While indications for total knee (TKA) and hip arthroplasty (THA) have expanded over the last 35 years, implant labeling has largely remained stagnant, with conditions including obesity, developmental dysplasia, and many others (Table 1) still considered as contraindications. Implant labeling has not co-evolved with surgical indications, as most orthopaedic implants are cleared through the 510(k) process, which conserves the labeling of the predicate device. While surgeons can legally use devices for off-label indications, the scrutiny regarding off-label use of orthopaedic implants has intensified. The objective of this study was to determine the incidence of off-label use at our institution, define the risk in terms of revision rate associated with off-label use, and to compare activity level, functional outcomes, and general health outcomes for on- and off-label TKA and THA patients. Patients who underwent primary TKA or THA at a large academic tertiary referral center between January 1, 2010 and June 30, 2010 were considered for the study (n = 705). Of this cohort, a convenience sample of 283 patients were selected for the study based on the presence of baseline outcomes data. Patients were contacted via mail and/or phone to collect details regarding potential revision surgeries, UCLA activity scores, short form-12 (SF-12), Knee Injury and Osteoarthritis Outcome Score (KOOS) or Hip Disability and Osteoarthritis Outcome Score (HOOS). Using labeled contraindications from the product inserts from multiple orthopaedic implant manufacturers, procedures were categorized as on-label or off-label. Outcomes including revision rate, activity score, and SF-12, KOOS, and HOOS scores were adjusted for age, gender, and BMI by fitting a logistic model and analyzed using the Wald chi-square test (SPSS, Chicago, IL).Introduction:
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Primary total knee arthroplasty (TKA) is associated with perioperative bleeding, and some patients will require allogenic blood transfusion during their inpatient admission. While blood safety has improved in the last several decades, blood transfusion still carries significant complications and costs. Transfusion indications and alternative methods of blood conservation are being explored. However, there is limited nationally representative data on allogenic blood product utilization among TKA patients, and its associated outcomes and financial burden. The purpose of this study was to use a national administrative database to investigate the trends in utilization and outcomes (i.e. in-hospital mortality, length of stay, admission costs, acute complications) of allogenic blood transfusion in primary TKA patients. The Nationwide Inpatient Sample (NIS), the largest all-payer inpatient care database representing a 20% stratified sample of United States hospitals, was utilized. Primary TKA (ICD-9-CM 81.54) cases from 2000 to 2009 were retrospectively queried (n = 4,544,999; weighted national frequency). A total of 67,841 admissions were excluded (Figure 1). The remaining 4,477,158 cases were separated into two study cohorts: (1) patients transfused with allogenic blood products (red blood cells, platelets, serum) (n = 540,270) and (2) patients not transfused (n = 3,936,888). Multivariable regression and generalized estimating equations were used to examine the effect of transfusion on outcomes, adjusting for patient/hospital characteristics and comorbidity.Introduction:
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Multimodal analgesia protocols for pain control following total joint arthroplasty can reduce post-operative pain, allow early mobilisation and early discharge from hospital. This study analyses the achievement of functional milestones, patient satisfaction, length of stay and adverse outcomes using a multimodal analgesia protocol in total joint arthroplasty. All patients planned for elective hip and knee arthroplasty in a NSW teaching hospital under one surgeon between July 2007 and January 2009 were included in this prospective study. Patients undergoing revision surgery, bilateral arthroplasty or total hip arthroplasty for fractures were excluded. Unless contraindicated, all patients followed the multimodal analgesia protocol based on the local infiltration analgesia technique described by Kerr and Kohan. Patient demographics, post operation milestones, visual analogue pain scores (VAS), narcotic consumption, length of stay, discharge destination, patient satisfaction scores and adverse outcomes. Nineteen patients (13 female and 6 male) with an average age 67 years and BMI 33 had total hip arthroplasty surgery. 84% (16/19) ambulated within six hours post operation. 47% (9/19) of patients were discharged home by day 3 post operation (1/19 on day 1, 5/19 on day 2, 3/19 on day 3). Average day post operation for discharge home was 4.5 days. Thirty-one patients (17 female and 14 male) with an average age 68 years and BMI 33 had total knee arthroplasty surgery. 90% (28/31) ambulated within six hours after surgery. 71% (22/31) of patients were discharged home by day three post operation (6/31 on day 1, 8/31 on day 2 and 8/31 on day 3). Average day post operation for discharge home was four days. Ten patients required morphine in addition to protocol analgesia. VAS scores (1 to 10) averaged 3.2 day one post op and 2.6 prior to discharge. Three patients developed nausea and vomiting and one patient developed urinary retention. No infections, DVTs or other adverse effects occurred in either hip or knee arthroplasty groups. Majority of patients were very satisfied according to 24 hour post op pain management survey and six week post op patient satisfaction survey. Local infiltration analgesia in knee and hip arthroplasty surgery is a safe, well-tolerated and effective form of pain control allowing early mobilisation and early discharge from hospital (1,2). This protocol has been successfully implemented in a public hospital.Outcomes measurements included
Published data has shown that only 45% of acetabular components were in an acceptable position, where positioning was determined clinically by the surgeon intra-operatively. The aim of this study is to assess the accuracy of cup orientation, using computer tomography (CT), when the TAL is used as the intra-operative guide. In this prospective study, the TAL was used as the anatomical reference for positioning the cup. The TAL was graded 1 to 4 based on visibility of the ligament. The version and abduction angles were estimated clinically and recorded by the surgeon after insertion of the cup. Post-operatively the true orientation of the cup was measured using CT. Statistical analyses were carried out to calculate the difference between the intra-operative estimation of cup orientation and the true cup position as measured by CT. Ethical approval was granted and informed consent was obtained for all the patients. Forty-eight hips have been studied to date. The TAL was easily identifiable in the majority of cases. Overall, the cup version was under-estimated by the surgeon when the TAL was utilized as the anatomical landmark. The true mean acetabular component version was 26.5 degrees [range from 11 to 41 degrees]. The true mean abduction angle was 43.6 degrees [range from 35 to 55 degrees]. The mean difference between surgeon estimation and CT measurement for cup version was 4 degrees of underestimation [range from 14 degrees of underestimation to 11 degrees of overestimation]. The mean difference for abduction angle was 0.1 degrees [range from 14 degrees of underestimation to 10 degrees of overestimation]. When using TAL as an intra-operative guide, 64% of acetabular components were within the target range of 15 to 30 degrees of anteversion, as measured by CT, compared to 45% in previously published study (Wines, A &
McNicol, D, J. Arthroplasty, 2006). TAL improves the accuracy of acetabular component version, when utilized as an anatomical landmark during cup insertion in primary total hip arthroplasty. It is reliable and easily identifiable in the majority of cases.
Current orthopaedic practice involves an increasing use of operative fluoroscopic screening and radiation exposure. The AOA produces a booklet entitled “Radiation safety for orthopaedic surgeons” outlining the risks. There is a disparity between guidelines and actual clinical practice for trainee registrars.
To measure trainee fluoroscopy usage with and without consultants present. To audit trainees and hospitals adherence to the guidelines All procedures in a 6 month period using II were analysed. Data for Procedure, Operating Surgeon, First Assistant and if Consultant Surgeon was present or absent was collected. Fluoroscopic Exposure Time was also recorded. Procedures were grouped and times compared depending on the staff present. There were 121 cases included in the study. 44 cases were performed by the trainee with the consultant assisting and 76 were performed in the absence of the consultant. A questionnaire based on the AOA guidelines was produced. All NSW advanced trainees in Orthopaedic surgery were asked to complete the anonymous questionnaire. There was a significant difference of 32.18 seconds in mean exposure time per case with a p-value 0.0069 where the consultant was present or not. There was also a significant difference between consultants doing the same cases. Other very significant findings were:
97% of trainees were not aware of the maintenance and inspection schedules equipment. 97% of trainees have practiced the incorrect technique of using the image receptor of the II machine as an operating table which maximizes scatter to the head and neck 65% regularly use continuous screening of II 65% admit to taking unnecessary II shots to ensure the perfect xray. 32% of trainees wore no thyroid protection, 87% no eye protection and 100% used no head and hand protection. One registrar was exposed to 8131 seconds of II exposure during his 6 month rotation. Without the use of lead protection, the trainee registrar will have exceeded the annual limit of whole body exposure (20mSv/year) by more than 2-fold. Dramatic decreases in exposure can be achieved by better discipline with the usage of II. This needs to be a fundamental part of registrar training. The survey shows trainees are not aware, or fail to adhere to current guidelines and that hospitals are not providing appropriate safety equipment and not insisting that staff exercise safe practices.
