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ROSEMONT, Ill., Feb. 10, 2023 /PRNewswire/ -- The 2023 Kappa Delta Ann Doner Vaughn Award was given to Michelle Ghert, MD, FRCSC, on behalf of the Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY) investigators for their research on the prevention of surgical site infections (SSIs) through antibiotic prophylaxis following oncologic reconstruction surgery for bone tumors. Their work resulted in the first-ever international, multi-center randomized controlled trial (RCT) in orthopaedic oncology as well as the largest collaborative effort in orthopaedic surgery with regards to the number of countries collaborating. To read more about the award, please click here. Continue Reading The 2023 Kappa Delta Ann Doner Vaughn Award was given to Michelle Ghert, MD, FRCSC, on behalf of the Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY) investigators for their research on the prevention of surgical site infections (SSIs) through antibiotic prophylaxis following oncologic reconstruction surgery for bone tumors. "In the field of medicine, conducting a 600-patient randomized study isn't out of the ordinary," said Dr. Ghert, principal investigator, professor, Department of Surgery, McMaster University, Hamilton, Ontario, Canada. "However, in orthopaedic oncology, where we treat rare diseases, it was a shift in our research paradigm. While initially there wasn't much optimism that this study would work, we believed it was time to move forward for our patients and the research question really resonated. I give a lot of credit to the first few clinical sites that joined the study as they took a leap of faith." Bone sarcomas – malignant tumors of long bones in the arms or legs – are treated through limb salvage surgery which involves reconstructing the limb with implants.i While bone sarcomas are rare, making up less than 1% of all cancers, these typically affect younger patients.ii SSIs rates are high following surgery as it is a long and complex procedure, and the patient has a compromised immune system due to chemotherapy.i,iii SSIs can be devastating to patients, requiring revision surgery and long-term intravenous antibiotic therapy. Even so, reinfection and eventual amputation are common,iv greatly affecting patients' quality of life and increasing the overall healthcare costs.v To reduce SSIs in orthopaedic reconstruction surgery, antibiotics are used and typically discontinued after 24 hours as dictated by guidelines for other surgical procedures. However, with no studies examining the role of antibiotic regimens for surgical reconstruction of lower extremity bone tumors, there were no firm conclusions regarding antibiotic duration. The PARITY Steering Committee brought experts together from orthopaedic oncology, infectious diseases, clinical epidemiology, biostatistics and health research methodology to lead research on this issue. PARITY Trial Findings Prior to the PARITY trial, the team conducted several supportive studies that helped inform the design, implementation and feasibility of the PARTIY trial, including: a multinational survey of orthopaedic oncologists to determine standard SSI prevention practices a systematic review to determine a baseline SSI rate a trial protocol publication a qualitative study to understand the barriers and facilitators to collaborative perspective research in orthopaedic oncology a pilot randomized trial an assessment of blinded outcomes assessment for SSIs an a priori statistical analysis plan The PARITY trial was conducted across 55 clinical centers in 12 countries as a parallel, blinded RCT from January 2013 to October 2019. The study was led by Dr. Ghert in collaboration with the study lead in Europe, Roberto Velez, MD, PhD. The trial followed 604 patients with primary bone or soft-tissue sarcoma or oligometastatic (a more treatable form of metastatic cancer) bone disease in the femur or tibia with an expected survival of one year who required surgical resection and implant reconstruction. Patients were randomized to a one- or five-day regimen (311 to one day and 293 to five day) of post-operative intravenous antibiotics (cefazolin or cefuroxime) within eight hours of skin closure and then administered every eight hours after that. Patients, caregivers and outcome assessors were blinded to treatment allocation. The primary outcome focus was a SSI (superficial incisional, deep incisional or organ space) within one year and classified according to the Centers for Disease Control and Prevention (CDC) criteria. Additional secondary outcomes included antibiotic-related complications, unplanned reoperations, oncologic and functional outcomes and mortality. Patients were assessed at two and six weeks, three, six and nine months, and one year after surgery. The findings of the PARITY trial included: Fifteen percent of patients allocated to the five-day regimen and 16.7% on the one-day regimen had a SSI. The most common causes of SSIs were Staphylococcus aureus and coagulase-negative Staphylococci. There was a significant increase in antibiotic-related complications in the five-day regimen group, with the main complication reported to be antibiotic-associated diarrhea caused by Clostridioides difficile which can be severe and may lead to toxic megacolon, organ failure or even death.vi Other secondary outcomes didn't differ significantly between treatment groups. "The risk for SSI was not significantly different for five days or one day, so when surgeons write post-operative orders, they have that information to work with," said Dr. Ghert. "However, one of the secondary outcomes demonstrated you could actually hurt the patient by causing severe antibiotic-related complications that can be life altering. When you have a patient who is already going through a very difficult time, chemotherapy and morbid surgery, surgeons need to weigh the risk before prescribing prolonged antibiotics as they can cause added gastrointestinal issues that can be chronic." The PARITY investigators work resulted in 13 manuscripts published in peer-reviewed journals, including The Journal of the American Medical Association (Oncology). Future Use of PARITY Data The PARITY database represents the highest quality of information on a massive scale on the treatment and outcomes of patients undergoing oncologic reconstruction surgery for bone tumors. PARITY investigators and their research team submitted research questions that could be answered through a secondary analysis of the database and a further 13 manuscripts were developed for a special supplement edition of the Journal of Bone and Joint Surgery. These studies look at such issues as patient and treatment risk factors for SSI and reoperation and the incidence and risk factors for thromboembolic events in lower extremity reconstruction. Additionally, the PARITY Writing Committee worked with the editors of JAMA Oncology to release the PARITY data to the public on Jan. 6, 2023, to further the dissemination of the study data. About the Kappa Delta Awards In 1947, at its golden anniversary, the Kappa Delta Sorority established the Kappa Delta Research Fellowship in Orthopaedics, the first award ever created to honor achievements in the field of orthopaedic research. The first annual award, a single stipend of $1,000, was made available to the AAOS in 1949 and presented at the AAOS meeting in 1950. The Kappa Delta Awards have been presented by the AAOS to persons who have performed research in orthopaedic surgery that is of high significance and impact. The sorority has since added two more awards and increased the award amounts to $20,000 each. Two awards are named for the sorority national past presidents who were instrumental in the creation of the awards: Elizabeth Winston Lanier, and Ann Doner Vaughn. The third is known as the Young Investigator Award. For more information about the manuscript submission process, please visit aaos.org/kappadelta. Learn more about the Kappa Delta Foundation, here. About the AAOS With more than 39,000 members, the American Academy of Orthopaedic Surgeons is the world's largest medical association of musculoskeletal specialists. The AAOS is the trusted leader in advancing musculoskeletal health. It provides the highest quality, most comprehensive education to help orthopaedic surgeons and allied health professionals at every career level to best treat patients in their daily practices. The AAOS is the source for information on bone and joint conditions, treatments and related musculoskeletal healthcare issues and it leads the healthcare discussion on advancing quality. Follow the AAOS on Facebook, Twitter, LinkedIn and Instagram. Disclosure Funding The PARITY Project was funded by the Canadian Institutes of Health Research, the Orthopaedic Research and Education Foundation in partnership with the Musculoskeletal Tumor Society, the Canadian Cancer Society Research Institute, Physicians Services Incorporated, the Canadian Orthopaedic Foundation, the Silverhearts Foundation, and the Hamilton Health Sciences New Investigator Fund. i Jeys L, Grimer R. 2009. The Long-Term Risks of Infection and Amputation with Limb Salvage Surgery Using Endoprostheses. In: Tunn P-U, editor. Treatment of Bone and Soft Tissue Sarcomas. Berlin, Heidelberg: Springer. p 75–84. Available from: . ii Mayo Clinic. Bone Cancer. Accessed 1/5/2023. URL: iii Morii T, Yabe H, Morioka H, et al. 2010. Postoperative deep infection in tumor endoprosthesis reconstruction around the knee. J Orthop Sci 15(3):331–339. iv Jeys LM, Grimer RJ, Carter SR, Tillman RM. 2003. Risk of amputation following limb salvage surgery with endoprosthetic replacement, in a consecutive series of 1261 patients. Int Orthop 27(3):160–163. v Akahane T, Shimizu T, Isobe K, et al. 2007. Evaluation of postoperative general quality of life for patients with osteosarcoma around the knee joint. J Pediatr Orthop B 16(4):269–272. vi Mullish BH, Williams HR. 2018. Clostridium difficile infection and antibiotic-associated diarrhea. Clin Med (Lond) 18(3):237–241. SOURCE American Academy of Orthopaedic Surgeons

ROSEMONT, Ill., Feb. 10, 2023 /PRNewswire/ -- The 2023 Kappa Delta Elizabeth Winston Lanier Award was presented to the Major Extremity Trauma Research Consortium (METRC) for its multi-disciplinary research platform addressing the challenging issues related to the evaluation, treatment and recovery after severe extremity trauma. This award recognizes research in musculoskeletal disease or injury with great potential to advance patient care. As the largest orthopaedic trauma research enterprise to date, METRC has conducted 34 studies, enrolled over 22,000 patients across 70 sites and published 57 papers, resulting in increased awareness and funding for extremity trauma care. Continue Reading The 2023 Kappa Delta Elizabeth Winston Lanier Award was presented to the Major Extremity Trauma Research Consortium for its multi-disciplinary research platform addressing the challenging issues related to the evaluation, treatment and recovery after severe extremity trauma. To read more about the award, please click here. Highlights from the Research During Operation Iraqi Freedom and Operation Enduring Freedom in Afghanistan, military orthopaedic surgeons were challenged with a surge of casualties with complex single or multiple extremity injures. While advanced field care and the use of body armor reduced combat mortality, it increased the injury burden to the unprotected extremities. Critical challenges surfaced, including complex wound management, infection, bone and articular surface loss, blast-related heterotopic ossification, segmental nerve injury, volumetric muscle loss, acute compartment syndrome (ACS) and severe psychological stress that can complicate long-term recovery. At the same time, surgeons at Level I trauma centers across the country were experiencing similar challenges for treating civilian patients with high energy traumas, such as severe leg injuries with open fractures, bone loss, muscle and nerve damage, heavy contamination and compartment syndrome. With lobbying support from the American Academy of Orthopaedic Surgeons (AAOS), the Department of Defense (DOD) requested proposals for an inaugural peer-reviewed consortium grant for Extremity War Injury research in 2008. Rather than submit competing applications, existing trauma research teams from the Lower Extremity Assessment Project (LEAP) study, the Southeast Fracture Consortium and the Orthopaedic Trauma Research Consortium worked together to develop an inclusive and unified approach, assembling top talent from around the country. As a result, METRC was formed, and in 2009 was awarded the DOD grant to establish a clinical research platform infrastructure and initiate prospective clinical research targeted to infection, ACS and bone healing. "By establishing a military-civilian research collaboration, investigators could translate learnings across sectors, research could continue during interwar periods and the research dollars could benefit from an economy of scale by sharing resources and reducing the cost per study, while increasing productivity," said Michael J. Bosse, MD, FAAOS, clinical chair emeritus of METRC. METRC was anchored by a Data Coordinating Center at the Johns Hopkins Bloomberg School of Public Health and initially engaged clinical investigators at 20 Level I trauma centers and the four major military treatment facilities. The success of the Consortium can be attributed to the following framework: Conducting randomized clinical trials and employing a "gaps driven" approach to define research that purposefully identifies challenging surgical and scientific questions Organizing a multi-center approach to conduct timely and clinically impactful research Developing a coordinated, standardized approach to protocol development and data collection Understanding that METRC's growth allows for the design and execution of large pragmatic trials Establishing quality assessment and improvement strategies to learn, evolve and improve from each study Supporting individual participating investigators and academic centers to receive extremity trauma research funding "We knew this initiative would not be successful unless we adopted a culture of collaboration among the researchers at our institutions," said Ellen J. MacKenzie, PhD, METRC founding director of the Coordinating Center. "We worked hard to develop processes that were engaging, made everybody feel included, gave everybody a voice and recognized the collective accomplishments of the team." METRC selected seven research areas that were thought to be of highest importance in both military and civilian high energy trauma patients. These included: Prevention and management of acute and chronic musculoskeletal infections Early acute management of orthopaedic injury Reconstruction surgery and nonsurgical management to improve bone healing Prediction, prevention and amelioration of secondary conditions and long-term physical health effects Management of pain and psychosocial sequelae Rehabilitation interventions to improve functional outcomes and quality of life Amputation and limb salvage outcomes including optimization of prosthetics and orthotic devices The Consortium's research findings include: The Prevent CLOT study, the largest of the METRC research efforts, enrolled over 12,000 patients and showed that low dose aspirin was non-inferior to low-molecular-weight heparin in preventing death and was associated with a low incidence of deep-vein thrombosis and pulmonary embolism in the care of trauma patients with operatively treated extremity fractures or with any pelvic or acetabular fractures.i The VANCO studyii,iii investigated an emerging low-cost topical wound antibiotic technique to reduce fracture-related infections by applying 1,000 mg of topical vancomycin to the wound prior to closure. The study demonstrated a 35% overall reduced risk of infection and a 50% reduction in gram positive infections. A study involving tobramycin targeting gram negative bacteria is currently underway. The Predicting Acute Compartment Syndrome studyiii sought to gain a better understanding of diagnostic standards for ACS, a challenging condition, as it is difficult to diagnose, can occur quickly and potentially lead to amputation or death. While more research is needed, in this study, near-infrared spectroscopy was unreliable for continuous measurement of tissue oxygenation in limbs with tibia fracturesiv and was not able to reliably identify early changes in tissue oxygenation in patients at risk for ACS. Additionally, using a novel approach of having an expert panel review each case to determine whether ACS was present, the research highlighted a high incidence of unnecessary surgery when using a currently accepted standard of care to determine when fasciotomy is necessary (a surgery that is done emergently to reduce muscle pressure to maintain blood flow)v. The OUTLET study provided further analysis of the 2002 LEAP study cohort, which originally found that limb salvage and amputation provided similar outcomes for severe high energy trauma below the distal femur. Following reports of disappointing results from the salvage attempts of those patients with a severely injured distal tibia, ankle and/or foot, the OUTLET study found that for a subset of those with severe and complex foot and ankle injuries, early amputation was associated with a better outcome than the limb salvage patientsvi. "Over the past decade, the Consortium has grown to over 400 investigators, and what's really impressive is the caliber of those who are involved," said Dr. Bosse. "They are the who's who in orthopaedic trauma in North America. Not only are they making game-changing discoveries, but they are training the next generation of residents, fellows and investigators, many of whom have gone on to start METRC-funded research centers." Since 2009, METRC has received $150 million in funding from the DOD, Patient Centered Outcomes Research Institute and National Institutes of Health. "The real advantage of the Consortium has been the ability to leverage our resources across studies, which otherwise couldn't have been conducted had it not been for the large multi-disciplinary team spanning numerous leading trauma centers across the country," said Dr. MacKenzie. "The funding has helped us maintain the infrastructure at the coordinating center and clinical sites to conduct this research, and a continued investment will not only advance the care of injured service members in future conflicts but contribute to the medical readiness of current forces." About the Kappa Delta Awards In 1947, at its golden anniversary, the Kappa Delta Sorority established the Kappa Delta Research Fellowship in Orthopaedics, the first award ever created to honor achievements in the field of orthopaedic research. The first annual award, a single stipend of $1,000, was made available to the AAOS in 1949 and presented at the AAOS meeting in 1950. The Kappa Delta Awards have been presented by the AAOS to persons who have performed research in orthopaedic surgery that is of high significance and impact. The sorority has since added two more awards and increased the award amounts to $20,000 each. Two awards are named for the sorority national past presidents who were instrumental in the creation of the awards: Elizabeth Winston Lanier, and Ann Doner Vaughn. The third is known as the Young Investigator Award. For more information about the manuscript submission process, please visit aaos.org/kappadelta. Learn more about the Kappa Delta Foundation, here. About the AAOS With more than 39,000 members, the American Academy of Orthopaedic Surgeons is the world's largest medical association of musculoskeletal specialists. The AAOS is the trusted leader in advancing musculoskeletal health. It provides the highest quality, most comprehensive education to help orthopaedic surgeons and allied health professionals at every career level to best treat patients in their daily practices. The AAOS is the source for information on bone and joint conditions, treatments and related musculoskeletal healthcare issues and it leads the healthcare discussion on advancing quality. Follow the AAOS on Facebook, Twitter, LinkedIn and Instagram. Disclosure Funding and Conflicts of Interest METRC has no conflicts of interests. METRC Grants, Award Numbers, Prime Award Recipients: DoD Consortium Award METRC 1, W81XWH-09-2-0108, Johns Hopkins Bloomberg School of Public Health METRC 2, W81XWH-10-2-0090, Johns Hopkins Bloomberg School of Public Health METRC 3, W81XWH-16-2-0060, Johns Hopkins Bloomberg School of Public Health DoD PRORP SEXTANT, W81XWH-19-2-0062, Carolinas Medical Center Stem Cell, W81XWH-18-2-0055, Johns Hopkins School of Medicine TOBRA, W81XWH-19-1-0848, University of Maryland UNION Biomarkers, W81XWH-19-1-0796, Boston Medical Center VANCO, W81XWH-10-2-0134, University of Maryland Weight Bearing, W81XWH-18-1-0810, Vanderbilt University Medical Center Mobility Tool Kit, W81XWH-18-1-0815, Carolinas Medical Center OXYGEN, W81XWH-12-1-0588, University of Maryland POvIV, W81XWH-10-2-0133, Vanderbilt University Medical Center POvIV II, TBD, Vanderbilt University Medical Center PACS II, W81XWH-20-2-0050, Hennepin County Medical Center PACS-PH, TBD, Hennepin County Medical Center METALS II, W81XWH-15-2-0058, Johns Hopkins Bloomberg School of Public Health NERVE, W81XWH-15-2-0074, Johns Hopkins School of Medicine ProFit; W81XWH-14-1-0563, University of California San Francisco PRIORITI – MTF, W81XWH-12-2-0032, Johns Hopkins Bloomberg School of Public Health REPAIR, W81XWH-15-2-0067, Johns Hopkins Bloomberg School of Public Health NSAIDS, W81XWH-20-2-0063, University of Utah DoD AFIRM Peg Fusion, W81XWH-20-1-0825, Johns Hopkins School of Medicine NIH-NIAMS STREAM, R01AR064066, Johns Hopkins Bloomberg School of Public Health PCORI Prevent Clot, PCS-1511-32745, University of Maryland School of Medicine i METRC. Aspirin or low-molecular-weight heparin for thromboprophylaxis after fracture. N Engl J Med 2023;388:203-13. ii Bosse, M.J., MacKenzie, E.J., Pollak, A.N., Stinner, D.J. (Eds). 2017. The Major Extremity Trauma Research Consortium. [Special Issue]. J Orthop Trauma. 31(4). iii METRC. 2021. Effect of Intrawound Vancomycin Powder in Operatively Treated High- risk Tibia Fractures: A Randomized Clinical Trial. JAMA Surgery. 156(5):e207259- e207259. iv Schmidt AH, Bosse MJ, Obremskey WT, et al. 2018. Continuous near-infrared spectroscopy demonstrates limitations in monitoring the development of acute compartment syndrome in patients with leg injuries. J Bone Joint Surg Am. 100(19):1645-1652. v Schmidt AH, Di J, Zipunnikov V, et al. 2020. Perfusion pressure lacks diagnostic specificity for the diagnosis of acute compartment syndrome. J Orthop Trauma. 34(6):287-293. vi METRC. 2021. Outcomes Following Severe Distal Tibial, Ankle, and/or Mid/Hindfoot Trauma: comparison of limb salvage and transtibial amputation (OUTLET). J Bone Joint Surg Am. 103(17):1588-1597. SOURCE American Academy of Orthopaedic Surgeons