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Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_2 | Pages 54 - 54
10 Feb 2023
Lewis D Tarrant S Dewar D Balogh Z
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Prosthetic joint infections (PJI) are devastating complications. Our knowledge on hip fractureassociated hemiarthroplasty PJI (HHA-PJI) is limited compared to elective arthroplasty. The goal of this study was to describe the epidemiology, risk factors, management, and outcomes for HHA-PJI. A population-based (465,000) multicentre retrospective analysis of HHAs between 2006-2018 was conducted. PJI was defined by international consensus and treatment success as no return to theatre and survival to 90 days after the initial surgical management of the infection. Univariate, survival and competing risk regression analyses were performed. 1852 HHAs were identified (74% female; age:84±7yrs;90-day-mortality:16.7%). Forty-three (2.3%) patients developed PJI [77±10yrs; 56% female; 90-day-mortality: 20.9%, Hazard-Ratio 1.6 95%CI 1.1-2.3,p=0.023]. The incidence of HHA-PJI was 0.77/100,000/year and 193/100,000/year for HHA. The median time to PJI was 26 (IQR 20-97) days with 53% polymicrobial growth and 41% multi-drug resistant organisms (MDRO). Competing risk regression identified younger age [Sub-Hazard-Ratio(SHR) 0.86, 95%CI 0.8-0.92,p<0.001], chronic kidney disease (SHR 3.41 95%CI 1.36-8.56, p=0.01), body mass index>35 (SHR 6.81, 95%CI 2.25-20.65, p<0.001), urinary tract infection (SHR 1.89, 95%CI 1.02-3.5, p=0.04) and dementia (SHR 9.4, 95%CI 2.89-30.58,p<0.001) as significant risk factors for developing HHA-PJI. When infection treatment was successful (n=15, 38%), median survival was 1632 days (IQR 829-2084), as opposed to 215 days (IQR 20-1245) in those who failed, with a 90-day mortality of 30%(n=12). There was no significant difference in success among debridement, excision arthroplasty or revision arthroplasty. HHA PJI is uncommon but highly lethal. All currently identified predictors are non-modifiable. Due to the common polymicrobial and MDRO infections our standard antibiotic prophylaxis may not be adequate HHA-PJI is a different disease compared to elective PJI with distinct epidemiology, pathogens, risk factors and outcomes, which require targeted research specific to this unique population


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_4 | Pages 137 - 137
1 Feb 2017
Sikora-Klak J Markel D Bergum C
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Background. The ability to identify those at risk for longer inpatient stay helps providers with postoperative planning and patient expectations. Decreasing length of stay in the future will be determined by appropriate patient selection, risk stratification, and pre-operative patient optimization. The purpose of this study was to identify factors that place patients at risk for extended postoperative lengths of stay. Methods. The prospective study cohort included 2009 primary total knee arthroplasty (TKA) patients and 905 total hip arthroplasty (THA) patients. Patient comorbidities were prospectively identified and the length of stay for each patient was tracked following a primary arthroplasty. Statistical analysis was performed to correlate which comorbidities were associated with longer inpatient stays. Results. In the TKA population, gender, smoking status, venous thromboembolism history, body mass index and diabetes status were not found to be a significant predictors for length of stay. Age was found to be a factor in univariate regression testing (P<0.001). In the THA population, univariate testing showed female gender (P<0.001), smoking status (P=0.002), and age (p<0.001) to be factors, but like the TKA population venous thromboembolism history or diabetes status were not significant. In THA multivariate analysis, age (p<0.001) and female gender (p=0.018) continued to be factors, but smoking was determined to be a confounding variable. Conclusions. Age and gender were associated with a longer length of stay after THA, whereas only age was a significant factor after TKA. Development of age adjusted LOS models may help aid patient expectations and risk management


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_9 | Pages 78 - 78
1 May 2016
Narayan V
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The ATTUNE™ Knee System (DePuy Synthes) comprises of a tibial insert that is made from AOX™, an antioxidant-stabilized polyethylene. The antioxidant used in AOX is pentaerythritol tetrakis [3-(3, 5-di-tertiary butyl-4-hydroxyphenyl)] propionate (PBHP). A biological risk assessment of the degradation products arising from PBHP has been performed. This assessment focuses on the requirements of ISO 10993–1:2009, ISO 14971:2007, and the Medical Device Directive 93/42/EEC. Because the orthopedic implant is a permanent implant, consideration has been given to all relevant endpoints defined by ISO 10993–1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process. Comprehensive biocompatibility testing including long-term (26 weeks) subcutaneous implantation has been conducted which confirms the biosafety of the polyethylene compound[1]. In addition to the biological safety testing completed, the overall safety and the associated toxicological risk of exposure to degradation products of PBHP has been given due consideration. The guidelines for the Threshold for Toxicological Concern (TTC) provided by The Product Quality Research Institute (PQRI) Leachables and Extractables Working Group were used in the assessment[2]. This working group is a collaboration of chemists and toxicologists from the U.S. Food and Drug Administration (FDA), industry, and academia. The TTC principle allows safety assessment in the absence of substance-specific hazard data, based on very low levels of exposure to that substance. A Margin of Safety (MOS) is calculated as the ratio of the threshold safety value to the actual exposure quantities determined and used in the assessment. A MOS value greater than 1 is typically judged by risk assessors and regulatory bodies to be unlikely to cause harm and the risk may be considered low. The identity of the degradation products as well as the corresponding 30-day leachable quantities from a water:acetone extraction media has been previously reported [3] and provided here (Table 1). The amount of leachables determined from Table 1 for all products were well below the TTC of 150 ng/device and hence no toxicological risks were identified for these compounds. In order to further examine the toxicological risk assessment, aggressive extraction using Dynamic Head Space (DHS) extraction was done and analytical testing was performed on the degradation products of PBHP using gas chromatography/mass spectrometry (GC /MS). These estimated quantities along with literature information from biological safety studies of the chemicals that were identified from the quantitative GC/MS analysis of degradation products of PBHP were used in the review and toxicological assessment per the methodology described in ISO 14971 and ISO 10993–18. The extraction and analysis confirmed the same sixteen compounds previously identified. The quantities and the calculated margins of safety are summarized (Table 2). In conclusion, upon review of actual test results of PBHP degradation products (Table 1), there is little probability that these organic degradation products would cause a systemic reaction and not be safe. Thus, the potential biological hazards identified in ISO 10993–1:2009 due to the quantified leachables have been verified to be minimal with a high Margin of Safety relative to the Threshold of Toxicological Concern


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXIII | Pages 12 - 12
1 May 2012
Dixon D
Full Access

This fiducial role implies special duties imposed where one person (the fiduciary) must act in the best interest of the other (the beneficiary), even if it is in the fiduciary's detriment to do so. While a doctor/patient relationship is not generally a fiduciary relationship, part of the relationship may involve a fiduciary role for the surgeon. The fiduciary duties include:. Keeping a patient's medical information confidential. Open disclosure of surgical error. Notification of an emergent medical risk to the patient. Avoiding gifts from patients not freely given. Avoiding conflict of interest in implant selection. Disclosing financial involvement with healthcare facility. Candour when a known risk has materialised. E.g. implant failure. Share crucial information with patients to mitigate potential harm. Follow up until the treatment period is over with relevant information. Limit therapeutic privilege as grounds for non-disclosure. Follow the Association's guidelines on product endorsement. New procedures may require ethics approved clinical trials. Avoid personal relationships with patients. While the doctor–patient relationship requires a duty of care, a fiduciary duty implies a duty of loyalty and honesty. As per using navigation techniques in hip and knee surgery, the surgeon can use the above fiducials (markers) to navigate his way through his fiduciary role in managing patients; whether it is disclosing emergent risks arising during treatment, with new products or during clinical trials. Fiduciary roles are independent of informed consent, which occurs before the event, but mitigate a risk that occurs after the event. It is an inbuilt quality assurance mechanism in risk management


Bone & Joint Open
Vol. 1, Issue 3 | Pages 41 - 46
18 Mar 2020
Perry DC Arch B Appelbe D Francis P Spowart C Knight M

Introduction

There is widespread variation in the management of rare orthopaedic disease, in a large part owing to uncertainty. No individual surgeon or hospital is typically equipped to amass sufficient numbers of cases to draw robust conclusions from the information available to them. The programme of research will establish the British Orthopaedic Surgery Surveillance (BOSS) Study; a nationwide reporting structure for rare disease in orthopaedic surgery.

Methods

The BOSS Study is a series of nationwide observational cohort studies of pre-specified orthopaedic disease. All relevant hospitals treating the disease are invited to contribute anonymised case details. Data will be collected digitally through REDCap, with an additional bespoke software solution used to regularly confirm case ascertainment, prompt follow-up reminders and identify potential missing cases from external sources of information (i.e. national administrative data). With their consent, patients will be invited to enrich the data collected by supplementing anonymised case data with patient reported outcomes.

The study will primarily seek to calculate the incidence of the rare diseases under investigation, with 95% confidence intervals. Descriptive statistics will be used to describe the case mix, treatment variations and outcomes. Inferential statistical analysis may be used to analyze associations between presentation factors and outcomes. Types of analyses will be contingent on the disease under investigation.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_29 | Pages 40 - 40
1 Aug 2013
Firth G Moroz P Kingwell S
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Purpose:. Non-contiguous spinal injury can add significant complexity to the diagnosis, management and outcome in children. There is very little in the paediatric literature examining the nature, associated risk factors, management and outcomes of non-contiguous spinal injuries. The objective is to determine the incidence and clinical characteristics of non-contiguous spinal injuries in a paediatric population. The secondary objective is to identify high risk patients requiring further imaging to rule out non-contiguous spinal injuries. Methods:. All children up to 18 years of age with a spinal injury, as defined by ICD-09 codes at one paediatric trauma hospital were included (n=211). Data for patient demographics, mechanism of injury, spinal levels involved, extent of neurologic injury and recovery, associated injuries, medical complications, treatment and outcome were recorded. Results:. Twenty five (11.8%) out of 211 patients had non-contiguous spinal injuries. The mean age was 10.7 years. The most common pattern of injury was a double thoracic non-contiguous injury. 16% of cases of NCSI were initially missed, but with no clinical deterioration due to the missed diagnosis. Associated injuries occurred in 52% of patients with NCSI. Twenty-four percent of patients with multiple non-contiguous spinal injuries had a neurologic injury compared to 9.7% in patients with single level or contiguous injuries (p=0.046). Conclusions:. There is a high incidence of children with multiple non-contiguous spinal injuries who are more likely to suffer neurological injuries compared to patients with single level or contiguous spinal injuries. Patients with a single level spinal injury on existing imaging and a neurological injury should have entire spine lateral radiographs to exclude non-contiguous injuries. In patients without neurologic injury and a single spinal fracture, radiographs showing at least 7 levels above and below the fracture should be performed. All children with spinal injury should have associated injuries carefully excluded


Bone & Joint Research
Vol. 3, Issue 7 | Pages 223 - 229
1 Jul 2014
Fleiter N Walter G Bösebeck H Vogt S Büchner H Hirschberger W Hoffmann R

Objective

A clinical investigation into a new bone void filler is giving first data on systemic and local exposure to the anti-infective substance after implantation.

Method

A total of 20 patients with post-traumatic/post-operative bone infections were enrolled in this open-label, prospective study. After radical surgical debridement, the bone cavity was filled with this material. The 21-day hospitalisation phase included determination of gentamicin concentrations in plasma, urine and wound exudate, assessment of wound healing, infection parameters, implant resorption, laboratory parameters, and adverse event monitoring. The follow-up period was six months.


The Journal of Bone & Joint Surgery British Volume
Vol. 88-B, Issue 7 | Pages 943 - 948
1 Jul 2006
Phillips JE Crane TP Noy M Elliott TSJ Grimer RJ

The Control of Infection Committee at a specialist orthopaedic hospital prospectively collected data on all episodes of bacteriologically-proven deep infection arising after primary hip and knee replacements over a 15-year period from 1987 to 2001.

There were 10 735 patients who underwent primary hip or knee replacement. In 34 of 5947 hip replacements (0.57%) and 41 of 4788 knee replacements (0.86%) a deep infection developed. The most common infecting micro-organism was coagulase-negative staphylococcus, followed by Staphylococcus aureus, enterococci and streptococci. Of the infecting organisms, 72% were sensitive to routine prophylactic antimicrobial agents.

Of the infections, 29% (22) arose in the first three months following surgery, 35% between three months and one year (26), and 36% (27) after one year. Most cases were detected early and treated aggressively, with eradication of the infection in 96% (72). There was no significant change in the infection rate or type of infecting micro-organism over the course of this study.

These results set a benchmark, and importantly emphasise that only 64% of peri-prosthetic infections arise within one year of surgery. These results also illustrate the advantages of conducting joint replacement surgery in the isolation of a specialist hospital.