components; a cement spacer was used in ten patients. The cement was impregnated with antibiotics. This procedure was followed for an average of 4.2 weeks with intravenous antibiotics and TKA utilizing antibiotic-impregnated cement. Five patients had rheumatoid arthritis and ten had osteoarthritis. The organisms included Staphylococcus coagulase negative (seven patients), Streptococcus group B (two patients), Streptococcus bovis (one patient), Enterococcus (one patient), Staphylococcus coagulase positive and Bacillus circulans (one patient), Staphylococcus coagulase negative and Enterococcus (one patient), Staphylococcus coagulase negative and Pseudomonas aeuriginosa (one patient), and Clostridium perfringens (one patient). Of the 15 patients, 12 appeared to be free of infection, two were obvious failures and required knee fusion, and one was suspected of having continued infection at five years and was treated elsewhere. Eleven patients with revision TKA were available for follow-up examinations at an average of 2.9 years (range, one to six years). One patient died five years after reimplantation but had been functioning well. One patient functioning at three years postreimplantation did not return for a later follow-up examination. The average knee score (modification of the Hospital for Special Surgery Knee Score) was 75.5 points (range, 48-94); average flexion was 81 degrees (range, 52 degrees-120 degrees), and average extension was +6 degrees (range, 0 degrees-30 degrees).(ABSTRACT TRUNCATED AT 250 WORDS)

Published
1988
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