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The Bone & Joint Journal
Vol. 100-B, Issue 9 | Pages 1253 - 1259
1 Sep 2018
Seewoonarain S Johnson AA Barrett M

Aims. Informed patient consent is a legal prerequisite endorsed by multiple regulatory institutions including the Royal College of Surgeons and the General Medical Council. It is also recommended that the provision of written information is available and may take the form of a Patient Information Leaflet (PIL) with multiple PILs available from leading orthopaedic institutions. PILs may empower the patient, improve compliance, and improve the patient experience. The national reading age in the United Kingdom is less than 12 years and therefore PILs should be written at a readability level not exceeding 12 years old. We aim to assess the readability of PILs currently provided by United Kingdom orthopaedic institutions. Patients and Methods. The readability of PILs on 58 common conditions provided by seven leading orthopaedic associations in January 2017, including the British Orthopaedic Association, British Hip Society, and the British Association of Spinal Surgeons, was assessed. All text in each PIL was analyzed using readability scores including the Flesch–Kincaid Grade Level (FKGL) and the Simple Measure of Gobbledygook (SMOG) test. Results. The mean FKGL was 10.4 (6.7 to 17.0), indicating a mean reading age of 15 years. The mean SMOG score was 12.8 (9.7 to 17.9) indicating a mean reading age of 17 years. Conclusion. Orthopaedic-related PILs do not comply with the recommended reading age, with some requiring graduate-level reading ability. Patients do not have access to appropriate orthopaedic-related PILs. Current publicly available PILs require further review to promote patient education and informed consent. Cite this article: Bone Joint J 2018;100-B:1253–9


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_3 | Pages 81 - 81
23 Feb 2023
Bolam S Munro L Wright M
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The purpose of this study was (1) to evaluate the adequacy of informed consent documentation in the trauma setting for distal radius fracture surgery compared with the elective setting for total knee arthroplasty (TKA) at a large public hospital and (2) to explore the relevant guidelines in New Zealand relating to consent documentation. Consecutive adult patients (≥16 years) undergoing operations for distal radius fractures and elective TKA over a 12-month period in a single-centre were retrospectively identified. All medical records were reviewed for the risks and complications recorded. The consent form was analysed using the Flesch Reading Ease Score (FRES) and the Simple Measure of Gobbledygook (SMOG) index readability scores. A total of 133 patients undergoing 134 operations for 135 distal radius fractures and 239 patients undergoing 247 TKA were included. Specific risks of surgery were recorded significantly less frequently for distal radius fractures than TKA (43.3% versus 78.5%, P < 0.001). Significantly fewer risks were recorded in the trauma setting compared to the elective (2.35 ± 2.98 versus 4.95 ± 3.33, P < 0.001). The readability of the consent form was 40.5 using the FRES and 10.9 using the SMOG index, indicating a university undergraduate level of reading. This study has shown poor compliance in documenting risks of surgery during the informed consent process in an acute trauma setting compared to elective arthroplasty. Institutions must prioritise improving documentation of informed consent for orthopaedic trauma patients to ensure a patient-centred approach to healthcare


The Bone & Joint Journal
Vol. 97-B, Issue 9 | Pages 1159 - 1161
1 Sep 2015
Foy MA

A recent Supreme Court ruling in the United Kingdom has significantly altered the emphasis of informed consent, moving from a historically ‘doctor-focused’ to a more ‘patient-focused’ approach, in line with the situation in other international jurisdictions. . The reasons for the change are discussed with some recommendations about how our attitudes need to change in the future. Cite this article: Bone Joint J 2015;97-B:1159–61


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_11 | Pages 52 - 52
1 Nov 2022
Harvey J Sheokand A Rambani R
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Abstract. Introduction. The risk of Covid-19 community and hospital acquired infection (HAI) on patient outcomes in trauma is still relevant. Patient's should be routinely consented for this risk to ensure informed consent for perioperative contraction. Method. A prospective audit was completed from December-March 2022 examining a consecutive series of patient admissions with capacity to consent. The standards for compliance was RCOS Toolkit 5#3 stating the importance of enhanced consent for risk of contraction, in operating and changes to care pathways. The target was 95% compliance. 2/2 contingency tables were generated to determine odds ratio for compliance versus Covid+ rate. Results. This audit generated 80 consecutive patients from which 28 were excluded as non-operative or lacking capacity. It was found that 25% (13/52) had been specifically consented for risks of Covid-19. The rate of PCR-positive results was 15% (8/52) with a mortality of 25%. Approximately 2% of patients in this series were informed of the risk and had a positive Covid-PCR. An odds ratio of 0.38 indicates that being informed of the risk is not associated with rate of infection e.g by adopting enhanced personal protective measures. Conclusions. The pandemic recovery has not removed this substantial community and nosocomial risk. Our results demonstrate poor compliance with RCS guidance despite ongoing relevance to care. Consent includes the counselling of a patient to specific Covid-related risks including thrombosis & death. Dissemination of these results will be followed by completion of the audit cycle to look for improvements in compliance


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_6 | Pages 108 - 108
1 Jul 2020
Chang J Bhanot K Grant S Fecteau A Camp M
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The process of obtaining informed consent is an important and complex pursuit, especially within a paediatric setting. Medical governing bodies have stated that the role of the trainee surgeon must be explained to patients and their families during the consent process. Despite this, attitudes and practices of surgeons and their trainees regarding disclosure of the trainee's participation during the consent process has not been reported in the paediatric setting. Nineteen face-to-face interviews were conducted with surgical trainees and staff surgeons at a tertiary level paediatric hospital in Toronto, Canada. These were transcribed and subsequently thematically coded by three reviewers. Five main themes were identified from the interviews. 1) Surgeons do not consistently disclose the role of surgical trainees to parents. 2) Surgical trainees are purposefully vague in disclosing their role during the consent discussion without being misleading. 3) Surgeons and surgical trainees believe parents do not fully understand the specific role of surgical trainees. 4) Graduated responsibility is an important aspect of training surgeons. 5) Surgeons feel a responsibility towards both their patients and their trainees. Surgeons don't explicitly inform patients about the involvement of trainees, believing there is a lack of understanding of the training process. Trainee perspectives reflect this, with the view that families are aware of their participation but likely underestimate their role, and suggest that information is kept purposely vague to reduce anxiety. The majority of surgeons and surgical trainees do not voluntarily disclose the degree of trainee participation in surgery during the informed consent discussion with parents. An open and honest discussion should occur, allowing for parents to make an informed decision regarding their child's care. Further patient education regarding trainees' roles would help develop a more thorough and patient centred informed consent process


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXIX | Pages 252 - 252
1 Sep 2012
Morgan A Lee P Batra S Alderman P
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Background. Despite studies into patient consent and their understanding of the potential risks of trauma surgery, no study has looked at the patient's understanding of the procedure involved with neck of femur fracture surgery. Method. Prospective analysis of 150 patients who had operative fixation of neck of femur fractures in a district general hospital. Patients were asked on the third post-operative day to select which procedure they had undergone from a diagram of four different neck of femur surgeries (cannulated screws, cephalomedullary nail, dynamic hip screw and hemiarthroplasty). Exclusion criteria for patient selection - mini mental score of < 20 and confusion secondary to delirium. Results. All patients had signed consent form 1 which was matched to the procedure. All patients were consented by an FP2, CT1 or other SHO. The mean age of patients was 83years. 5% had cannulated screw fixation, 45% had a hemiarthroplasty, 42% had a dynamic hip screw and 8% had a cephalomedullary nail. 47% of patients could correctly identify the procedure they had undergone on the 3. rd. post-operative day. Conclusions. This study shows that there are questions about the effectiveness of informed consent and patient understanding of the procedure before and after hip fracture surgery. We suggest that further detailed studies may highlight the need for alternative ways of communicating procedures to the patients or that more specialised training is required for those explaining hip fracture surgery to patients. Improvements in these areas might help ensure the true informed consent required


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_15 | Pages 65 - 65
7 Nov 2023
Mukiibi W Aden A Iqbal N
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Surgeons must explain the risk of complications to prospective patients and get informed consent. If a complication that occurred was omitted in the process or given the wrong risk level, culpability of the surgeon is judged in court against what a “reasonable patient” would like to know to give or refuse consent. ObjectivesThe concept “reasonable patient” is widely used, no attempt has been made to define it objectively. We assessed insight of patients, presumed “reasonable”, about risks of certain complications after they underwent one of five orthopaedic procedures. Questionnaire was administered with procedures: femur IMN, tibia IMN, ankle ORIF, distal radius ORIF and hip arthroplasty. Four common/serious complications were chosen per procedure, and matched against life events with documented risk levels. There were 230 participants 163 males and 67 females. We found 19.1% of patients above age 40 and 33.3% with tertiary education wouldn't accept nerve injury as reported in literature. With infection risk, 18.1% above 40 and 52.9% with pre-tertiary education would not accept. All patients below 40 and 7.4% pre-tertiary education wouldn't accept the risk of death as reported. However, 37.1% above 40 and 76.9% with pre-tertiary education would accept that risk at a higher level. It is hard to predict what risk of complication a patient may accept. This study highlights that some patients will not accept risks as reported in literature, even though they need the procedure. Therefore, surgeons need to explain complications fully, so that patients knowingly accepts or refuses consent. The subset of patients who are not willing to accept any level of risk, should be the subject of another study


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_5 | Pages 22 - 22
1 Mar 2014
Kassam A Davis J
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Foot and ankle surgery is a rapidly evolving specialty. As the number and complexity of cases increases, the number of complaints, litigation and pay-outs has also risen. We aim to assess any learning points discerned from NHS litigation data to allow us help improve patient care. All claims made to the NHS Litigation Authority between 2007 and 2012 relating to foot and ankle problems were obtained under the Freedom of Information Act. These were reviewed, coded and split into subgroups to allow analysis. There were 232 successful litigation cases between 2007 and 2012. The total amount paid out was almost £18.5 million (range £112 to £1.6 million). A significant number of successful cases were due to patients not having full, informed consent. A large amount of money is spent in the NHS is spent on litigation. The amount of litigation and payout in foot and ankle surgery compares favourably with hip and knee surgery. Lack of informed consent is an easily reversible problem that should be decreasing but is actually on the rise. In our trust, we advocate the use of consent clinics which provide a robust and patient-centred approach to informed consent in foot and ankle surgery


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_19 | Pages 53 - 53
22 Nov 2024
Wallander K Beijer G Eliasson E Giske C Ponzer S Söderquist B Eriksen J
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Aim. Swedish guidelines on antibiotic prophylaxis in arthroplasty surgery recommend cloxacillin in fixed doses that pay little attention to the patient's renal function and weight. Nevertheless, there are no studies on whether the resulting free prophylactic cloxacillin in vivo concentrations are optimal. We aimed to evaluate whether the current recommended prophylactic dosage of cloxacillin is adequate. Method. We performed a prospective two-centre study, measuring the free (active) cloxacillin concentrations in plasma throughout surgery, in patients subject to primary hip and knee prosthetic joint replacements, aiming at 100 patients per centre. To account for plasma-bone exposure differences, concentrations were considered adequate if twice the epidemiological cut-off value for cloxacillin concerning wild type Staphylococcus aureus whereas two-three times were labelled threshold values. The two enrolling hospitals are acute care hospitals in central Sweden, also performing 600 - 1200 primary hip and knee joint arthroplasties annually. All patients scheduled for elective primary hip or knee replacements from January 2022 to April 2024 were eligible for participation. Exclusion criteria were allergy towards penicillins, cognitive disorders leading to inability to sign informed consent, and an absence of interpreter in case of a patient not speaking Swedish or English. Results. We present results from the first 49 patients included. Four patients had free cloxacillin concentrations below cut-off (8.2%). These four cases had prolonged surgeries of 77-100 minutes. An additional 5/49 (10.2%) had threshold values. Conversely 5/49 (10.2%) cases had concentrations exceeding 15 times the needed. No cases with threshold or low cloxacillin concentrations were attributable to a lack of concerning timing and dosing of cloxacillin. All concentrations were above or equal to our cut-off at the start of surgery. Eighteen percent of patients were of normal of weight (BMI 18.5- 25). Of the rest 4% were morbidly obese (BMI >40), 41% obese (BMI 30-40) and 37% overweight (BMI 25-30). Twenty seven percent (43/159) had diabetes and 45% suffered cardiac disease. Conclusions. Some patients in our cohort had insufficient active cloxacillin levels at the end of prosthetic joint surgery. Previous studies indicate that insufficient prophylactic antibiotic concentrations might lead to an enhanced risk of prosthetic joint infections. Other patients were massively overdosed, leading to unnecessary ecological effects and potentially adverse reactions. As inadequate cloxacillin concentrations were not associated with a lack of compliance to current guidelines a change in practise might be needed. Our final results may help to determine how dosing should be adjusted


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_5 | Pages 5 - 5
23 Apr 2024
Sain B Sidharthan S Naique S
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Introduction. Treatment of non-union in open tibial fractures Gustilo-Anderson(GA)-3A/3B fractures remains a challenging problem. Most of these can be dealt using treatment methods that requires excision of the non-union followed by bone grafting, masquelet technique, or acute shortening. Circular fixators with closed distraction or bone transport also remains a useful option. However, sometimes due to patient specific factors these cannot be used. Recently antibiotic loaded bone substitutes have been increasingly used for repairing infected non-unions. They provide local antibiotic delivery, fill dead space, and act as a bone conductive implant, which is resorted at the end of a few months. We aimed to assess the outcome of percutaneous injection of bone substitute while treating non-union of complex open tibial fractures. Materials & Methods. Three cases of clinical and radiological stiff tibial non-union requiring further intervention were identified from our major trauma open fracture database. Two GA-3B cases, treated with a circular frame developed fracture-related-infection(FRI) manifesting as local cellulitis, loosened infected wires/pins with raised blood-markers, and one case of GA-3A treated with an intramedullary nail. At the time of removal of metalwork/frame, informed consent was obtained and Cerament-G. TM. (bone-substitute with gentamicin) was percutaneously injected through a small cortical window using a bone biopsy(Jamshedi needle). All patients were allowed to weight bear as tolerated in a well-fitting air-cast boot and using crutches. They were followed up at 6 weekly intervals with clinical assessment of their symptoms and radiographs. Fracture union was assessed using serial radiographs with healing defined as filling of fracture gap, bridging callus and clinical assessment including return to full painless weight bearing. Results. Follow-up at 6 months showed all fractures had healed with no defect or gaps with evidence of new trabecular bone and significant resorption of Cerament-G. TM. at final follow-up. There was no evidence of residual infection with restoration of normal limb function. Fractures with no internal fixation showed a mild deformity that had developed during the course of the healing, presumed due to mild collapse in the absence of fixation. These were less than 10 degrees in sagittal and coronal planes and were clinically felt to be insignificant by the patients. Conclusions. Cerament-G's unique combination of high dose antibiotics and hydroxy apatite matrix provided by calcium sulphate might help provide an osteoconductive environment to allow these stiff non-unions to heal. The matrix appears to provide a scaffold-like structure that allows new bone in-growth with local release of antibiotics helping reduce deep-seated infections. The final deformation at fracture site underlines the need for fixation- and it is very unlikely that this technique will work in mobile nonunions. Whilst similar fractures may heal without the use of bone substitute injections, the speed of healing in presence of significant fracture gap suggests the use of these bone substitutes did help in our cases. Further studies with a larger cohort, including RCTs, to evaluate the effectiveness of this technique compared to other methods are needed


Acute Compartment Syndrome (ACS) is an orthopaedic emergency that can develop after a wide array of etiologies. In this pilot study the MY01 device was used to assess its ease of use and its ability to continuously reflect the intracompartmental pressure (ICP) and transmit this data to a mobile device in real time. This preliminary data is from the lead site which is presently expanding data collection to five other sites as part of a multi-center study. Patients with long bone trauma of the lower or upper extremity posing a possibility of developing compartment syndrome were enrolled in the study. Informed consent was obtained from the patients. A Health Canada licensed continuous compartmental pressure monitor (MY01) was used to measure ICP. The device was inserted in the compartment that was deemed most likely to develop ACS and ICP was continuously measured for up to 18 hours. Fractures were classified according to the AO/OTA classification. Patient clinical signs and pain levels were recorded by healthcare staff during routine in-patient monitoring and were compared to the ICP from the device. Important treatment information was pulled from the patient's chart to help correlate all of the patient's data and symptoms. The study period was conducted from November 2020 through December 2021. Twenty-six patients were enrolled. There were 17 males, and nine females. The mean age was 38 years (range, 17–76). Seventeen patients received the device post-operatively and nine received it pre-operatively. Preliminary results show that post-operative ICPs tend to be significantly higher than pre-operative ICPs but tend to trend downwards very quickly. The trend in this measurement appears to be more significant than absolute numbers which is a real change from the previous literature. One patient pre-operatively illustrated a steep trend upwards with minimal clinical symptoms but required compartment release at the time of surgery that exhibited no muscle necrosis. The trend in this patient was very steep and, as predicted, predated the clinical findings of compartment syndrome. This trend allows an early warning signal of the absolute pressure, to come, in the compartment that is being assessed by the device. Preliminary results suggest that this device is reliable and relatively easy to use within our institutions. In addition it suggests that intracompartmental pressures can be higher immediately post-op but lower rapidly when the patient does not develop ACS. These results are in line with current literature of the difference between pre and post-operative baselines and thresholds of ICP, but are much more striking, as continuous measurements have not been part of the data set in most of past studies. Further elucidation of the pressure thresholds and profiles are currently being studied in the ongoing larger multicenter study and will add to our understanding of the critical values. This data, plus the added value of continuous trends in the pressure, upwards or downwards, will aid in preventing muscle necrosis during our management of these difficult long bone fractures


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_13 | Pages 56 - 56
1 Dec 2022
Bishop E Kuntze G Clark M Ronsky J
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Individuals with multi-compartment knee osteoarthritis (KOA) frequently experience challenges in activities of daily living (ADL) such as stair ambulation. The Levitation “Tri-Compartment Offloader” (TCO) knee brace was designed to reduce pain in individuals with multicompartment KOA. This brace uses novel spring technology to reduce tibiofemoral and patellofemoral forces via reduced quadriceps forces. Information on brace utility during stair ambulation is limited. This study evaluated the effect of the TCO during stair descent in patients with multicompartment KOA by assessing knee flexion moments (KFM), quadriceps activity and pain. Nine participants (6 male, age 61.4±8.1 yrs; BMI 30.4±4.0 kg/m2) were tested following informed consent. Participants had medial tibiofemoral and patellofemoral OA (Kellgren-Lawrence grades two to four) diagnosed by an orthopaedic surgeon. Joint kinetics and muscle activity were evaluated during stair descent to compare three bracing conditions: 1) without brace (OFF); 2) brace in low power (LOW); and 3) brace in high power (HIGH). The brace spring engages from 60° to 120° and 15° to 120° knee flexion in LOW and HIGH, respectively. Individual brace size and fit were adjusted by a trained researcher. Participants performed three trials of step-over-step stair descent for each bracing condition. Three-dimensional kinematics were acquired using an 8-camera motion capture system. Forty-one spherical reflective markers were attached to the skin (on each leg and pelvis segment) and 8 markers on the brace. Ground reaction forces and surface EMG from the vastus medialis (VM) and vastus lateralis (VL) were collected for the braced leg. Participants rated knee pain intensity performing the task following each bracing condition on a 10cm Visual Analog Scale ranging from “no pain” (0) to “worst imaginable pain” (100). Resultant brace and knee flexion angles and KFM were analysed during stair contact for the braced leg. The brace moment was determined using brace torque-angle curves and was subtracted from the calculated KFM. Resultant moments were normalized to bodyweight and height. Peak KFMs were calculated for the loading response (Peak1) and push-off (Peak2) phases of support. EMG signals were normalized and analysed during stair contact using wavelet analysis. Signal intensities were summed across wavelets and time to determine muscle power. Results were averaged across all 3 trials for each participant. Paired T-tests were used to determine differences between bracing conditions with a Bonferroni adjustment for multiple comparisons (α=0.025). Peak KFM was significantly lower compared to OFF with the brace worn in HIGH during the push-off phase (p Table 1: Average peak knee flexion moments, quadriceps muscle power and knee pain during stair descent in 3 brace conditions (n=9). Quadriceps activity, knee flexion moments and pain were significantly reduced with TCO brace wear during stair descent in KOA patients. These findings suggest that the TCO assists the quadriceps to reduce KFM and knee pain during stair descent. This is the first biomechanical evidence to support use of the TCO to reduce pain during an ADL that produces especially high knee forces and flexion moments. For any figures or tables, please contact the authors directly


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 347 - 347
1 Dec 2013
Higa M Chang C Roche C Struk A Farmrer K Wright T Banks S
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Introduction. Persistent problems and relatively high complication rates with reverse total shoulder arthroplasty (RTSA) are reported (1, 2). It is assumed that some of these complications are affected by improper intraoperative soft tissue tension. Achieving proper intraoperative soft tissue tension is an obvious surgical goal. However, intraoperative soft tissue tension measurements and methods for RTSA have not been reported. One way to quantify soft tissue tension is to measure intraoperative joint forces using an instrumented prosthesis. Hence, we have developed an instrumented RTSA to measure shoulder joint forces intraoperatively. The goal of this study was to measure intraoperative shoulder joint forces during RTSA. Materials and Methods. The instrumented shoulder prosthesis measures the contact force vector between the glenosphere and humeral tray. This force sensor is a custom instrumented trial implant that can be used with an existing RTSA system (EQUINOXE, Exactech Inc, Gainesville, FL) just as a standard trial implant is used. Four uniaxial foil strain gauges (QFLG-02-11-3LJB, Tokyo Sokki Kenkyujo Co., Ltd., JP) are instrumented inside the sensor. Using a calibration matrix, the three force components were calculated from four strain gauge outputs (3). Sixteen patients who underwent RTSA took part in this IRB approved study. All patients were greater than 50 years of age and willing to review and sign the study informed consent form. After obtaining informed consent for surgery, a standard deltopectoral approach to the shoulder was performed. The instrumented trial prostheses were assembled on the glenoid baseplate instead of a standard glenosphere. After the joint was reduced, joint forces were recorded during cyclic rotation, flexion, scapular plane movement (scaption), and adduction of the shoulder. Strain gauge outputs were recorded during these movements as well as the neutral position just before movements. Mean values of forces with each motion were compared by one-way analysis of variance (ANOVA). A multiple comparisons test was subsequently performed to examine differences between motions. Results. Three sensors failed due to intraoperative breakage of strain gauge wires, leaving 13 subjects with measured joint reaction forces. During abduction, for example, the force vector varied from superior to antero-medial, and the resultant joint force in abduction was 83 N in a representative subject (Figure 1). Average joint reaction forces decreased with shoulder motion from a neutral position to external rotation or scaption. Conversely, they increased with flexion or abduction (Figure 2). Mean force values were not the same for each movement (p = 0.018). Forces recorded during flexion and scaption movements differed significantly (p = 0.012). Discussion. The intraoperative forces acting in the RTSA have been measured for the first time, and these measurements are ongoing. We expect more measurements will permit surgeons objectively to place and align implant components to achieve predictable and durable RTSA results


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_8 | Pages 58 - 58
1 Aug 2020
Burgesson B Glazebrook M Daniels T Younger A
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Ankle arthrodesis and replacement are the widely accepted options in managing end-stage ankle arthritis. Ankle replacement as an alternate treatment option for ankle arthritis is relatively new and this is in large part to the successes observed with hip and knee arthroplasty for arthritis. Relative benefits of ankle replacement and arthrodesis remains a contentious topic. We conducted a multicenter pilot randomized controlled trial, first of its kind, comparing the clinical outcomes of ankle arthrodesis and ankle replacement in managing ankle arthritis. We hypothesized that clinical outcomes would be similar for both. Patients recruited for this study were part of Canadian Orthopaedic Foot and Ankle Society (COFAS) Database. Canadian orthopaedic surgeons with fellowship training in foot and ankle surgery or extensive experience in the surgical treatment of end stage ankle arthritis determined whether the patient met the criteria for randomization, skeletal maturity, symptomatic ankle arthritis no longer amenable to non-operative management, and ability to give informed consent. Data was collected on patient demographics, follow-up time period, complication rates, and Ankle Osteoarthritis Scale (AOS) and Short Form-36 (SF-36) scores. Our analysis of clinical outcomes was divided into two parts: (1) comparison of pre and postoperative data for each cohort separately, and (2) comparison of outcome scores, and revision rates between both cohorts. We employed the Student's t-test and calculated effect sizes in assessing improvements in AOS and SF-36 scores from baseline to latest follow-up within and between the two groups. We also examined postoperative complication and reoperation rates in the study population using the standardized coding system for reoperations following ankle replacement and arthrodesis. Thirty-nine ankles were enrolled in the study with a mean follow-up of 5.1 ± 2.8 years. Ankle osteoarthritis scale scores improved significantly from baseline and last follow-up in both groups. The average baseline AOS total score for ankle replacement improved from 59.4 ±15.9 to 38 ±20 at last follow-up (p-value 19.7 to 31.8 ±16.5 at last follow-up (p-value 25.4 compared to ankle replacement's 20.3 ±23. Two major complications (10.5%) were observed in the ankle replacement cohort while the ankle arthrodesis cohort saw four major complications (20%). Clinical outcomes of ankle replacement and arthrodesis were comparable. The ankle arthrodesis cohort held a slight advantage over ankle replacement in improvement of AOS scores, though not statistically significant. Rates of major complications and reoperations were higher with ankle arthrodesis


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_7 | Pages 55 - 55
1 Jul 2020
Epure LM Grant M Alaqeel M Antoniou J Mwale F
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Osteoarthritis (OA) is a chronic degenerative joint disorder that affects millions of people. There are currently no therapies that reverse or repair cartilage degradation in OA patients. Link N (DHLSDNYTLDHDRAIH) is a naturally occurring peptide that has been shown to increase both collagen and proteoglycan synthesis in chondrocytes and intervertebral disc cells [1,2]. Recent evidence indicates that Link N activates Smad1/5 signaling in cultured rabbit IVD cells presumably by interacting with the bone morphogenetic protein (BMP) type II receptor [3], however, whether a similar mechanism exists in chondrocytes remains unknown. In this study we determined whether Link N can stimulate matrix production and reverse degradation of human OA cartilage under inflammatory conditions. OA cartilage was obtained from donors undergoing total knee arthroplasty with informed consent. OA cartilage/bone explants and OA chondrocytes were prepared from each donor. Cells were prepared in alginate beads (2×106 cells/mL) for gene expression analysis using qPCR. Cells and cartilage explants were exposed to IL-1β (10ng/ml), human Link N (hLN) (1μg/ml) or co-incubated with IL-1β+hLN for 7 and 21 days, respectively. Media was supplemented every three days. Cartilage/bone explants were measured for total glycosaminoglycan (GAG) content (retained and released) using the dimethylmethylene blue (DMMB) assay. Western blotting was performed to determine aggrecan and collagen expression in cartilage tissue. To determine NFκB activation, Western blotting was performed for detection of P-p65 in chondrocytes cultured in 2D following 10 min exposure of IL-1β in the presence of 10, 100, or 1000 ng/mL hLN. Link N significantly decreased in a dose-dependent manner IL-1β-induced NFκB activation in chondrocytes. Gene expression profiling of matrix proteins indicated that there was a trend towards increased aggrecan and decreased collagen type I expression following hLN and IL-1β co-incubation. HLN significantly decreased the IL-1β-induced expression of catabolic enzymes MMP3 and MMP13, and the neuronal growth factor NGF (p < 0 .0001, n=3). In OA cartilage/bone explants, hLN reversed the loss of proteoglycan in cartilage tissue and significantly increased its synthesis whilst in the presence of IL-1β. Link N stimulated proteoglycan synthesis and decreased MMP expression in OA chondrocytes under inflammatory conditions. One mechanism for Link N in preserving matrix protein synthesis may, in part, be due to its ability in rapidly suppressing IL-1β-induced activation of NF-κB. Further work is needed to determine whether Link N directly inhibits the IL-1β receptor or interferes with NFκB activation through an independent pathway(s)


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_8 | Pages 57 - 57
1 Aug 2020
Almaazmi K Beaupre L Menon MRG Tsui B
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We performed a randomized feasibility trial to examine the impact of preoperative femoral nerve block (FNB) on elderly patients with hip fractures, including those with mild to moderate cognitive impairment. We evaluated the impact of preoperative FNB on the following outcomes within 5 days of surgical fixation: 1. Pain levels, 2. Total narcotic consumption, 3. Postoperative mobilization. Randomized allocation of 73 patients in a 2:1 intervention:control ratio. To allow comparison between the 2 groups as well as sub- analysis of the intervention group to examine treatment fidelity (i.e. the ability to deliver the intervention as planned). Inclusion criteria: Patient age≥ 65 years admitted with a low energy hip fracture, ambulatory preinjury, Mini Mental State Exam MMSE score≥13 (moderate dementia), Able to provide direct or proxy consent. Exclusion criteria: Admission ≥ 30 hours after injury, prior regular use of opiates. Potential participants were identified and either participants or proxy respondents provided signed informed consent. Participants allocated to the intervention group received a FNB administered by the UAH acute pain service (APS) within 20 hours of admission to hospital in addition to the usual care. Participants in the control group received usual care. Participants were followed for 5 days postoperatively with daily assessment of pain, narcotic consumption, delirium and mobility. Main outcome measure: (1) Pain at rest and activity (2) Preoperative and postoperative opioid consumption, (3) Mobilization in POD#1. Overall, 73 participants were enrolled (23 Control: 50 FNB). The FNB group was slightly older (mean [SD] 80.1 [8.7] vs. 76.2 [9.2], p=0.09) and had more males (21 [42%] vs. 5 [22%], p=0.09) than the Control group. The mean MMSE score for both groups was >24 (p=0.35 for group comparison), suggesting minimal cognitive impairment of participants. The FNB group reported significantly less pain at rest and activity than the control group over time (p < 0 .001 for both). Opioid consumption were non-significantly higher and more variable in the control group preoperatively (Median [25, 75 quartile] 10.6 [0, 398] vs 7.5 [0, 125], p=0.26) and postoperatively (13.1 [0, 950] vs 10 [0, 260], p=0.31). 41 (85%) of FNB participants mobilized on day 1 vs. 16 (73%) of control participants (p=0.21). Preoperative FNB significantly reduced pain. Opioid consumption was not significantly different, but more variable in the control group. Although not significant, more FNB patients successfully mobilized on day 1 postoperatively. Participants with cognitive impairment were not enrolled due to difficulty in obtaining proxy consent. A definitive randomized trial would be feasible and add valuable information about pain management following hip fracture


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_8 | Pages 89 - 89
1 Aug 2020
Bourget-Murray J Kendal J Schneider P Montgomery S Kooner S Kubik J Meldrum A Kwong C Gusnowski E Thomas K Fruson L Litowski M Sridharan S You D Purnell J James M Wong M Ludwig T Abbott A Lukenchuk J Benavides B Morrison L
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Advances in orthopaedic surgery have led to minimally invasive techniques to decrease patient morbidity by minimizing surgical exposure, but also limits direct visualization. This has led to the increased use of intraoperative fluoroscopy for fracture management. Unfortunately, these procedures require the operating surgeon to stay in close proximity to the patient, thus being exposed to radiation scatter. The current National Council on Radiation Protection recommends no more than 50 mSv of radiation exposure to avoid ill-effects. Risks associated with radiation exposure include cataracts, skin, breast and thyroid cancer, and leukemia. Despite radiation protection measures, there is overwhelming evidence of radiation-related diseases in orthopaedic surgeons. The risk of developing cancer (e.g. thyroid carcinoma and breast cancer) is approximately eight times higher than in unexposed workers. Despite this knowledge, there is a paucity of evidence on radiation exposure in orthopaedic surgery residents, therefore the goal of this study is to quantify radiation exposure in orthopaedic surgery residents. We hypothesize that orthopaedic surgery residents are exposed to a significant amount of radiation throughout their training. We specifically aim to: 1) quantify the amount of radiation exposure throughout a Canadian orthopaedic residency training program and 2) determine the variability in resident radiation exposure by rotation assignment and year of training. This ongoing prospective cohort study includes all local orthopaedic surgery residents who meet eligibility criteria. Inclusion criteria: 1) adult residents in an orthopaedic surgery residency program. Exclusion criteria: 1) female residents who are pregnant, and 2) residents in a non-surgical year (i.e. leave of absence, research, Masters/PhD). After completion of informed consent, each eligible resident will wear a dosimeter to measure radiation exposure in a standardized fashion. Dosimeters will be worn on standardized lanyards underneath lead protection in their left chest pocket during all surgeries that require radiation protection. Control dosimeters will be worn on the outside of each resident's scrub cap for comparison. Dosimeter readings will then be reported on a monthly and rotational basis. All data will be collected on a pre-developed case report form. All data will be de-identified and stored on a secure electronic database (REDCap). In addition to monthly and rotational dosimeter readings, residents will also report sex, height, level of training, parental status, and age for secondary subgroup analyses. Residents will also report if they have personalized lead or other protective equipment, including lead glasses. Resident compliance with dosimeter use will be measured by self report of >80% use on operative days. Interim analysis will be performed at the 6-month time point and data collection will conclude at the 1 year time point. Data collection began in July 2018 and interim 6-month results will be available for presentation at the CORA annual meeting in June 2019. This is the first prospective study quantifying radiation exposure in Canadian orthopaedic residents and the results will provide valuable information for all Canadian orthopaedic training programs


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_3 | Pages 13 - 13
1 Apr 2019
Waliullah S Kumar V Rastogi D Srivastava RN
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Spinal tuberculosis is one of the most common presentations of skeletal tuberculosis. It is one of the major health issues of developing countries as it is associated with significant morbidity and mortality. Pott's paraplegia is a dreaded complication which can result in permanent neurological deficit, unless treated by timely intervention. We evaluated the efficacy of transpedicular decompression and functional recovery in patients of spinal tuberculosis with neurological deficit. A cohort of 23 patients (15 males and 8 female) with diagnosed spinal tuberculosis and having an average age of 37.5±8.4 years, satisfying our inclusion and exclusion criteria's and giving written informed consent were recruited in our study. All patients were managed by transpedicular decompression and fusion with posterior instrumentation. All the patients were followed up clinically, radiologically and hematologically. Patients were followed up at every six weeks for 4 months and thereafter at three monthly intervals to assess the long term outcomes and complications. Neurological evaluation was done by Frankel grading. Functional outcome was assessed by Visual Analog Score (VAS) and Owestry Disability Index score (ODI score). All the patients were followed for a minimum of 27 months. At the final follow-up, there was a statistically significant improvement in VAS score and ODI score. Out of 23 patients, all except three patients showed neurological recovery. We observed that transpedicular decompression is safe and effective approach for management of spinal tuberculosis as it allows adequate decompression of spinal cord while pedicular instrumentation provides stable spinal fixation and helps in early rehabilitation


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_3 | Pages 18 - 18
1 Apr 2019
Lee P Chandratreya AP
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Background of study. Following the Montgomery ruling, consent is now a matter of law. The medical professionals have to show proof that risks and implications and material risks are explained to the patient and that they have accepted to go ahead with surgery. Materials and Methods. We devised a free web based programme (. www.consentplus.com. ) which introduces a documented checkpoint to the consent process in hip and knee replacement surgery. It enables reproducible high-quality bite-sized information delivery to patients and their families in an optimal environment. It utilises the flip classroom principle to facilitate dialogue between doctors and patients. It generates physical documentation to show patients’ knowledge and understanding of the risks; to produce a truly informed consent. Results. 1567 users completed the Consent PLUS process over 28 hospitals across the UK. 98.1% of users were satisfied with Consent PLUS in terms of quality of service and information delivered. Users’ self-rated knowledge increased by 29%, independent of age group, prior knowledge or check-point scores. Supportive documentation for 100% of the users, which facilitated the consent process but did not replace the consultation. 60% of users accessed the system via desktop computers, 23% via tablet and 17% via mobile phone. 55 consultant surgeons and 28 hospitals have been registered into the system by the users. 96.9% of users found Consent PLUS useful and 96.3% would recommend it to their friends. 92.6% would use it again. Conclusion. Consent PLUS can facilitate information delivery and improve patients’ understanding of the risks of surgery and its implications subjectively and objectively. Consent PLUS is a tool designed to enhance and facilitate the consent process, not to replace the current consent forms


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_1 | Pages 55 - 55
1 Feb 2020
Oshima Y Watanabe N Takeoka T Iizawa N Majima T Takai S
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Introduction. Upright body posture is maintained with the alignment of the spine, pelvis, and lower extremities, and the muscle strength of the body trunk and lower extremities. Conversely, the posture is known to undergo changes with age, and muscle weakness of lower extremities and the restriction of knee extension in osteoarthritis of the knee (knee OA) have been considered to be associated with loss of natural lumbar lordosis and abnormal posture. As total knee arthroplasty (TKA) is aimed to correct malalignment of lower extremities and limited range of motion of knee, particularly in extension, we hypothesized that TKA positively affects the preoperative abnormal posture. To clarify this, the variation in the alignment of the spine, pelvis, and lower extremities before and after TKA was evaluated in this study. Patients and methods. Patients suffering from primary knee OA who were scheduled to receive primary TKA were enrolled in this study. However, patients with arthritis secondary to another etiology, i.e. rheumatoid arthritis, trauma, or previous surgical interventions to the knee, were excluded. Moreover, patients who suffered from hip and ankle OA, cranial nerve diseases, or severe spinal deformity were also excluded. The sagittal vertical axis (SVA), the horizontal distance between the posterosuperior aspect of the S1 endplate surface and a vertical plumb line drawn from the center of the C7 vertebral body, is an important index of sagittal balance of the trunk. Thus, patients were classified into two groups based on the preoperative SVA with preoperative standing lateral digital radiographs: normal (< 40mm) and abnormal (≥ 40mm) groups. The variations in the sagittal alignment of the spine, pelvis and lower extremities were evaluated preoperatively, and at 1 and 3 months postoperatively. This study was approved by an institutional review board, and informed consent for participation was obtained from the patients. Results. Forty-nine knees in 49 patients were enrolled. Three different patterns of postural changes as well as hip and knee angles following TKA were observed. After TKA, the preoperatively normal SVA patients (26.5%) showed extension of the hip and knee joints and decrease of lumbar lordosis, while the SVA remained almost within the normal range. In the preoperatively abnormal SVA group, 13 patients (26.5%) showed extension of the knee joint while the SVA remained abnormal, however, 23 of the preoperatively abnormal SVA group patients (47.0%) showed improvement of SVA into the normal range with the extension of the hip and knee joints. Discussion. As the spine, pelvis, and lower extremities together affect body alignment, once limitation of knee extension due to severe knee OA is corrected and lower extremity alignment is improved with TKA, the lumbar lordosis may increase, and SVA could decrease. Recently, the relationship between the imbalance of the sagittal plane of the body and the risk of falls was described. From this, it could be said that TKA not only helped in recovering knee function and lower extremity alignment in severe knee OA, but also helped to improve posture and to protect from falls