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Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_14 | Pages 28 - 28
1 Dec 2022
Brodano GB
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Adverse events (AEs) are still a major problem in spinal surgery, despite advances in surgical techniques, innovative technologies available and the introduction of checklist and predictive score systems aimed at reducing surgical complications. We previously analysed the results of the introduction of the WHO Safety Surgical Checklist (SSC) in our Institution, comparing the incidence of complications between two periods: from January to December 2010 (without checklist) and from January 2011 and December 2012 (with checklist), in order to assess the checklist effectiveness. The sample size was 917 patients with an average of 30 months of follow-up. Complications were observed in 107 patients (11.6%) among 917 spinal surgery procedures performed, with 159 (17.3%) complications in total. The overall incidence of complications for trauma, infectious pathology, oncology, and degenerative disease was 22.2%, 19.2%, 18.4%, and 15.3%, respectively. We observed a reduction of the overall incidence of complications following the introduction of the WHO Surgical Checklist: in 2010 without checklist, the incidence of complications was 24.2%, while in 2011 and 2012, following the checklist introduction, the incidence of complications was 16.7% and 11.7%, respectively (mean 14.2%) (p<0.0005). Thus, the SSC appeared to be an effective tool to reduce complications in spinal surgery and we proposed to extend the use of checklist system also to the pre-operative and post-operative phases in order to further reduce the incidence of complications. We also believe that a correct capture and classification of complications is fundamental to generate a clinical decision support system aimed at improving patients’ safety in spinal surgery. In the period between January 2017 and January 2018 we prospectively recorded the adverse events and complications of patients undergoing spinal surgery in our department, without using any collection system. Then we retrospectively recorded the intraoperative and postoperative adverse events of surgically treated patients during the same one-year period, using the SAVES v2 system introduced by Rampersaud and collaborators (Rampersaud YR et al. J Neurosurg Spine 2016 Aug; 25 (2): 256-63) to classify them. In the one-year period from January 2017 to January 2018 a total of 336 patients underwent spinal surgery: 223 for degenerative conditions and 113 for spinal tumors. Comorbidities were collected (Charlson Comorbidity Index [CCI]). Overall, a higher number of adverse events (AEs) was recorded using SAVES compared to the prospective recording without the use of any capture system and the increased number was statistically significant for early postoperative AEs (138/336 vs 44/336, p<0.001). 210 adverse events were retrospectively recorded using the SAVES system (30 intraoperative adverse events, 138 early postoperative and 42 late postoperative adverse events). 99 patients (29.5%) on the cohort had at least one complication. Furthermore, the correlation between some risk factors and the onset of complications or the prolonged length of stay was statistically analyzed. The risk factors taken into account were: age, presence of comorbidities (CCI), ASA score, previous surgery at the same level, type of intervention, location of the disease, duration of the surgery. In particular, the duration of the surgery (more than 3 hours) and the presence of previous surgeries resulted to be risk factors for complications in multivariate analyses


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_14 | Pages 38 - 38
1 Dec 2022
Tedesco G Evangelisti G Fusco E Ghermandi R Girolami M Pipola V Tedesco E Romoli S Fontanella M Brodano GB Gasbarrini A
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Neurological complications in oncological and degenerative spine surgery represent one of the most feared risks of these procedures. Multimodal intraoperative neurophysiological monitoring (IONM) mainly uses methods to detect changes in the patient's neurological status in a timely manner, thus allowing actions that can reverse neurological deficits before they become irreversible. The utopian goal of spinal surgery is the absence of neurological complications while the realistic goal is to optimize the responses to changes in neuromonitoring such that permanent deficits occur less frequently as possible. In 2014, an algorithm was proposed in response to changes in neuromonitoring for deformity corrections in spinal surgery. There are several studies that confirm the positive impact that a checklist has on care. The proposed checklist has been specifically designed for interventions on stable columns which is significantly different from oncological and degenerative surgery. The goal of this project is to provide a checklist for oncological and degenerative spine surgery to improve the quality of care and minimize the risk of neurological deficit through the optimization of clinical decision-making during periods of intraoperative stress or uncertainty. After a literature review on risk factors and recommendations for responding to IONM changes, 3 surveys were administered to 8 surgeons with experience in oncological and degenerative spine surgery from 5 hospitals in Italy. In addition, anesthesiologists, intraoperative neuro-monitoring teams, operating room nurses participated. The members participated in the optimization and final drafting of the checklist. The authors reassessed and modified the checklist during 3 meetings over 9 months, including a clinical validation period using a modified Delphi process. A checklist containing 28 items to be considered in responding to the changes of the IONM was created. The checklist was submitted for inclusion in the new recommendations of the Italian Society of Clinical Neurophysiology (SINC) for intraoperative neurophysiological monitoring. The final checklist represents the consensus of a group of experienced spine surgeons. The checklist includes the most important and high-performance items to consider when responding to IONM changes in patients with an unstable spine. The implementation of this checklist has the potential to improve surgical outcomes and patient safety in the field of spinal surgery


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_14 | Pages 26 - 26
1 Dec 2022
Salamanna F Contartese D Borsari V Griffoni C Brodano GB Gasbarrini A Fini M
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The Spine Surgery Unit of IRCCS Istituto Ortopedico Rizzoli is dedicated to the diagnosis and the treatment of vertebral pathologies of oncologic, degenerative, and post-traumatic origin. To achieve increasingly challenging goals, research has represented a further strength for Spinal Surgery Unit for several years. Thanks to the close synergy with the Complex Structure Surgical Sciences and Technologies, IRCCS Istituto Ortopedico Rizzoli, extensive research was carried out. The addition of the research activities intensifies a complementary focus and provides a unique opportunity of innovation. The overall goal of spine research for the Spine Surgery Unit and for the Complex Structure Surgical Sciences and Technologies is and has been to:. - investigate the factors that influence normal spine function;. - engineer and validate new and advanced strategies for improving segmental spinal instrumentation, fusion augmentation and grafting;. - develop and characterize advanced and alternative preclinical models of vertebral bone metastasis to test drugs and innovative strategies, taking into account patient individual characteristics and specific tumour subtypes so predicting patient specific responses;. - evaluate the clinical characteristics, treatment modalities, and potential contributing and prognostic factors in patients with vertebral bone metastases;. - realize customized prosthesis to replace vertebral bodies affected by tumours or major traumatic events, specifically engineered to reduce infections, and increase patients’ surgical options. These efforts have made possible to obtain important results that favour the translation of basic research to application at the patient's bedside, and from here to routine clinical practice (without excluding the opposite pathway, in which the evidence generated by clinical practice helps to guide research). Although translational research can provide patients with valuable therapeutic resources, it is not risk-free. Thus, it is therefore necessary an always close collaboration between researchers and clinicians in order to guarantee the ethicality of translational research, by promoting the good of individuals and minimising the risks


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_14 | Pages 11 - 11
1 Nov 2018
Foong B Jani P
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There is an inherent risk of iatrogenic new neurological deficit (NND) arising at the spinal cord, cauda equina and nerve root during spinal surgery. Intraoperative neurophysiological monitoring (IONM) can be employed to preserve spinal cord function during spinal surgery. IONM techniques include somatosensory and motor evoked potentials, amongst others. A Canadian survey of 95 spinal surgeons showed that 62.1% used IONM and a similar survey in France of 117 spinal surgeons showed that only 36% used IONM. Unavailability was a common reason for its disuse. Current literature by the British Society of Clinical Neurophysiology has outlined the importance of IONM in preventing NND and the need for the implementation of guidelines for IONM. The lack of an established guideline has resulted in a varied approach in the use of IONM in England. There has been no previous attempt to ascertain the current use of IONM in England. Our study is aimed at assessing the variability of the use of IONM in England as well as identifying the rationale amongst surgeons that dictate their use of IONM. We are in the process of investigating the indications of use of IONM for cervical and lumbar spine procedures in 252 spinal surgeons from 33 hospitals with spinal services. Our survey will illustrate the current use of IONM in spinal surgery in England. It will highlight some of the reasons for the variability of use of IONM and identify factors that can contribute to a more standardised use of IONM in spinal surgery


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_11 | Pages 60 - 60
1 Dec 2020
Brodano GB Griffoni C Halme J Tedesco G Terzi S Bandiera S Ghermandi R Evangelisti G Girolami M Pipola V Falavigna A Gasbarrini A
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Introduction. To face the problem of surgical complications, which is generally relevant in surgical fields, an intraoperative checklist (Safety Surgical Checklist, SSC) was elaborated and released by the World Health Organization in 2008, and its use has been described in 2009. In our Institution, the WHO SSC was introduced in 2011. In spinal surgery, many preventive measures were investigated to reduce complications, but there is no report on the effectiveness of the WHO checklist in reducing complications. Aim. The aim of this study was to compare the incidence of complications between the two periods, from January to December 2010 (without checklist) and from January 2011 to December 2012 (with checklist), in order to assess the checklist effectiveness. Materials and Methods. A retrospective and single center study was carried out on patients who underwent spinal surgery during the three-year period from January 2010 to December 2012. Patients were classified according to the spine pathology and the different presentation of the complication. We registered the complications arising in patients treated from 2010 to 2012 during a 3 years follow up period for each patient, assessing the possible differences before and after the checklist's introduction. Results. The sample size was 917 patients, the mean age was 52.88 years. The majority of procedures were performed for oncological diseases (54.4%) and degenerative diseases (39.8%). 159 complications in total were detected (17.3%). The overall incidence of complications for trauma, infectious pathology, oncology, and degenerative disease was 22.2%, 19.2%, 18.4%, and 15.3%, respectively. No correlation was observed between the type of pathology and the complication incidence. We observed a reduction of the overall incidence of complications following the introduction of the SSC: in 2010 without checklist, the incidence of complications was 24.2%, while in 2011 and 2012, following the checklist introduction, the incidence of complications was 16.7% and 11.7%, respectively (mean 14.2%). Conclusion. Despite the limitations of the study, in particular the impossibility to carry out a randomized study, SSC seems to be an effective tool to reduce complications in spinal surgery. We propose to extend the use of checklist system also to the pre-operative and post-operative phases in order to further reduce the incidence of complications


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_4 | Pages 84 - 84
1 Apr 2018
Trimboli M Simpson AI Savin S Chatterjee S
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Introduction. Guidelines from the North American Spine Society (2009 and 2013) are the best evidence-based instructions on venous thromboembolism (VTE) and antibiotic prophylaxis in spinal surgery. NICE guidelines exist for VTE prophylaxis but do not specifically address spinal surgery. In addition, the ruling of the UK Supreme Court in 2015 resulted in new guidance on consent being published by the Royal College of Surgeons of England (RCSEng). This study assesses our compliance in antibiotic, VTE prophylaxis and consent in spinal surgery against both US and UK standards. Methods. Retrospective review of spinal operations performed between August and December 2016. Case notes, consent forms and operation notes were analysed for consent, peri-operative antibiotic prescribing and post-operative VTE instructions. Results. Four Spinal surgeons performed 45 operations during this period. 31 patients (69%) received a copy of the signed consent with this process being formally documented in 22 (71%) of those cases. All patients were consented by a competent surgeon. 82% of cases consented prior to the date of procedure were countersigned on the day of operation. There was a mean time of 25.3 days between initial consent and operation (Range: 0–170). 37 (82%) cases had clear instructions for VTE and antibiotic prophylaxis. All prescribed post-operative antibiotics were administered. Discussion. The North American Guidelines state that prophylactic antibiotic is appropriate in all spinal surgery with prolonged cases requiring intraoperative re-dosing and only complex cases needing a postoperative regimen. Eight patients underwent a complex procedure and 7 appropriately received postoperative antibiotics. Of the 29 patients that underwent a simple procedure, 12 did not receive post-operative regimen, in line with the guidelines. However, the remainder 17 were over treated. The US Guidelines recommend mechanical VTE prophylaxis only in elective spinal surgery except in high risk patients. All our patients received VTE mechanical prophylaxis. RCSEng guidelines require consent being taken prior to procedure by a competent surgeon and confirmed on day of procedure. All patients in our cohort were consented prior to the date of operation allowing time for considering options and independent research. 82% of patients had consent confirmed on day of operation. Conclusion. This study demonstrates that we met guideline advice for all patients with regards VTE prophylaxis. We have a tendency to over treat with post-operative antibiotics and not all patients had their consent confirmed on day of procedure but was consented well before day of operation. North America still lead the way with guidelines on spinal surgery to which we should adhere, with NICE guidelines providing limited instructions. New consenting guidelines from RCSEng may not be currently widely known and thus should be a source of education for all surgeons


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_17 | Pages 14 - 14
1 Apr 2013
Childs J Khatri M
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Aim. The aim of this study is to evaluate the causes of litigation in spinal surgery and to identify preventable causes. Methods. Retrospective analysis of all claim data made available under Freedom of information act from NHS Litigation Authority between years 2000 to 2010. Results. A total of 581 (331 Orthopaedics and 250 Neurosurgery) claims were filed in England and Wales, of these 543 cases were settled while 38 cases were pending. 371 (69%) of 543 settled resulted in payout but 172 (31%) claims were successfully defended by the NHSLA. Average payout was £63,573 total £ 36935933 maximum payout of £ 1800000). This figure rose to average of £ 95125, (Total £553627720) when defence and claimant costs were included. The allegations categories were 123 failure or delay in diagnosis, 108 intra operative problems, 90 failure or delay in treatment, 45 suboptimal consent and in 40 failure to recognise complications. The successful litigations were result of neurological injury in 143, un necessary operation in 37, avoidable pain in 29, death 15 and Misc 31. Conclusion. Litigation can in part be attributed to the “no win no fee” culture; steps that can be taken to reduce the number of successful claims. Failure or delay in diagnosis and Intra operative problems can partially be attributed to lack of resources and or expertise emphasising the need for spinal surgery to be concentrated in specialist centres. Documented informed consent can also potentially decrease litigation. No conflicts of interest. No funding obtained. This abstract has not been previously published in whole or substantial part nor has it been presented previously at a national meeting


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_4 | Pages 15 - 15
1 Jan 2013
Patel M Newey M Sell P
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Background. The majority of studies assessing minimal clinical important difference in outcome do so for management of chronic low back pain. Those that identify MCID following spinal surgical intervention fail to differentiate between the different pathologies and treatments or use variable methods and anchors in the calculation. Aim. To identify the MCID in scores across the most common spinal surgical procedures using standardised methods of calculation. Method. Prospective longitudinal study following elective lumbar spinal surgery. All patients had a complete set of spinal outcome assessments (ODI and VAS) and self perceived rating of the global and Mcnab criteria. MCID was calculated as defined by Hagg et al. Results. 244 patients of average age 53 years were followed up for 62 months post surgery. The MCID across the range of spinal surgeries was a 10 point change in ODI and 28 points for the VAS. A MCID following lumbar decompression surgery was a 3 point change in ODI and 29 points for VAS; 24 points in ODI and 37 points in the VAS for a discectomy, and 13 points in ODI and 23 point change in VAS for revision surgery. This value also varied depending on the anchor and method used for calculation. Conclusion. The MCID in score varies between different spinal procedures, method of calculation and the external anchor used. Standardised methods of calculating MCID in outcome measures should be used to allow comparative research and assessment. Generalisation of MCID in scores across a range of spinal procedures should be strongly discouraged. Conflicts of Interest. None. Source of Funding. None. This abstract has not been previously published in whole or substantial part nor has it been presented previously at a national meeting


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_1 | Pages 72 - 72
1 Jan 2017
Barbanti Brodano G Halme J Gasbarrini A Bandiera S Terzi S Ghermandi R Babbi L Boriani S
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The surgical treatment of spinal deformities and degenerative or oncological vertebral diseases is becoming more common. However, this kind of surgery is complex and associated to a high rate of early and late complications. We retrospectively collected all the major complications observed in the perioperative and post-operative period for surgeries performed at our Division of Spine Surgery in the 2010–2012 period,. 285 surgeries were registered in 2010, 324 in 2011 and 308 in 2012. All the complications observed during the procedure and the follow-up period were recorded and classified according to the type (mechanical complications, neurological complications, infection, hematoma, cerebrospinal fluid fistula, systemic complications, death related to the surgery). In 2010, on 285 surgeries 47 patients (16.5 %) had 69 complications (24.2%): 25.7% for the treatment of oncological diseases, 23% for the treatment of degenerative diseases, 27% for the treatment of pathologies of traumatic origin, 11% for the treatment of spondylodiscitis (infectious diseases). In 2011, on 324 surgeries 35 patients (10.8 %) had 54 complications (16.7%): 16.3% for the treatment of oncological diseases, 16.3% for the treatment of degenerative diseases, 20% for the treatment of pathologies of traumatic origin, 28.6% for the treatment of spondylodiscitis. In 2012, on 308 surgeries, 25 patients (8.1 %) had 36 complications (11.7%): 14.4% for the treatment of oncological diseases, 7.2% for the treatment of degenerative diseases, 16.7% for the treatment of pathologies of traumatic origin, 20% for the treatment of spondylodiscitis. On 917 spinal surgeries performed from January 2010 to December 2012, 159 complications (17.3%) were recorded, with a prevalence of mechanical complications and infections. We are also prospectively collecting complications related to 2013–2015, in order to have a larger amount of data and try to detect potential risk factors to be taken into consideration in the decision-making process for complex spinal surgery


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_14 | Pages 32 - 32
1 Dec 2022
Ricci A Boriani L Giannone S Aiello V Marvasi G Toccaceli L Rame P Moscato G D'Andrea A De Benedetto S Frugiuele J Vommaro F Gasbarrini A
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Scoliosis correction surgery is one of the longest and most complex procedures of all orthopedic surgery. The complication rate is therefore not negligible and is particularly high when the surgery is performed in patients with neuromuscular or connective tissue disease or complex genetic syndromes. In fact, these patients have various comorbidities and organ deficits (respiratory capacity, swallowing / nutrition, heart function, etc.), which can compromise the outcome of the surgery. In these cases, an accurate assessment and preparation for surgery is essential, also making use of external consultants. To make this phase simpler, more effective and homogeneous, a multidisciplinary path of peri-operative optimization is being developed in our Institute, which also includes the possibility of post-operative hospitalization for rehabilitation and recovery. The goal is to improve the basic functional status as much as possible, in order to ensure faster functional recovery and minimize the incidence of peri-operative complications, to be assessed by clinical audit. The path model and the preliminary results on the first patients managed according to the new modality are presented here.

The multidisciplinary path involves the execution of the following assessments / interventions: • Pediatric visit with particular attention to the state of the upper airways and the evaluation of chronic or frequent inflammatory states • Cardiological Consultation with Echocardiogram. • Respiratory Function Tests, Blood Gas Analysis and Pneumological Consultation to evaluate indications for preoperative respiratory physiotherapy cycles, Non-Invasive Ventilation (NIV) cycles, Cough Machine. Possible Polysomnography. • Nutrition consultancy to assess the need for nutritional preparation in order to improve muscle trophism. • Consultation of the speech therapist in cases of dysphagia for liquids and / or solids. • Electroencephalogram and Neurological Consultation in epileptic patients. • Physiological consultation in patients already being treated with a cough machine and / or NIV. • Availability of postoperative hospitalization in the rehabilitation center (with skills in respiratory and neurological rehabilitation) for the most complex cases. When all the appropriate assessments have been completed, the anesthetist in charge at our Institute examines the clinical documentation and establishes whether the path can be considered complete and whether the patient is ready for surgery. At the end of the surgery, the patient is admitted to the Post-operative Intensive Care Unit of the Institute. If necessary, a new program of postoperative rehabilitation (respiratory, neuromotor, etc.) is programmed in a specialist reference center.

To date, two patients have been referred to the preoperative optimization path: one with Ullrich Congenital Muscular Dystrophy, and one with 6q25 Microdeletion Syndrome. In the first case, the surgery was performed successfully, and the patient was discharged at home. In the second case, after completing the optimization process, the surgery was postponed due to the finding of urethral malformation with the impossibility of bladder catheterization, which made it necessary to proceed with urological surgery first.

The preliminary case series presented here is still very limited and does not allow evaluations on the impact of the program on the clinical practice and the complication rate. However, these first experiences made it possible to demonstrate the feasibility of this complex multidisciplinary path in which a network of specialists takes part.


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_16 | Pages 11 - 11
17 Nov 2023
Wahdan Q Solanke F Komperla S Edmonds C Amos L Yap RY Neal A Mallinder N Tomlinson JE Jayasuriya R
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Abstract

INTRODUCTION

In the NHS the structure of a “regular healthcare team” is no longer the case. The NHS is facing a workforce crisis where cross-covering of ward-based health professionals is at an all-time high, this includes nurses, doctors, therapists, pharmacists and clerks. Comprehensive post-operative care documentation is essential to maintain patient safety, reduce information clarification requests, delays in rehabilitation, treatment, and investigations. The value of complete surgical registry data is emerging, and in the UK this has recently become mandated, but the completeness of post-operative care documentation is not held to the same importance, and at present there is no published standard. This project summarises a 4-stage approach, including 6 audit cycles, >400 reviewed operation notes, over a 5 year period.

OBJECTIVE

To deliver a sustainable change in post operative care documentation practices through quality improvement frameworks.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_4 | Pages 25 - 25
1 Jan 2013
McGregor A Doré C Morris T Morris S Jamrozik K
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Introduction. This study sought to determine whether the functional outcome of two common spinal operations could be improved by a programme of post-operative rehabilitation and/or an educational booklet each compared with usual care. Methods. This was a multi-centre, factorial, randomised controlled trial on the post operative management of spinal surgery patients, with randomisation stratified by surgeon and operative procedure. The study compared the effectiveness of a rehabilitation programme and an education booklet for the postoperative management of patients undergoing discectomy or lateral nerve root decompression surgery, each compared with “usual care” using a 2 × 2 factorial design, randomising patient to four groups; rehabilitation-only, booklet-only, rehabilitation-plus-booklet, and usual care only. The primary outcome measure was the Oswestry Disability Index (ODI) at 12 months, with secondary outcomes including visual analogue scale measures of back and leg pain. An economic analysis was also performed. Results. 338 patients were recruited into the study with outcomes preformed pre-operatively, and postoperatively at 6 weeks, 3, 6, 9 and 12 months post-operatively. At the one year review the effect of rehabilitation on ODI was −2.7 (95% CI −6.8 to 1.5) and the effect of booklet was 2.7 (95% CI −1.5 to 6.9). There were no significant differences in costs or outcomes associated with either intervention and neither intervention was cost-effective. Discussion. This study found that neither intervention had a significant impact on long term outcome or cost. There was some evidence to suggest that the impact of the interventions was different between patients undergoing discectomy and those having spinal decompression. Conflicts of Interest. None. Source of Funding. Arthritis Research UK. Previously presented at International Society for the Study of the Lumbar Spine 2011


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_17 | Pages 8 - 8
1 Apr 2013
Dunderdale CS Wellington K Khatri M
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Aim

To investigate the role of websites in enhancing patients' understanding of reason and risk of surgery as a part of informed consent for elective un-instrumented lumbar spine surgery (EULSS).

Methodology

This was a National Research Ethical Committee approved RCT study. 63 patients underwent EULSS, out of which 14(29%) declined participation and 14(29%) were excluded. One did not have surgery therefore 34 were randomised to Standard (S) and intervention group (I) using sealed envelope. Standard group were given verbal information & leaflet while the Intervention group were given information on relevant section of www.eurospine.org and www.spinesurgeons.ac.uk websites. A 13 item Informed Consent Questionnaire (ICQ) was used to collect data. The primary outcomes were patients' perceived understanding of reason and risk of EULSS.


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_1 | Pages 85 - 85
2 Jan 2024
Zwingenberger S
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Spinal diseases such as unstable fractures, infections, primary or secondary tumors or deformities require surgical stabilization with implants. The long-term success of this treatment is only ensured by a solid bony fusion. The size of the bony defect, the often poor bone quality and metabolic diseases increase the risk of non-union and make the case a great burden for the patient and a challenge for the surgeon. The goal of spinal fusion can only be achieved if the implants used offer sufficient mechanical stability and the local biological regeneration potential is large enough to form sufficient bone. The lecture will present challenging clinical cases. In addition, implant materials and new surgical techniques are discussed. Local therapeutic effects are achieved through the release of osteopromotive or anti-resorbtive drugs, growth factors and antibiotics. By influencing biological pathways, basic orthopedic research has strong potential to further positively change future spinal surgery


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_8 | Pages 100 - 100
11 Apr 2023
Salamanna F Brodano G Griffoni C Gasbarrini A Fini M Leggi L
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Due to the presence of megakaryocytes, platelets and clotting factors, bone marrow aspirate (BMA) tends to coagulate. For the first time, starting from our previous studies on mesenchymal vertebral stem cells, it has been hypothesized that coagulated BMA represents a safe and effective autologous biological scaffold for bone regeneration in spinal surgery. The present research involved advanced preclinical in vitro models and the execution of a pilot clinical study. Evaluation of cell morphology, growth kinetics, immunophenotyping, clonogenicity, trilineage-differentiation, growth-factors and HOX and TALE gene expression were analyzed on clotted- and un-clotted human V-BMA. In parallel, a pilot clinical study on ten patients with degenerative spine diseases submitted to instrumented posterior arthrodesis, is ongoing to assess the ability of clotted-V-BMA to improve spinal fusion at 6- and 12-months follow-up. Results demonstrated that clotted-V-BMA have significantly higher growth-factor expression and mesenchymal stem cell (MSCs) viability, homogeneity, clonogenicity, and ability to differentiate towards the osteogenic phenotype than un-clotted-V-BMA. Clotted-V-BMA also highlighted significant reduced expression of PBX1 and of MEIS3 genes negatively involved in osteoblast maturation and differentiation. From December 2020, eight patients have already been enrolled with first promising results that will be finally evaluated in the next two months. The application of V-BMA-clot as carrier of progenitors and cytokines and as natural scaffold with a structural texture represents a point-of-care orthobiologic product to improve spinal fusion. Clinical application seems to be efficacy, and we will confirm and strengthen these data with the final results of the pilot clinical study


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_14 | Pages 27 - 27
1 Dec 2022
Ghermandi R
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Spinal surgery deals with the treatment of different pathological conditions of the spine such as tumors, deformities, degenerative disease, infections and traumas. Research in the field of vertebral surgery can be divided into two main areas: 1) research lines transversal to the different branches; 2) specific research lines for the different branches. The transversal lines of research are represented by strategies for the reduction of complications, by the development of minimally invasive surgical techniques, by the development of surgical navigation systems and by the development of increasingly reliable systems for the control of intra-operative monitoring. Instead, specific lines of research are developed within the different branches. In the field of oncological pathology, the current research concerns the development of in vitro models for the study of metastases and research for the study of targeted treatment methods such as electrochemotherapy and mesenchymal stem cells for the treatment of aneurysmal bone cysts. Research in the field of spinal deformities is focused on the development of increasingly minimally invasive methods and systems which, combined with appropriate pharmacological treatments, help reduce trauma, stress and post-operative pain. Scaffolds based on blood clots are also being developed to promote vertebral fusion, a fundamental requirement for improving the outcome of vertebral arthrodesis performed for the treatment of degenerative disc disease. To improve the management and the medical and surgical treatment of vertebral infections, research has focused on the definition of multidisciplinary strategies aimed at identifying the best possible treatment path. Thus, flow-charts have been created which allow to manage the patient suffering from vertebral infection. In addition, dedicated silver-coated surgical instrumentation and bone substitutes have been developed that simultaneously guarantee mechanical stability and reduce the risk of further local infection. In the field of vertebral traumatology, the most recent research studies have focused on the development of methods for the biostimulation of the bone growth in order to obtain, when possible, healing without surgery. Methods have also been developed that allow the minimally invasive percutaneous treatment of fractures by means of vertebral augmentation with PMMA, or more recently with the use of silicone which from a biomechanical point of view has an elastic modulus more similar to that of bone. It is clear that scientific research has changed clinical practice both in terms of medical and surgical management of patients with spinal pathologies. The results obtained stimulate the basic research to achieve even more. For this reason, new lines of research have been undertaken which, in the oncology field, aim at developing increasingly specific therapies against target receptors. Research efforts are also being multiplied to achieve regeneration of the degenerated intervertebral disc and to develop implants with characteristics increasingly similar to those of bone in order to improve mechanical stability and durability over time. Photodynamic therapies are being developed for the treatment of infections in order to reduce the use of antibiotic therapies. Finally, innovative lines of research are being launched to treat and regenerate damaged nerve structures with the goal, still far from today, of making patients with spinal cord injuries to walk


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_4 | Pages 48 - 48
1 Mar 2021
AlSaleh K Aldawsari K Alsultan O Awwad W Alrehaili O
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Posterior spinal surgery is associated with a significant amount of blood loss. The factors predisposing the patient to excessive bleeding-and therefore transfusion- are not well established nor is the effect of transfusion on the outcomes following spinal surgery. We had two goals in this study. First, we were to investigate any suspected risk factors of transfusion in posterior thoraco-lumbar fusion patients. Second, we wanted to observe the negative impact-if one existed- of transfusion on the outcomes of surgery. All adults undergoing posterior thoraco-lumbar spine fusion in our institution from May 2015 to May 2018 were included. Data collected included demographic data as well as BMI, preoperative hemoglobin, American Society of Anesthesiologists classification (ASA), delta Hemoglobin, estimated blood loss, incidence of transfusion, number of units transfused, number of levels fused, length of stay and re-admission within 30 days. The data was analyzed to correlate these variables with the frequency of transfusion and then to assess the association of adverse outcomes with transfusion. 125 patients were included in the study. Only 6 patients (4.8%) required re-admission within the first 30 days after discharge. Length of stay averaged 8.4 days (3–74). 18 patients (14.4%) required transfusion peri-operatively. When multiple variables were analyzed for any correlation, the number of levels fused, age and BMI had statistically significant correlation with the need for transfusion (P <0.005). Patients undergoing posterior thoraco-lumbar fusion are more likely to require blood transfusion if they were older, over-weight & obese or had a multi-level fusion. Receiving blood transfusion is associated with increased complication rates


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_2 | Pages 73 - 73
1 Mar 2021
Murphy B McCabe J
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Abstract. Objective. Spinal cord surgery is a technically challenging endeavour with potentially devastating complications for patients and surgeons. Intra-operative neurophysiological monitoring(IONM), or spinal cord monitoring (SCM), is one method of preventing and identifying damage to the spinal cord. At present, indications for its use are based more on individual surgeon preference and for medico legal purposes. Our study aimed to determine IONM's utility as a clinical tool. Methods. This is a retrospective case series of 169 patients who underwent spinal surgery with IONM at two institutions between 2013 and 2018. Signal changes detected were recorded as well as the surgeon's response to these changes. Patients were followed up to one-year post-surgery using our institution's EVOLVE system. The main outcome measure in this study was new post-operative neurological signs and/or symptoms and what effect, if any, IONM and subsequent surgeon intervention had on these complications. Result. Indications for IONM included cervical stenosis, cervical disc prolapse, unstable fractures and bony metastases. Signal changes were observed in 33% (n=55) of cases. 24 of these patients responded to re-positioning. There were 7 total complications with full resolution by 12 months. False negative rate was 2.4% (n=4). There was one true positive. The largest cohort of patients included those who experienced no signal changes and subsequently no post-operative deficits (n=124). Conclusion. IONM is a non-invasive clinical tool that may be utilised for medicolegal reasons. Its use as a clinical tool is questionable given its relatively high false negative rate and low false positive rate. Declaration of Interest. (b) declare that there is no conflict of interest that could be perceived as prejudicing the impartiality of the research reported:I declare that there is no conflict of interest that could be perceived as prejudicing the impartiality of the research project


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_13 | Pages 33 - 33
1 Nov 2021
Hartland A Teoh K Rashid M
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Introduction and Objective. Tranexamic acid (TXA) is used across surgical specialties to reduce perioperative bleeding. It has been shown to be effective in trauma, spinal surgery, and lower limb arthroplasty. The aim of this study is to investigate the clinical effectiveness of TXA in all types of shoulder surgery on bleeding and non-bleeding related outcomes. Materials and Methods. This study was registered prospectively on the PROSPERO database (ref: CRD42020185482). A systematic review and meta-analysis of randomised controlled trials (RCTs) investigating intra-operative use of TXA versus placebo in any type of surgery to the shoulder girdle. Electronic databases searched included MEDLINE, EMBASE, PsychINFO, and the Cochrane Library. Risk of bias within studies was assessed using the Cochrane risk of bias v2.0 tool and Jadad score. Certainty of findings were reported using the GRADE approach. The primary outcome was total blood loss. Secondary outcomes included patient reported outcome measures, adverse events, and rate of blood transfusion. Results. Eight RCTs were included in the systematic review and data from 7 of these studies pooled in the meta-analysis. A total of 708 patients were randomized across the studies (406 received TXA, 302 received placebo). Studies included patients undergoing anatomic or reverse total shoulder arthroplasty, open Latarjet surgery, and arthroscopic rotator cuff repair. Pooled analysis demonstrated significant reduction in perioperative bleeding with TXA compared to controls; estimated total blood loss (mean difference [MD], −209.66; 95% CI −389.11 to −30.21; p=0.02), and post-operative blood loss (via drain output) (MD, −84.8ml; 95% CI, −140.04 to −29.56; p=0.003). A mean difference in Visual Analogue Scale (VAS) of 2.93 was noted in favour of TXA (95% CI 0.2 to 5.66; p=0.04). Conclusions. Whilst noting some risk of bias within the studies, TXA was effective in reducing blood loss and pain in shoulder surgery. There may be a benefit of TXA use in both open and arthroscopic shoulder procedures. Larger, low risk of bias, RCTs for specific surgical shoulder procedures are required


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_13 | Pages 54 - 54
1 Nov 2021
Lichtenstein A Ovadia J Albagli A Krespi R Rotman D Lichter O Efrima B
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Introduction and Objective. The coronavirus (Covid-19) pandemic, first identified in China in December 2019, halted daily living with mandatory lockdowns imposed in Israel in March 2020. This halt induced a sedentary lifestyle for most citizens as well as a decreased physical activity time. These are both common risk factors for the development of low back pain (LBP) which is considered a major global medical and economical challenge effecting almost 1 in 3 people and a leading cause of Emergency Department (ED) visits. It is hypothesized that prevalence of minor LBP episodes during the first total lockdown should have increased compared to previous times. However, due to “Covid-19 fear” we expect a decrease in ED visits. We also speculate that rate of visits due to serious spinal illness (causing either immediate hospitalization or spinal surgery within 30-days of presentation) did not change. Materials and Methods. Retrospective study based on patients visiting the ED in Tel Aviv Sourasky Medical Center During the first pandemic stage in 2020 compared to parallel periods in 2018 and 2019 due to LBP. Results. During the first lockdown period on March 11th-April 21st, only 171 patients attended the ED due to non-traumatic LBP compared to more than 330 patients in the corresponding time during the years 2018 and 2019. This represents a statistically significant drop of 52.5% (p-value < 0.01) and 48.7% (p-value < 0.01) in LBP ED visits during the first pandemic lockdown of 2020 compared to 2019 and 2018, respectively. Additionally, there was no significant drop in immediate hospitalization or spine surgeries within 30 days following the ED visit (p-value >0.10 for all analysis types). Conclusions. “Covid-19 fear” was probably the main reason for patients with an LBP episode to stay at home during the Covid-19 massive outbreak. Since no significant change was shown in the more severe cases, it seems that the minor LBP patients were able to contain the episode outside hospital walls. This presents an opportunity for clinicians and policy decisions makers to learn and find ways to improve our care of back pain in the community and to reduce unnecessary burden on EDs and the healthcare system