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Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_8 | Pages 101 - 101
11 Apr 2023
Brodano G Griffoni C Facchini G Carretta E Salamanna F Tedesco G Evangelisti G Terzi S Ghermandi R Bandiera S Girolami M Pipola V Fini M Gasbarrini A Leggi L
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Aneurysmal bone cyst (ABC) of the spine is a locally aggressive benign lesion which can be treated by en bloc resection with wide margin to reduce the risk of local recurrence. To avoid morbidity associated with surgery, selective arterial embolization (SAE) can be considered the first-line treatment for ABCs of the spine. We previously introduced the use of autologous bone marrow concentrate (BMC) injection therapy to stimulate bone healing and regeneration in ABC of the spine. In this prospective study we described the clinical and radiological outcomes of percutaneous injection of autologous BMC in a series of patients affected by ABCs of the spine.

Fourteen patients (6 male, 8 female) were treated between June 2014 and December 2019 with BMC injection for ABC of the spine. The mean age was 17.85 years. The mean follow up was 37.4 months (range 12–60 months). The dimension of the cyst and the degree of ossification were measured by Computed Tomography (CT) scans before the treatment and during follow-up visits.

Six patients received a single dose of BMC, five patients received two doses and in three patients three doses of BMC were administered. The mean ossification of the cyst (expressed in Hounsfield units) increased statistically from 43.48±2.36 HU to 161.71±23.48 HU during follow-up time and the ossification was associated to an improvement of the clinical outcomes. The mean ossification over time was significantly higher in patients treated with a single injection compared to patients treated with multiple injections. No significant difference in ossification was found between cervical and non-cervical localization of the cyst. Moreover, the initial size of the cyst was not statistically associated with the degree of ossification during follow-up.

The results of this study reinforce our previous evidence on the use of BMC as a valid alternative for spinal ABC management when SAE is contraindicated or ineffective.

The initial size of the cyst and its localization does not influence the efficacy of the treatment. However, data suggest that BMC injection could be indicated as treatment of choice for spinal ABC in young adolescent women.


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. 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. 104-B, Issue SUPP_14 | Pages 37 - 37
1 Dec 2022
Contartese D Salamanna F Borsari V Pagani S Sartori M Martini L Brodano GB Gasbarrini A Fini M
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Breast cancer is the most frequent malignancy in women with an estimation of 2.1 million new diagnoses in 2018. Even though primary tumours are usually efficiently removed by surgery, 20–40% of patients will develop metastases in distant organs. Bone is one of the most frequent site of metastases from advanced breast cancer, accounting from 55 to 58% of all metastases. Currently, none of the therapeutic strategies used to manage breast cancer bone metastasis are really curative. Tailoring a suitable model to study and evaluate the disease pathophysiology and novel advanced therapies is one of the major challenges that will predict more effectively and efficiently the clinical response. Preclinical traditional models have been largely used as they can provide standardization and simplicity, moreover, further advancements have been made with 3D cultures, by spheroids and artificial matrices, patient derived xenografts and microfluidics. Despite these models recapitulate numerous aspects of tumour complexity, they do not completely mimic the clinical native microenvironment. Thus, to fulfil this need, in our study we developed a new, advanced and alternative model of human breast cancer bone metastasis as potential biologic assay for cancer research. The study involved breast cancer bone metastasis samples obtained from three female patients undergoing wide spinal decompression and stabilization through a posterior approach. Samples were cultured in a TubeSpin Bioreactor on a rolling apparatus under hypoxic conditions at time 0 and for up to 40 days and evaluated for viability by the Alamar Blue test, gene expression profile, histology and immunohistochemistry. Results showed the maintenance and preservation, at time 0 and after 40 days of culture, of the tissue viability, biological activity, as well as molecular markers, i.e. several key genes involved in the complex interactions between the tumour cells and bone able to drive cancer progression, cancer aggressiveness and metastasis to bone. A good tis sue morphological and microarchitectural preservation with the presence of lacunar osteolysis, fragmented trabeculae locally surrounded by osteoclast cells and malignant cells and an intense infiltration by tumour cells in bone marrow compartment in all examined samples. Histomorphometrical data on the levels of bone resorption and bone apposition parameters remained constant between T0 and T40 for all analysed patients. Additionally, immunohistochemistry showed homogeneous expression and location of CDH1, CDH2, KRT8, KRT18, Ki67, CASP3, ESR1, CD8 and CD68 between T0 and T40, thus further confirming the invasive behaviour of breast cancer cells and indicating the maintaining of the metastatic microenvironment. The novel tissue culture, set-up in this study, has significant advantages in comparison to the pre-existent 3D models: the tumour environment is the same of the clinical scenario, including all cell types as well as the native extracellular matrix; it can be quickly set-up employing only small samples of breast cancer bone metastasis tissue in a simple, ethically correct and cost-effective manner; it bypasses and/or decreases the necessity to use more complex preclinical model, thus reducing the ethical burden following the guiding principles aimed at replacing/reducing/refining (3R) animal use and their suffering for scientific purposes; it can allow the study of the interactions within the breast cancer bone metastasis tissue over a relatively long period of up to 40 days, preserving the tumour morphology and architecture and allowing also the evaluation of different biological factors, parameters and activities. Therefore, the study provides for the first time the feasibility and rationale for the use of a human-derived advanced alternative model for cancer research and testing of drugs and innovative strategies, taking into account patient individual characteristics and specific tumour subtypes so predicting patient specific responses.


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 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. 104-B, Issue SUPP_14 | Pages 36 - 36
1 Dec 2022
Falzetti L Fermi M Ghermandi R Girolami M Pipola V Presutti L Gasbarrini A
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Chordoma of the cervical spine is a rare but life-threatening disease with a relentless tendency towards local recurrence. Wide en bloc resection is recommended, but it is frequently not feasible in the cervical spine. Radiation therapy including high-energy particle therapy is commonly used as adjuvant therapy. The goal of this study was to examine treatment and outcome of patients with chordoma of the cervical spine.

Patients affected by cervical spine chordoma who underwent surgery at the Rizzoli Institute and University Hospital of Modena, between 2007 and 2021 were identified. The clinical, pathologic, and radiographic data were reviewed in all cases. Patient outcomes including local recurrence and disease-specific survival (DSS) were analyzed using chi-square test and Kaplan-Meier survival analysis.

Characteristics of the 29 patients (10 females; 19 males) included: median age at surgery 52.0 years (IQR 35.5 - 62.5 years), 10 (35%) involved upper cervical spine, 16 (55%) with tumors in the mid cervical spine, and 4 in the lower cervical spine (10%). Median tumor volume was 16 cm3 (IQR 8.7 - 20.8). Thirteen patients (45%) were previously treated surgically while 9 patients (31%) had previous radiation therapy. All patients underwent surgery: en bloc resection was passible in 4 patients (14 %), seventeen patients (59%) were treated with gross total resection while 8 patients (27%) underwent subtotal resection. Tumor volume was associated with a significantly higher risk of intraoperative complications (p < 0.01). Nineteen patients (65%) received adjuvant high-energy particle therapy. The median follow-up was 26 months (IQR 11 - 44). Twelve patients (41%) had local recurrence of disease. Patients treated with adjuvant high-energy particle therapy had a significant higher local control than patients who received photons or no adjuvant treatment (p = 0.01). Recurrence was the only factor significantly associated with worse DSS (p = 0.03 – OR 1.7), being the survival of the group of patients with recurrent disease 58.3% while the survival of the group of patients with no recurrent disease was 100%.

Post-operative high-energy particle therapy improved local control in patients with cervical chordoma after surgical resection. Increased tumor volume was associated with increased risk of intraoperative complications. Recurrence of the disease was the only factor significantly associated with disease mortality.


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. 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. 103-B, Issue SUPP_13 | Pages 84 - 84
1 Nov 2021
Bròdano GB Griffoni C Facchini G Carretta E Salamanna F Tedesco G Evangelisti G Terzi S Ghermandi R Bandiera S Girolami M Pipola V Fini M Gasbarrini A
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Introduction and Objective

Aneurysmal bone cyst (ABC) of the spine is a locally aggressive benign lesion which can be treated by en bloc resection with wide margin to reduce the risk of local recurrence. To avoid morbidity associated with surgery, selective arterial embolization (SAE) can be considered the first-line treatment for ABCs of the spine. Other emerging treatments for ABCs include bisphosphonates, percutaneous doxycycline, sclerotherapy and Denosumab. In addition, we previously introduced the use of autologous bone marrow concentrate (BMC) injection therapy to stimulate bone healing and regeneration in ABC of the spine. One of the potential advantages of such a method is that surgical treatments are not necessary, thus allowing for both a minimally invasive approach and the treatment of poorly accessible lesions. In this prospective study we described the clinical and radiological outcomes of percutaneous injection of autologous BMC in a series of patients affected by ABCs of the spine and followed for at least one year.

Materials and Methods

Fourteen patients (6 male, 8 female) were treated between June 2014 to December 2019 with BMC injection for ABC of the spine. The mean age was 17.85 years. The mean follow up was 37.4 months (range 12– 60 months). The dimension of the cyst and the degree of ossification were measured by Computed Tomography (CT) scans before the treatment and during follow-up visits.


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.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_2 | Pages 107 - 107
1 Jan 2017
Girolami M Brodano GB Babbi L Cenacchi A Gasbarrini A Bandiera S Terzi S Ghermandi R Boriani S
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The nature of the Aneurysmal Bone Cyst (ABC) is still controversial among benign tumor, often identifiable in the “aggressive” form (Enneking stage 3) or pseudotumoral lesion. It is well known instead the very high risk of intraoperative bleeding, indicating a strongly unfavorable relationship between the surgical morbidity and the nature of the disease. Recently, excellent results have been obtained in the treatment of ABC by repeated arterial embolizations (SAE), without any surgery, while initial experiences with administration of denosumab and doxycycline are still under study. This study presents the results of our initial experience in the treatment of vertebral ABC through the use of concentrated autologous mesenchymal stem cells (MSCs).

Two teenagers aged 15 years, male, and 14 years, female, came to our attention both with diagnosis of ABC in C2 vertebra which was histologically confirmed. They were both neurologically intact, the girl complained of neck pain. The arteriography showed in both cases close relationships between the pathological ABC vascularization and the vertebral and cervical ascending arteries, making treatment by selective arterial embolization unsuitable. After discussion with the parents of patients, we jointly decided to undertake the treatment by direct injection of MSCs preceded, in the same operative session, by harvesting from the iliac crest of 60 cc of bone marrow (by needle aspiration) and its separation with the use of concentration system Res-Q ™ 60 BMC. In the second case the treatment was repeated two times at distance of 4 months.

The clinical and radiological follow-up is to of 30 months from the first treatment in both cases. In the first case the presence of newly formed bone within the ABC appeared as a clear sign of recovery just a month after the first treatment and increased gradually, until the cyst appeared completely ossified one year after the treatment, with associated disappearance of the pain. In the second case an initial sclerotic peripheral margin appeared after the second treatment and later ossification progressed, concurrently with the disappearance of the pain.

Treatment with selective serial arterial embolization is considered effective in the treatment of ABC even if not without risks, mainly related to the frequent and repeated exposure to ionizing radiation. Furthermore, in a certain percentage of cases the procedure is not technically executable, especially for the presence of arteries afferent to the medullar vascularization. Inconsistent results were obtained with other procedures: the injection of calcitonin, steroid, alcoholic solutions, or the use of sclerosing substances. Radiation therapy, though very effective, it is not considered the first choice. Recently, promising results have been achieved by the injection of mononuclear cells derived from bone marrow in the treatment of Aneurysmal Bone Cyst. Based on the early results obtained in the two cases described, the injection of MSCs can be considered a valid alternative in the treatment of vertebral ABCs untreatable by embolization.


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. 99-B, Issue SUPP_1 | Pages 71 - 71
1 Jan 2017
Barbanti Brodano G Fini M Bandiera S Gasbarrini A Terzi S Ghermandi R Babbi L Girolami M Giavaresi G Boriani S
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Spinal fusion is one of the most common surgical procedures in spine surgery, whose primary objective is the stabilization of the spine for the treatment of many degenerative, traumatic and oncological diseases of the spine. Autologous bone is still considered the “gold standard” technique for spinal fusion. However, biomaterials which are potentially osteogenic, osteoinductive and osteoconductive can be used to increase the process of spinal fusion. We evaluated two new bone substitutes as an alternative to autologous bone for spinal fusion, using an animal model of large size (adult sheep).

A preclinical study was designed to compare the efficacy of SINTlife® Putty and DBSINT® biomaterials with conventional bone autograft in an ovine model of lumbar spine fusion. SINTlife® is a biomaterial made from hydroxyapatite enriched with magnesium ions, resulting to be very similar to natural bone. DBSint® is a paste composite bone, osteo-inductive, pliable and conformable, consisting of demineralized bone matrix (DBM) carried by hydroxyapatite biomimetics. Eighteen adult female sheep were selected for two-levels spine surgical procedures. The animals were divided in two groups: in Group A, one fusion level was treated with SINTlife® Putty and the other level received cortical-cancellous bone autograft; in Group B, one fusion level was treated with DBSINT® and the other level received cortical-cancellous bone autograft. At the end of the experimental time, all the animals were euthanized. The spine segments were analyzed macroscopically, radiographically, microtomographically, histologically and histomorphometrically.

The SINT-Life® Putty shows a perfect osteointegration in all the histological specimens. A high percentage of newly formed bone tissue is detected, with lots of trabeculae having structure and morphology similar to the pre-existing bone. In all the specimens collected from DBSINT®-treated animals the presence of hydroxyapatite alone is reported but not the demineralized bone matrix. The presence of newly formed bone tissue can be detected in all the specimens but newly formed bone shows very thin and irregular trabeculae next to the cartilage zone, while away from the border of ossification there are thicker trabeculae similar to the pre-existing bone.

The use of the experimental biomaterial SINT-Life® Putty in an ovine model of spine fusion leads to the development of newly formed bone tissue without qualitative and quantitative differences with the one formed with autologous bone. The experimental material DBSINT® seems to lead to less deposition of newly formed bone with wider intertrabecular spaces. Following these results, we planned and submitted to the Ethical Committee a clinical study to evaluate the safety and efficacy of SINT-Life® product in comparison to autologous bone, as an alternative treatment for spine fusion procedures.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_1 | Pages 121 - 121
1 Jan 2017
Girolami M Babbi L Gasbarrini A Barbanti Brodano G Bandiera S Terzi S Ghermandi R Boriani S
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Spinal infections are rare diseases, whose management highlights the importance of a multidisciplinary approach. Although treatment is based on antibiotics, always selected on coltural and antibiogram tests, surgery is required in case of development of spinal instability or deformity, progressive neurological deficits, drainage of abscesses, or failure of medical treatment.

The first step of the algorithm is diagnosis, that is established on MRI with contrast, PET/CT scan, blood tests (CRP and ESR) and CT-guided needle biopsy. Evaluation of response to the specific antibiotic therapy is based on variations in Maximum Standardized Uptake Value (SUVmax) after 2 to 4 weeks of treatment. In selected cases, early minimally invasive surgery was proposed to provide immediate stability and avoid bed-rest.

From 1997 to 2014, 182 patients affected by spinal infections have been treated at the same Institution (Istituto Ortopedico Rizzoli – Bologna, Italy) according to the proposed algorithm. Mean age was 56 years (range 1 – 88). Male to female ratio was 1.46.

Minimum follow-up was 1 year. Infections were mostly located in the lumbar spine (57%) followed by thoracic (37%) and cervical spine (6%). Conservative treatment based on antibiotics needed surgery (open and/or percuteneous minimally invasive) as an adjuvant in 83 patients out of 182 (46%).

Management of spinal infections still remains a challenge in spinal surgery and a multisciplinary approach is mandatory. This algorithm represents the shared decision- making process from diagnosis to the most appropriate treatment and it led to successful outcomes with a low-complication rate.

We present this algorithm developed to organize the various professionals involved (orthopaedic surgeons, nuclear medicine and infective disease specialists, interventional radiologists and anaestesiologists) and set a shared pathway of decision making in order to uniform the management of this complex disease.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_1 | Pages 126 - 126
1 Jan 2017
Gasbarrini A Bandiera S Barbanti Brodano G Terzi S Ghermandi R Cheherassan M Babbi L Girolami M Boriani S
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In case of spine tumors, when en bloc vertebral column resection (VCR) is indicated and feasible, the segmental defect should be reconstructed in order to obtain an immediate stability and stimulate a solid fusion. The aim of this study is to share our experience on patients who underwent spinal tumor en bloc VCR and reconstruction consecutively.

En bloc VCR and reconstruction was performed in 138 patients. Oncological and surgical staging were performed for all patients using Enneking and Weinstein-Boriani-Biagini systems accordingly. Following en bloc VCR of one or more vertebral bodies, a 360° reconstruction was made by applying posterior instrumentation and anterior implant insertion. Modular carbon fiber implants were applied in 111 patients, titanium mesh cage implants in 21 patients and titanium expandable cages in 3 patients; very recently in 3 cases we started to use custom made titanium implants. The latter were prepared according to preoperative planning of en bloc VCR based on CT-scan of the patient, using three dimensional printer.

The use of modular carbon fiber implant has not leaded to any mechanical complications in the short and long term follow-up. In addition, due to radiolucent nature of this implant and less artifact production on CT and MRI, tumor relapse may be diagnosed and addressed earlier in compare with other implants, which has a paramount importance in these group of patients. We did not observe any implant failure using titanium cages. However, tumor relapse identification may be delayed due to metal artifacts on imaging modalities.

Custom- made implants are economically more affordable and may be a good alternative choice for modular carbon fiber implants. The biocompatibility of the titanium make it a good choice for reconstruction of the defect when combined with bone graft allograft or autograft. Custom made cages theoretically can reproduce patients own biomechanics but should be studied with longer follow-up.