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Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_7 | Pages 123 - 123
4 Apr 2023
Leggi L Terzi S Asunis E Gasbarrini A
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Infections in spine surgery are relatively common and devastating complications, a significant burden to the patient and the healthcare system. Usually, the treatment of SSIs consists of aggressive and prolonged antibiotic therapy, multiple debridements, and in chronic cases, hardware removal. Infections are correlated with worse subjective outcomes and even higher mortality. Depending on the type of spine surgery, the infection rate has been reported to be as higher as 20%. Recently silver-coated implants have been introduced in spine surgery to reduce the incidence of post-operative infections and to improve implant survivorship. The aim of the present study is to evaluate complications and outcomes in patients treated with silver-coated implants because of spine infection. All consecutive patients who had spine stabilization with a silver-coated implant from 2018 to 2021 were screened for inclusion in the study. Inclusion criteria were: (1) six months of minimum follow-up; (2) previous surgical site infection; hematogenous spondylodiscitis requiring surgical stabilization. Demographic and surgical information were obtained via chart review, all the device-related complications and the reoperation rate were also reported. A total of 57 patients were included in the present study. The mean age was 63.4 years, and there were 36 (63%) males and 21 (37%) females. Among the included cases, 57% were SSIs, 33% were spondylodiscitis, and 9% were hardware mobilization. Comorbidities such as diabetes mellitus, obesity, smoke, and oncological history were significant risk factors. In addition, the organisms cultured were Staphylococcus species in most of the cases. At six months of follow-up, 40% of patients were considered free from infection, while 20% needed multiple surgeries. The present research showed satisfactory results of silver-coated implants for the treatment of spine infection


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_13 | Pages 130 - 130
1 Nov 2021
Giorgino R Luca A Ruberto E Besozzi G Banfi G Peretti G
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Introduction and Objective. Over the past few years, a reorganization of the educational pathways has been promoted with the purpose of optimizing the acquisition of competences and their assessment, so as to reduce the risks to both health care professionals and end users. Virtual reality (VR) has been repeatedly tested, initially as a positive reinforcement for more traditional educational pathways and, more recently, as their potential substitute. The aim of this study was to demonstrate the potentiality of VR simulation training in spine surgery. Materials and Methods. The VR simulator reproduced the lateral lumbar access to the spine. The simulation included a tutorial, the preoperative settings, and the surgical session with different levels of procedural complexity. A total of 10 users were recruited for this study: 3 senior surgeons (group A) and 7 orthopedic residents or junior orthopedic surgeons (group B). Each user completed the simulation twice. Results. The user's age or previous experience with VR technology did not show any relevance. On average, the entire simulation was completed in 24 minutes and 36 seconds. Group B showed an improvement between the 2 attempts in both sessions, the preoperative settings and the surgical simulation. The number of major errors dropped from an average of 5.2 to 1.8 and from an average of 4 (1–6) to 1.4, respectively. The simulation was never interrupted because of technical bugs or adverse effects related to the technology. Conclusions. VR-based training pathways might promote a high standard of care. Our preliminary experience suggests an effective implementation of the traditional coaching process


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_8 | Pages 105 - 105
11 Apr 2023
Buser Z Yoon S Meisel H Hauri D Hsieh P Wang J Corluka S
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Mental disorders in particular depression and anxiety have been reported to be prevalent among patients with spinal pathologies. Goal of the current study was to analyze the relationship of Zung pre- and post-op score to other PROs and length of stay. Secondary outcomes included revision surgery and post-operative infections. Data from the international multicenter prospective spine degenerative surgery data repository, DegenPRO v1.1 (AO Spine Knowledge Forum Degenerative) were utilized. Patients undergoing cervical or lumbar procedure were included. Patient's demographics, Charlson Comorbidity Index, surgical information, Zung score, NDI, pain related PROs and EQ-5D, and complications at surgery and at various post-op time periods. Except for hospital duration, data were analyzed, using multivariable mixed linear models. A robust linear regression model was used to assess the association between Zung score and hospital duration. All models were adjusted for gender and age. 42 patients had Zung score administered. Among those patients 22 (52%) were within normal range, 18 (43%) were mildly and 2 (5%) severely depressed. 62% of the patients had a lumbar pathology with fusion procedures being the most common. Median EQ-5D (3L) score at surgery was significantly higher (0.7, IQR: 0.4-0.7) for patients within normal range than for those with mild (0.4, IGR: 0.3-0.7) or severe depression (0.3, IQR: 0.3-0.3, p-value: 0.05). Compared to patients within normal Zung range, mixed models, indicated lower EQ-5D (3L) score values and higher values for neck and arm pain at surgery with both PROs and EQ-5D (3L) improving in patients with depression over the follow-up time. No association was found between Zung score and hospital length of stay. The initial analysis showed that 43% of the patients were mildly depressed and mainly male patients. Zung score was correlated with post-operative improvements in EQ-5D and arm and neck pain PROs


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_17 | Pages 25 - 25
1 Apr 2013
Mannion AF Fekete TF Mutter U Porchet F Kleinstück F Jeszenszky D
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Background/Purpose of study. The increasing aging of the population will see a growing number of patients presenting for spine surgery with appropriate indications but numerous medical comorbidities. This complicates decision-making, requiring that the likely benefit of surgery (outcome) be carefully weighed up against the potential risk (complications). We assessed the influence of comorbidity on the risks and benefits of spine surgery. Methods. 3′699 patients with degenerative lumbar disorders, undergoing surgery with the goal of pain relief, completed the multidimensional Core Outcome Measures Index (COMI; scored 0–10) before and 12 months after surgery. At 12mo they also rated the global treatment outcome and their satisfaction. Using the Eurospine Spine Tango Registry, surgeons documented surgical details, American Society of Anesthesiologists (ASA) scores and surgical/general complications. Results. 29.8% patients were rated ASA1 (normal healthy), 44.8% ASA2 (mild/moderate systemic disease), 25.0% ASA3 (severe) and 0.4% ASA4 (life-threatening). In going from ASA1 to ASA3 (ASA4 group too small), surgical complications increased significantly from 3.6% to 11.1% and general complications increased from 2.3% to 12.6%; 12-month outcomes showed a corresponding decline, with a good global outcome being reported by 78% ASA1 patients, 76% ASA2, and 68% ASA3. Satisfaction with treatment was 87%, 85%, and 79%, respectively and reduction in COMI, 4.2±2.9, 3.7±3.0, and 3.3±3.0 points, respectively. Conclusion. The negative impact of comorbidity on the outcome of spine surgery has not been well investigated/quantified to date. The ASA grade may be helpful in producing algorithms for decision-making and preoperative counselling regarding the corresponding risks and benefits of surgery. No Conflict 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. 104-B, Issue SUPP_14 | Pages 41 - 41
1 Dec 2022
Konstantinos M Leggi L Ciani G Scarale A Boriani L Vommaro F Brodano GB Gasbarrini A
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Recently, there is ongoing evidence regarding rapid recovery after orthopaedic surgery, with advantages for the patient relative to post operative pain, complications and functional recovery. The aim of this study is to present our experience in rapid recovery for adolescent idiopathic scoliosis in the last 2 years.

Retrospective study of 36 patients with adolescent idiopathic scoliosis, (age range 11 to 18 years) treated with spinal thoraco-lumbar posterior fusion with rapid post-operative recovery, compared with a similar group, treated with traditional protocol.

We found a statistically significant difference in terms of length-of-stay, patient-controlled-analgesia and use of oppioid and post operative blood transfusions. There was no difference in post operative infection rate.

Our experience shows better functional recovery, satisfactory controlled analgesia and reduction in costs of hospitalization with the use of ERAS protocols.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_9 | Pages 91 - 91
1 May 2017
Karakasli A Sekik E Karaaslan A Ertem F Kızmazoğlu C Havitcioglu H
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Background. While the biomechanical properties of trans-pedicular screws have proven to be superior in the lumbar spine, little is known concerning pullout strength of trans-pedicle screws in comparison to different distal terminal constructs like sublaminar hooks alone, trans pedicular screws with sublaminar hooks and clow hooks alone in the thoracolumbar spine surgery. In vitro biomechanical pullout testing was performed to evaluate the axial pullout strength of four different distal terminal constructs in thoracolumbar spine surgery. Methods. 32 fresh-frozen lamb spines were used. The lamb spines were divided into four groups, each group is composed of eight lamb spine cadavers with a different distal fixation pattern was used to terminate the construct at L1. (Group 1) trans-pedicular screws alone, (Group 2) sublaminar hooks alone, (Group 3) trans-pedicular screws augmented with a sublaminar hooks via a domino connector and (Group 4) clow hooks alone. Results. The average pullout strength of group 1 was 927N, group2 was 626N, group 3 was 988N and group 4 was 972N. Group 3 and 4 showed the most significant pullout forces when compared to group 1 and group 2. However Group 3 and group 4 didn't show any significant statistical difference when compared to each others. Conclusion. Our study thus suggests that the strongest construct that may reduce the pullout phenomina in the distal fixation constructs are the trans-pedicular screw with laminar hooks. It is strongly advised to be used in osteoporotic bones and in conditions where pullout strength is required to be enhanced. But farther prospective clinical studies are needed to clearly demonstrate the beneficial effect of a trans-pedicular screw augmented with a laminar hooks in reducing the risk of distal instrumentation pullout. Level of Evidence. Level 5. Disclosure. The authors declare that no conflict of interests were associated with the present study


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_4 | Pages 14 - 14
1 Jan 2013
Mannion A Fekete F Kleinstueck F Mutter U Lattig F Porchet F Jeszenszky D Grob D
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Background. Recent years have witnessed a paradigm shift in the assessment of outcome in spine surgery, with patient-centred questionnaires replacing traditional surgeon-based assessments. The assessment of “complications” — loosely defined as new/unexpected problems arising as a result of surgery — has not enjoyed this same enlightened approach. Methods. Patients with lumbar degenerative disorders operated with the goal of pain relief, completed a questionnaire 1 year post-operatively enquiring about complications arising as a consequence of their operation. They rated the bothersomeness of any such complications on a 5-point adjectival scale. Global outcome of surgery and satisfaction were rated on 5-point Likert scales. Results. Of 2946 (92% compliance) patients completing the questionnaire, 861 (29%) reported complications, most commonly sensory disturbances (37% of those with complications) or ongoing pain (22%), followed by motor problems (9%), pain plus sensory disturbances (8%), and problems with wound healing (6%). The corresponding “bothersomeness” ratings for these were: 1% not at all, 23% slightly, 26% moderately, 31% very, and 19% extremely bothersome. Bothersomeness was significantly correlated with global outcome (Rho=0.51, p<0.0001) and satisfaction (Rho=0.43, p<0.0001). A good global outcome was reported by 80% of patients with no complications and only 58% of those with complications; satisfaction was 88% and 72%, respectively. Conclusion. Most complications reported by the patient are perceived to be at least moderately bothersome and are hence not inconsequential. Complications and their severity should be assessed from both the patient's and the surgeon's perspective — not least to better understand the reasons for poor outcome and dissatisfaction with treatment. Conflicts of Interest. None. Source of Funding. None


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_11 | Pages 220 - 220
1 Jul 2014
Blair-Pattison A Henke J Penny G Hu R Swamy G Anglin C
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Summary Statement. Incorrect pedicle screw placement can lead to neurological complications. Practice outside the operating room on realistic bone models, with force feedback, could improve safety. Pedicle forces in cadaveric specimens are reported, to support development of a training tool for residents. Introduction. Inserting screws into the vertebral pedicles is a challenging step in spinal fusion and scoliosis surgeries. Errors in placement can lead to neurological complications and poor mechanical fixation. The more experienced the surgeon, the better the accuracy of the screw placement. A physical training system would provide orthopaedic residents with the feel of performing pedicle cannulation before operating on a patient. The proposed system consists of realistic bone models mimicking the geometry and material properties of typical patients, coupled with a force feedback probe. The purpose of the present study was to determine the forces encountered during pedicle probing to aid in the development of this training system. Methods. We performed two separate investigations. In the first study, 15 participants (9 expert surgeons, 3 fellows, 3 residents) were asked to press a standard pedicle awl three times onto a mechanical scale, blinded to the force, demonstrating what force they would apply during safe pedicle cannulation and during unsafe cortical breach. In the second study, three experienced surgeons used a standard pedicle awl fitted with a one-degree of freedom load cell to probe selected thoracolumbar vertebrae of eight cadaveric specimens to measure the forces required during pedicle cannulation and deliberate breaching, in randomised order. A total of 42 pedicles were tested. Results. Both studies had wide variations in the results, but were in general agreement. Cannulation (safe) forces averaged approximately 90 N (20 lb) whereas breach (unsafe) forces averaged approximately 135–155 N (30–35 lb). The lowest average forces in the cadaveric study were for pedicle cannulation, averaging 86 N (range, 23–125 N), which was significantly lower (p<0.001) than for anterior breach (135 N; range, 80–195 N); medial breach (149 N; range, 98–186 N) and lateral breach (157 N; range, 114–228 N). There were no significant differences among the breach forces (p>0.1). Cannulation forces were on average 59% of the breach forces (range, 19–84%) or conversely, breach forces were 70% higher than cannulation forces. Discussion. To our knowledge, axial force data have not previously been reported for pedicle cannulation and breaching. A large range of forces was measured, as is experienced clinically. Additional testing is planned with a six-degree-of-freedom load cell to determine all of the forces and moments involved in cannulation and breaching throughout the thoracolumbar spine. These results will inform the development of a realistic bone model as well as a breach prediction algorithm for a physical training system for spine surgery. The opportunity to learn and practice outside of the operating room, including learning from deliberate mistakes, should increase the confidence and comprehension of residents performing the procedure, enhance patient safety, reduce surgical time, and allow faster progression of learning inside the operating room


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_1 | Pages 69 - 69
1 Jan 2017
Parchi P Andreani L Cutolo F Carbone M Ferrari V Ferrari M Lisanti M
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Aim of the study was the evaluation of the efficacy of the use of a new wearable AR video see-throught system based on Head Mounted Displays (HMDs) to guide the position of a working cannula into the vertebral body through a transpedicular approach without the use X-Ray images guidance.

We describe a head mounted stereoscopic video see-through display that allows the augmentation of video frames acquired by two cameras with the rendering of patient specific 3D models obtained on the basis of pre-operative radiological volumetric images. The system does not employ any external tracker to detect movements of the user or of the patient. User's head movements and the consistent alignment of the virtual patient with the real one, are accomplished through machine vision methods applied on pairs of live images.

Our system has been tested on an experimental setup that simulate the reaching of lumbar pedicle as in a vertebral augmentation procedure avoiding the employment of ionizing radiation. Aim of the study is to evaluate the ergonomics and the accurancy of the systems to guide the procedure. We performed 4 test sessions with a total of 32 kirschner wire implanted by a single operator wearing the HMD with the AR guide. The system accurancy was evaluated by a post-operative CT scan.

The most ergonomic AR visualization comprise the use of a pair of virtual viewfinders (one at the level of the skin entry point and one at the level of the trocar's bottom) aligned according to the planned direction of the trocar insertion. With such AR guide the surgeon must align the tip of the needle to the center of the first viewfinder placed on the patient's skin. indeed the viewfinder barycenter provides a 2 degrees of freedom (DoFs) positioning guide corresponding to the point of insertion preoperatively planned over the external surface of the model. The second viewfinder is used by the surgeon to rotate and align the trocar according to the planned direction of insertion (2 rotational DOFs). After the first test series a clamping arm has been introduced to maintain the reached trocar's trajectory.

The post-operative CT scan was registered to the preoperative one and the trajectories obtained with the AR guide were compared to the planned one. The overal results obtained in the 4 test session show a medium error of 1.18+/−0.16 mm.

In the last year there was a growing interest to the use of Augmented Reality systems in which the real scene watched by the surgeon is merged with virtual informations extracted from the patient's medical dataset (medical data, patient anatomy, preoperative plannig). Wearable Augmented Reality (WAR) with the use of HDMs allows the surgeon to have a “natural point of view” of the surgical field and of the patient's anatomy avoiding the problems related to eye-hand coordination.

Results of the in vitro tests are encouraging in terms of precision, system usability and ergonomics proving our system to be worthy of more extensive tests.


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_16 | Pages 33 - 33
1 Dec 2021
Kakadiya G Chaudhary K
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Abstract. Objectives. to evaluate the efficacy and safety of topically applied tranexamic acid (TXA) in thoracolumbar spinal tuberculosis surgery, posterior approach. Methods. Thoracolumbar spine tuberculosis patients who requiring debridement, pedicle screw fixation and fusion surgery were divided into two groups. In the TXA group (n=50), the wound surface was soaked with TXA (1 g in 100 mL saline solution) for 3 minutes after exposure, after decompression, and before wound closure, and in the control group (n=116) using only saline. Intraoperative blood loss, drain volume 48 hours after surgery, amount of blood transfusion, transfusion rate, the haemoglobin, haematocrit after the surgery, the difference between them before and after the surgery, incision infection and the incidence of deep vein thrombosis between the two groups. Results. EBL for the control group was 783.33±332.71 mL and for intervention group 410.57±189.72 mL (p<0.001). The operative time for control group was 3.24±0.38 hours and for intervention group 2.99±0.79 hours (p<0.695). Hemovac drainage on days1 and 2 for control group was 167.10±53.83mL and 99.33±37.5 mL, respectively, and for intervention group 107.03±44.37mL and 53.38±21.99mL, respectively (p<0.001). The length of stay was significantly shorter in the intervention group (4.8±1.1 days) compared to control group (7.0±2.3 days). There was bo different in incision side infection and DVT. Conclusions. Topical TXA is a viable, cost-effective method of decreasing perioperative blood loss in major spine surgery with fewer overall complications than other methods. Further studies are required to find the ideal dosage and timing


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. 106-B, Issue SUPP_1 | Pages 11 - 11
2 Jan 2024
Petrucci G Papalia GF Russo F Ambrosio L Papalia R Vadalà G Denaro V
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Chronic low back pain (CLBP) is the most common cause of disability worldwide, and lumbar spine fusion (LSF) is often chosen to treat pain caused by advanced degenerative disease when clinical treatment failed certain cases, the post-surgical outcomes are not what was expected. Several studies highlight how important are. In psychological variables during the postoperative spine surgery period. The aim of this study is to assess the role of preoperative depression on postoperative clinical outcomes. We included patients who underwent LSF since December 2021. Preoperative depression was assessed administering Beck Depression Inventory questionnaire (BDI). And pain and disability were evaluated at 1, 3, and 6 months, administering respectively Visual Analogic Scale (VAS) and Oswestry Disability Index (ODI). As statistical analysis Mann-Whitney test was performed. We included 46 patients, 20 female (43,5%) and 26 male (56,5%) with an average age of 64,2. The population was divided in two groups, fixing the BDI cut-off point at 10. Patients with BDI < 10 points (N=28) had normal mental health status, instead patients with BDI > 10 points (N=16) had depressive disorders. At 3 months patients with healthy mental status reported statistically significant reduction of pain (U = 372,5, p = .006) and improvement of disability but without statistical significancy (U = 318, p = 0,137). At 6 months patients without psychological disease reported statistically significant reduction of pain (U = 342, p = 0,039) and disability (U = 372,5, p = 0,006). This study demonstrates the correlation between pre-existing depressive state and poorer clinical outcomes after spine surgery. These results are consistent with the literature. Therefore, during the surgical decision making it is crucial to take psychological variables into account in order to predict the results after surgery and inform patients on the potential influence of mental status


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. 106-B, Issue SUPP_2 | Pages 131 - 131
2 Jan 2024
Vadalà G
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Infections are among the most diffused complications of the implantation of medical devices. In orthopedics, they pose severe societal and economic burden and interfere with the capability of the implants to integrate in the host bone, significantly increasing failure risk. Infection is particularly severe in the case of comorbidities and especially bone tumors, since oncologic patients are fragile, have higher infection rate and impaired osteoregenerative capabilities. For this reason, prevention of infection is to be preferred over treatment. This is even more important in the case of spine surgery, since spine is among the main site for tumor metastases and because incidence of post operative surgical-site infections is significant (up to 15-20%) and surgical options are limited by the need of avoiding damaging the spinal cord. Functionalization of the implant surfaces, so as to address infection and, possibly, co- adjuvate anti-tumor treatments, appears as a breakthrough innovation. Unmet clinical needs in infection and tumors is presented, with a specific focus on the spine, then, new perspectives are highlighted for their treatment


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_1 | Pages 4 - 4
2 Jan 2024
Kucko N Sage K Delawi D Hoebink E Kempen D Van Susante J de Bruijn J Kruyt M
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Pseudoarthrosis after spinal fusion is an important complication leading to revision spine surgeries. Iliac Crest Bone Graft is considered the gold standard, but with limited availability and associated co-morbidities, spine surgeons often utilize alternative bone grafts. Determine the non-inferiority of a novel submicron-sized needle-shaped surface biphasic calcium phosphate (BCP<µm) as compared to autograft in instrumented posterolateral spinal fusion. Adult patients indicated for instrumented posterolateral spinal fusion of one to six levels from T10-S2 were enrolled at five participating centers. After instrumentation and preparation of the bone bed, the randomized allocation side of the graft type was disclosed. One side was grafted with 10cc of autograft per level containing a minimum of 50% iliac crest bone. The other side was grafted with 10cc of BCP<µm granules standalone (without autograft or bone marrow aspirate). In total, 71 levels were treated. Prospective follow-up included adverse events, Oswestry Disability Index (ODI), and a fine-cut Computerized Tomography (CT) at one year. Fusion was systematically scored as fused or not fused per level per side by two spine surgeons blinded for the procedure. The first fifty patients enrolled are included in this analysis (mean age: 57 years; 60% female and 40% male). The diagnoses included deformity (56%), structural instability (28%), and instability from decompression (20%). The fusion rate determined by CT for BCP<μm was 76.1%, which compared favorably to the autograft fusion rate of 43.7%. Statistical analysis through binomial modeling showed that the odds of fusion of BCP<μm was 2.54 times higher than that of autograft. 14% of patients experienced a procedure or possible device-related severe adverse event and there were four reoperations. Oswestry Disability Index (ODI) score decreased from a mean of 46.0 (±15.0) to a mean of 31.7 (±16.9), and 52.4% of patients improved with at least 15-point decrease. This data, aiming to determine non-inferiority of standalone BCP<μm as compared to autograft for posterior spinal fusions, is promising. Ongoing studies to increase the power of the statistics with more patients are forthcoming


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_18 | Pages 48 - 48
14 Nov 2024
Vadalà G Papalia GF Russo F Nardi N Ambrosio L Papalia R Denaro V
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Introduction. Intraoperative navigation systems for lumbar spine surgery allow to perform preoperative planning and visualize the real-time trajectory of pedicle screws. The aim of this study was to evaluate the deviation from preoperative planning and the correlations between screw deviation and accuracy. Method. Patients affected by degenerative spondylolisthesis who underwent posterior lumbar interbody fusion using intraoperative 3D navigation since April 2022 were included. Intraoperative cone-beam computed tomography (CBCT) was performed before screw planning and following implantation. The deviation from planning was calculated as linear, angular, and 3D discrepancies between planned and implanted screws. Accuracy and facet joint violation (FJV) were evaluated using Gertzbein-Robbins system (GRS) and Yson classification, respectively. Statistical analysis was performed using SPSS version28. One-way ANOVA followed by Bonferroni post-hoc tests were performed to evaluate the association between GRS, screw deviation and vertebral level. Statistical significance was set at p<0.05. Result. This study involved 34 patients, for a total of 154 pedicle screws. Mean age was 62.6±8.9 years. The mean two-dimensional screw tip deviation in mediolateral (ML), craniocaudal (CC), and anteroposterior (AP) was 2.6±2.45mm, 1.6±1.7mm, and 3.07±2.9mm, respectively. The mean screw tip 3D deviation was 5±3.3mm. The mean two-dimensional screw head deviation in ML, CC and AP was 1.83±1.8mm, 1.7±1.67mm and 3.6±3.1mm, respectively. The mean screw head 3D deviation was 4.94±3.2mm. 98% of screws were clinically acceptable (grade A+B), and grade 0 for FJV. Significant results were found between GRS and ML (p=0.005), AP (p=0.01) and 3D (p=0.003) tip deviations, and between GRS and AP and 3D head deviations (both p=0). Moreover, a significant correlation was found between GRS and vertebral level (p=0). Conclusion. Our results showed a reasonable rate of discrepancy between planned and positioned screws. However, accuracy was clinically acceptable in almost all cases. Therefore, pedicle screw fixation using intraoperative CBCT, 3D navigation and screw planning is safe and accurate


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_18 | Pages 23 - 23
14 Nov 2024
Ambrosio L Schol J Fernández CR Papalia R Vadalà G Denaro V Sakai D
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Introduction. Intervertebral disc degeneration (IDD) is a progressive process affecting all disc tissues, namely the nucleus pulposus (NP), annulus fibrosus (AF), and cartilaginous endplates (CEPs). Several cell-based therapies have been proposed to replenish the disc cell population and promote tissue regeneration. However, cell-free therapeutics have been increasingly explored due to potentially higher advantages and cost-effectiveness compared to cell transplantation. Recently, extracellular vesicles (EVs) isolated from healthy Tie2. +. -NP cells (NPCs) have shown promising regenerative outcomes on degenerative NPCs (dNPCs). The aim of this study was to assess the effect of such EVs on all disc cell types, including AF cells (AFCs) and CEP cells (CEPCs), compared to EVs isolated from bone-marrow derived mesenchymal stromal cells (BM-MSCs). Method. NPCs harvested from young donors underwent an optimized culture protocol to maximize Tie2 expression (NPCs. Tie2+. ). BM-MSCs were retrieved from a commercial cell line or harvested during spine surgery procedures. EV characterization was performed via particle size analysis (qNano), expression of EV markers (Western blot), and transmission electron microscopy. dNPCs, AFCs, and CEPCs were isolated from surgical specimens of patients affected by IDD, culture-expanded, and treated with NPCs. Tie2+. -EVs or BM-MSC-EVs ± 10 ng/mL IL-1b. EV uptake was assessed with PKH26 staining of EVs under confocal microscopy. Cell proliferation and viability were assessed with the CCK-8 assay. Result. Upon characterization, isolated EVs exhibited the typical exosomal characteristics. NPCs. Tie2+. -EVs and BM-MSC-EVs uptake was successfully observed in all dNPCs, AFCs, and CEPCs. Both EV products significantly increased dNPC, AFC, and CEPC viability, especially in samples treated with NPCs. Tie2+. -EVs. Conclusion. NPCs. Tie2+. -EVs demonstrated to significantly stimulate the proliferation and viability of degenerative cells isolated from all disc tissues. Rather than the sole NP, EVs isolated by committed progenitors physiologically residing within the disc may exert their regenerative effects on the whole organ, thus possibly constituting the basis for a new therapy for IDD


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_14 | Pages 35 - 35
1 Dec 2022
Montanari S Griffoni C Cristofolini L Brodano GB
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Mechanical failure of spine posterior fixation in the lumbar region Is suspected to occur more frequently when the sagittal balance is not properly restored. While failures at the proximal extremity have been studied in the literature, the lumbar distal junctional pathology has received less attention. The aim of this work was to investigate if the spinopelvic parameters, which characterize the sagittal balance, could predict the mechanical failure of the posterior fixation in the distal lumbar region. All the spine surgeries performed in 2017-2019 at Rizzoli Institute were retrospectively analysed to extract all cases of lumbar distal junctional pathology. All the revision surgeries performed due to the pedicle screws pull-out, or the breakage of rods or screws, or the vertebral fracture, or the degenerative disc disease, in the distal extremity, were included in the junctional (JUNCT) group. A total of 83 cases were identified as JUNCT group. All the 241 fixation surgeries which to date have not failed were included in the control (CONTROL) group. Clinical data were extracted from both groups, and the main spinopelvic parameters were assessed from sagittal standing preoperative (pre-op) and postoperative (post-op) radiographs with the software Surgimap (Nemaris). In particular, pelvic incidence (PI), sagittal vertical axis (SVA), pelvic tilt (PT), T1 pelvic angle (TPA), sacral slope (SS) and lumbar lordosis (LL) have been measured. In JUNCT, the main failure cause was the screws pull-out (45%). Spine fixation with 7 or more levels were the most common in JUNCT (52%) in contrast to CONTROL (14%). In CONTROL, PT, TPA, SS and PI-LL were inside the recommended ranges of good sagittal balance. For these parameters, statistically significant differences were observed between pre-op and post-op (p<0.0001, p=0.01, p<0.0001, p=0.004, respectively, Wilcoxon test). In JUNCT, the spinopelvic parameters were out of the ranges of the good sagittal balance and the worsening of the balance was confirmed by the increase in PT, TPA, SVA, PI-LL and by the decrease of LL (p=0.002, p=0.003, p<0.0001, p=0.001, p=0.001, respectively, paired t-test) before the revision surgery. TPA (p=0.003, Kolmogorov-Smirnov test) and SS (p=0.03, unpaired t-test) differed significantly in pre-op between JUNCT and CONTROL. In post-op, PI-LL was significantly different between JUNCT and CONTROL (p=0.04, unpaired t-test). The regression model of PT vs PI was significantly different between JUNCT and CONTROL in pre-op (p=0.01, Z-test). These results showed that failure is most common in long fused segments, likely due to long lever arms leading to implant failure. If the sagittal balance is not properly restored, after the surgery the balance is expected to worsen, eventually leading to failure: this effect was confirmed by the worsening of all the spinopelvic parameters before the revision surgery in JUNCT. Conversely, a good sagittal balance seems to avoid a revision surgery, as it is visible is CONTROL. The mismatch PI-LL after the fixation seems to confirm a good sagittal balance and predict a good correction. The linear regression of PT vs PI suggests that the spine deformity and pelvic conformation could be a predictor for the failure after a fixation


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_13 | Pages 122 - 122
1 Nov 2021
Meisel H
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AO Spine Guideline for Using Osteobiologics in Spine Degeneration project is an international collaborative initiative to identify and evaluate evidence on existing use of osteobiologics in spine degenerative diseases. It aims to formulate clinically relevant and internationally applicable guidelines ensuring evidence-based, safe and effective use of osteobiologics. The current focus is the use of osteobiologics in anterior cervical discectomy and fusion surgeries. The guideline development is planned in three phases. Phase 1- Evidence synthesis and Recommendation; Phase 2- Guideline with osteobiologics grading and Validation; Phase 3- Guideline dissemination and Development of a clinical decision support tool. The key questions formulating the guidelines for the use of osteobiologics will be addressed in a series of systematic reviews in Phase 1. The evidence synthesized by the systematic reviews will be assessed by Grading of Recommendations, Assessment, Development and Evaluations (GRADE) methodology, including expert panel discussions to formulate a recommendation. In Phase 2, osteobiologics will be graded based on evidence and the grading will be integrated with the recommendation from Phase 1, and thus formulate a guideline. The guideline will be further validated by prospective clinical studies. In the third phase, dissemination of the proposed guideline and development of a decision support tool is planned. AO-GO aims to bridge an important gap between quality of evidence and use of osteobiologics in spine fusion surgeries. With a holistic approach the guideline aims to facilitate evidence-based, patient-oriented decision-making process in clinical practice, thus stimulating further evidence-based studies regarding osteobiologics usage in spine surgeries


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