Factors associated with increased length of stay and risk of complications in 336 patients submitted to spine surgery. The role of a validated capture system (SAVES v2) as a first-line tool to properly face the problem.

PURPOSE: In this study, we analyzed the use of a validated capture system (Spinal Adverse Events Severity system, SAVES V2) as a first non-technical skill to properly face the relevant problem of surgical complications (SCs) and adverse events (AEs) in spinal surgery. METHODS: We retrospectively collected AEs occurring in a tertiary referral center for spine surgery from January 2017 to January 2018 and classified them according to SAVES V2 system. We compared this collection of AEs with a prospective collection performed without any classification system. Univariate and multivariate logistic regression models were used to determined odds ratio (ORs) for selected potential risk factors of AEs and prolonged length of stay. RESULTS: Overall a higher number of AEs was retrospectively recorded using SAVES system compared to the prospective recording without the use of any capture system (97/336 vs 210/336, p < 0.001). The length of stay (LOS) increased in the group of complicated patients for all the procedures examined. In the non-oncological group, LOS was significantly higher for complicated patients compared to uncomplicated patients (F = 44.11, p = 0.0000). Similar results have been obtained in the oncological group of patients. In the multivariate regression model surgical time and postoperative AEs emerged as risk factors for prolonged LOS, while only the presence of previous surgeries was confirmed as risk factor for AEs. CONCLUSION: Considering that the rate of AEs and SCs in spinal surgery is still high despite the improvement of technical skills, we suggest the use of SAVES V2 capture system as a first-line tool to face the problem.

Capacitive biophysical stimulation improves the healing of vertebral fragility fractures: a prospective multicentre randomized controlled trial.

BACKGROUND: Capacitively coupling electric fields (CCEF) is a method of non-invasive biophysical stimulation that enhances fracture repair and spinal fusion. This multicentre randomized controlled trial aimed to further examine the roles of CCEF in (1) the resolution of vertebral bone marrow oedema (VBME) using a follow-up MRI study and (2) pain relief, analgesic drug consumption and quality of life improvement in stimulated patients who were referred with acute vertebral fragility fractures (VFFs) compared to non-stimulated patients. METHODS: Between September 2016 and December 2019, patients who were referred to the spine centres that participated in this multicentre randomized clinical study with acute VFFs of type OF1 or OF2 were included in the present study. All the VFFs were conservatively managed according to Good Clinical Practice. Moreover, the patients were randomized into two groups: the CCEF group received, as an adjunct to the clinical study protocol, biophysical stimulation with a CCEF device (Osteospine, IGEA) for 8 h per day for 60 days, whereas the control group was treated according to the clinical study protocol. At baseline (T0), the 30-day follow-up (T1), the 60-day follow-up (T2), and the 6-month follow-up (T3), each patient underwent clinical evaluation using the Visual Analogue Scale (VAS) for Pain and the Oswestry Disability Index (ODI). Analgesic therapy with paracetamol 1000 mg tablets for 7 days-or longer, depending on the pain intensity-was performed; patients were required to report their paracetamol consumption on a specific sheet between study day 8 to 180 days of follow-up. MRI studies of the thoracolumbar spine were performed at 0 (T0), 30 (T1) and 60 days of follow-up (T2) using a 1.5-T MRI system in all of the centres that took part in the study. For each VBME area examined via MRI, the vertebral body geometry (i.e. anterior wall height/posterior wall height and vertebral kyphosis) were assessed. RESULTS: A total of 66 patients (male: 9, 13.63%; mean age: 73.15 years old) with 69 VFFs were included in the present study and randomized as follows: 33 patients were included in the control group and the remaining 33 patients were randomized into the CCEF group. In the CCEF group, good compliance with CCEF therapy was observed (adherence = 94%), and no adverse effects were recorded. In the stimulated patients, faster VBME resolution and significantly less vertebral body collapse during follow-up were observed compared to the control patients. Moreover, in the active group, faster pain reduction and improvement in the ODI mean score were observed. Stimulated patients also reported a significantly lower paracetamol consumption rate from the third follow-up after treatment until the 6-month follow-up. In terms of sex-related differences, in the CCEF group, VBME showed a faster resolution in male patients compared with females. CONCLUSION: Biophysical stimulation with CCEF, as an adjunct to traditional conservative treatment, is a useful tool to hasten the VBME resolution process and prevent vertebral body deformation. These MRI findings also correlate with faster back pain resolution and quality of life improvement. From the third follow-up after treatment until the 6-month follow-up, stimulated patients reported a significantly lower paracetamol consumption than control patients, even though back pain and quality of life showed no significant differences between the two groups. LEVEL OF EVIDENCE: II. Trial Registration Register: ClinicalTrials.gov, number: NCT05803681.

Gender-Specific Differences in Human Vertebral Bone Marrow Clot.

Recently, our group described the application of vertebral bone marrow (vBMA) clot as a cell therapy strategy for spinal fusion. Its beneficial effects were confirmed in aging-associated processes, but the influence of gender is unknown. In this study, we compared the biological properties of vBMA clots and derived vertebral mesenchymal stem cells (MSCs) from female and male patients undergoing spinal fusion procedures and treated with vBMA clot. We analyzed the expression of growth factors (GFs) in vBMA clots and MSCs as well as morphology, viability, doubling time, markers expression, clonogenicity, differentiation ability, senescence factors, Klotho expression, and HOX and TALE gene profiles from female and male donors. Our findings indicate that vBMA clots and derived MSCs from males had higher expression of GFs and greater osteogenic and chondrogenic potential compared to female patients. Additionally, vBMA-clot-derived MSCs from female and male donors exhibited distinct levels of HOX and TALE gene expression. Specifically, HOXA1, HOXB8, HOXD9, HOXA11, and PBX1 genes were upregulated in MSCs derived from clotted vBMA from male donors. These results demonstrate that vBMA clots can be effectively used for spinal fusion procedures; however, gender-related differences should be taken into consideration when utilizing vBMA-clot-based studies to optimize the design and implementation of this cell therapy strategy in clinical trials.

An inter- and intra-rater agreement assessment of a novel classification of pyogenic spinal infections.

PURPOSE: Pola et al. described a clinical-radiological classification of pyogenic spinal infections (PSI) based on magnetic resonance imaging (MRI) features including vertebral destruction, soft tissue involvement, and epidural abscess, along with the neurological status. We performed an inter- and intra-observer agreement evaluation of this classification. METHODS: Complete MRI studies of 80 patients with PSI were selected and classified using the scheme described by Pola et al. by seven evaluators. After a four-week interval, all cases were presented to the same assessors in a random sequence for repeat assessment. We used the weighted kappa statistics (wκ) to establish the inter- and intra-observer agreement. RESULTS: The inter-observer agreement was substantial considering the main categories (wκ = 0.77; 0.71-0.82), but moderate considering the subtypes (wκ = 0.51; 0.45-0.58). The intra-observer agreement was substantial considering the main types (wκ = 0.65; 0.59-0.71), and moderate considering the subtypes (wκ = 0.58; 0.54-0.63). CONCLUSION: The agreement at the main type level indicates that this classification allows adequate communication and may be used in clinical practice; at the subtypes level, the agreement is only moderate.

Spinal surgery complications: an unsolved problem-Is the World Health Organization Safety Surgical Checklist an useful tool to reduce them?

PURPOSE: To investigate whether the World Health Organization Safety Surgical Checklist (SSC) is an effective tool to reduce complications in spinal surgery. METHODS: We retrospectively evaluated the clinical and radiological charts prospectively collected from patients who underwent a spinal surgery procedure from January 2010 to December 2012. The aim of this study was to compare 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's effectiveness. RESULTS: The sample size was 917 patients with an average of 30-month follow-up. The mean age was 52.88 years. The majority of procedures were performed for oncological diseases (54.4%) and degenerative diseases (39.8%). In total, 159 complications 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 in 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%). CONCLUSIONS: The 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 preoperative and postoperative phases in order to further reduce the incidence of complications. These slides can be retrieved under Electronic Supplementary Material.

Effect of strontium substituted ß-TCP associated to mesenchymal stem cells from bone marrow and adipose tissue on spinal fusion in healthy and ovariectomized rat.

Despite alternatives to autogenous bone graft for spinal fusion have been investigated, it has been shown that osteoconductive materials alone do not give a rate of fusion comparable with autogenous bone. This study analyzed a strontium substituted ß-tricalcium phosphate (Sr-ßTCP) associated with syngeneic, unexpanded, and undifferentiated mesenchymal stem cells from bone marrow (BMSC) or adipose tissue (ADSC) as a new tissue engineering approach for spinal fusion procedures. A posterolateral fusion was performed in 15 ovariectomized (OVX) and 15 sham-operated (SHAM) Inbred rats. Both SHAM and OVX animals were divided into three groups: Sr-ßTCP, Sr-ßTCP + BMCSs, and Sr-ßTCP + ADSCs. Animals were euthanized 8 weeks after surgery and the spines evaluated by manual palpation, micro-CT, and histology. For both SHAM and OVX animals, the fusion tissue in the Sr-ßTCP + BMSCs group was more solid. This effect was significantly higher in OVX animals by comparing the Sr-ßTCP + BMCSs group with Sr-ßTCP + ADSCs. Radiographical score, based on micro-CT 2D image, highlighted that the Sr-ßTCP + BMCSs group presented a similar fusion to Sr-ßTCP and higher than Sr-ßTCP + ADSCs in both SHAM and OVX animals. Micro-CT 3D parameters did not show significant differences among groups. Histological score showed significantly higher fusion in Sr-ßTCP + BMSCs group than Sr-ßTCP and Sr-ßTCP + ADSCs, for both SHAM and OVX animals. In conclusion, our results suggest that addition of BMSCs to a Sr-ßTCP improve bone formation and fusion, both in osteoporotic and nonosteoporotic animal, whereas spinal fusion is not enhanced in rats treated with Sr-ßTCP + ADSCs. Thus, for conducting cells therapy in spinal surgery BMSCs still seems to be a better choice compared with ADSCs.

Innovative Biomaterials for Bone Regrowth.

The regenerative medicine, a new discipline that merges biological sciences and the fundamental of engineering to develop biological substitutes, has greatly benefited from recent advances in the material engineering and the role of stem cells in tissue regeneration. Regenerative medicine strategies, involving the combination of biomaterials/scaffolds, cells, and bioactive agents, have been of great interest especially for the repair of damaged bone and bone regrowth. In the last few years, the life expectancy of our population has progressively increased. Aging has highlighted the need for intervention on human bone with biocompatible materials that show high performance for the regeneration of the bone, efficiently and in a short time. In this review, the different aspects of tissue engineering applied to bone engineering were taken into consideration. The first part of this review introduces the bone cellular biology/molecular genetics. Data on biomaterials, stem cells, and specific growth factors for the bone regrowth are reported in this review.

Substantial Overview on Mesenchymal Stem Cell Biological and Physical Properties as an Opportunity in Translational Medicine.

Mesenchymal stem cells (MSC) have piqued worldwide interest for their extensive potential to treat a large array of clinical indications, their unique and controversial immunogenic and immune modulatory properties allowing ample discussions and debates for their possible applications. Emerging data demonstrating that the interaction of biomaterials and physical cues with MSC can guide their differentiation into specific cell lineages also provide new interesting insights for further MSC manipulation in different clinical applications. Moreover, recent discoveries of some regulatory molecules and signaling pathways in MSC niche that may regulate cell fate to distinct lineage herald breakthroughs in regenerative medicine. Although the advancement and success in the MSC field had led to an enormous increase in the amount of ongoing clinical trials, we still lack defined clinical therapeutic protocols. This review will explore the exciting opportunities offered by human and animal MSC, describing relevant biological properties of these cells in the light of the novel emerging evidence mentioned above while addressing the limitations and challenges MSC are still facing.

Bone marrow aspirate clot: A technical complication or a smart approach for musculoskeletal tissue regeneration?

One of the methods employed to improve healing of damaged tissues is the use of cellular based therapies. A number of regenerative medicine based strategies, from in vitro expanded mesenchymal stem cells (MSCs) to "one-step" procedures using bone marrow (BM) in toto (BM aspirate; BMA) or BM concentrate (BMC), have been developed. Recently, orthopedic researchers focused their attention on the clinical therapeutic potential of BMC and BMA for musculoskeletal regeneration. BMA is reported as an excellent source of cells and growth factors. However, the quality of BM harvest and aspirate is extremely technique-dependent and, due to the presence of megakaryocytes and platelets, BMA is prone to clot. BMA clot formation is usually considered a complication hampering the procedures on both BMC preparation and MSC expansion. Therefore, different protocols have been developed to avoid and/or degrade clots. However, from a biological point of view there is a strong rationale for the use of BMA clot for tissue engineering strategies. This descriptive systematic literature review summarizes preclinical and clinical studies dealing the use of BMA clot for orthopedic procedures and provided some evidence supporting its use as a cell based therapy for cartilage and bone regeneration. Despite these results, there are still few preclinical and clinical studies that carefully evaluate the safety and efficacy of BMA clot in orthopedic procedures. Thus, implementing biological knowledge and both preclinical and clinical studies could help researchers and clinicians to understand if BMA clots can really be considered a possible therapeutic tool.

The Size of Simulated Lytic Metastases Affects the Strain Distribution on the Anterior Surface of the Vertebra.

Metastatic lesions of the vertebra are associated with risk of fracture, which can be disabling and life-threatening. In the literature, attempts are found to identify the parameters that reduce the strength of a metastatic vertebra leading to spine instability. However, a number of controversial issues remain. Our aim was to quantify how the strain distribution in the vertebral body is affected by the presence and by the size of a simulated metastatic defect. Five cadaveric thoracic spine segments were subjected to non-destructive presso-flexion while intact, and after simulation of metastases of increasing size. For the largest defect, the specimens were eventually tested to failure. The full-field strain distribution in the elastic range was measured with digital image correlation (DIC) on the anterior surface of the vertebral body. The mean strain in the vertebra remained similar to the intact when the defects were smaller than 30% of the vertebral volume. The mean strains became significantly larger than in the intact for larger defects. The map of strain and its statistical distribution indicated a rather uniform condition in the intact vertebra and with defects smaller than 30%. Conversely, the strain distribution became significantly different from the intact for defects larger than 30%. A strain peak appeared in the region of the simulated metastasis, where fracture initiated during the final destructive test. This is a first step in understanding how the features of metastasis influence the vertebral strain and for the construction of a mechanistic model to predicted fracture.

Biomimetic 3D-printed custom-made prosthesis for anterior column reconstruction in the thoracolumbar spine: a tailored option following en bloc resection for spinal tumors : Preliminary results on a case-series of 13 patients.

PURPOSE: Various techniques for anterior column reconstruction have been described after en bloc resection of spinal tumors. Limited evidence exists regarding one being superior to another. The purpose of this study is to evaluate 3D-printed vertebral bodies for spinal reconstruction after en bloc resection in the thoracolumbar spine. METHODS: Prospective observational study on custom-made 3D-printed titanium reconstruction of vertebral bodies after en bloc resection for spinal tumor was conducted between November 2015 and June 2017. 3D-printed vertebral bodies were monitored for mechanical complications such as (1) migration, (2) subsidence into the adjacent vertebral bodies, and/or (3) breakage. Complications and related details were recorded. RESULTS: Thirteen patients (7 females and 6 males) were enrolled, and reconstruction of the anterior column was performed using custom-made 3D-printed titanium prosthesis after en bloc resection for spinal tumor (8 primary bone tumors and 5 solitary metastases). Subsidence into the adjacent vertebral bodies occurred in all patients at both proximal and distal bone-implant interfaces; however, it was clinically irrelevant (asymptomatic, and no consequences on posterior instrumentation), in 11 out of 12 patients (92%). In 1 patient (#4), severity of the subsidence led to revision of the construct. At an average 10-month follow-up (range 2-16), 1 implant was removed due to local recurrence of the disease and 1 was revisioned due to progressive distal junctional kyphosis. CONCLUSION: Preliminary results from this series suggest that 3D printing can be effectively used to produce custom-made prosthesis for anterior column reconstruction. These slides can be retrieved under Electronic Supplementary Material.

Aneurysmal bone cyst of the spine treated by concentrated bone marrow: clinical cases and review of the literature.

PURPOSE: ABC is a benign lesion with unpredictable behavior. Its treatment is challenging, especially in poorly accessible surgical areas, such as spine and pelvis. Currently, the first-line treatment of ABC is repeated selective arterial embolization (SAE) until healing. Other options have been used with variable success rates. We propose an alternative treatment for spine aneurysmal bone cyst (sABC) based on the injection of concentrated autologous bone marrow. METHODS: We retrospectively report and analyze here two cases of patients, a 14-year-old girl and a 16-year-old boy, both affected by ABC in C2 vertebra which were impossible to treat by SAE. They were treated with single or repeated injection of concentrated autologous bone marrow into the lesion. Their follow-up period is 27 months for both patients. RESULTS: In the two cases reported here we observed a progressive ossification of the lesion, which was slow in one case, requiring three subsequent injections of concentrated bone marrow, and fast in the other case, beginning 1 month after the procedure. In both cases, the healing of the lesion was associated with symptom relief and the clinical status of the patients remains stable after 2 years. CONCLUSIONS: Although SAE can still be considered the first line in the treatment of ABC in the axial skeleton, new promising therapeutic procedures involving the use of mesenchymal stem cells are developing.

Significant association between human osteosarcoma and simian virus 40.

BACKGROUND: Simian virus 40 (SV40) has been considered to be an oncogenic viral agent in the development of osteosarcoma (OS), which to the authors' knowledge continues to be of unknown etiology. METHODS: In the current study, serum samples from patients with OS were investigated with an indirect enzyme-linked immunoadsorbent assay (ELISA) to test for the presence of immunoglobulin G antibodies, which react with SV40 antigens. In ELISA, SV40 antigens were represented by 2 synthetic polypeptides that mimic epitopes of the viral capsid proteins 1 to 3. Additional sera from patients with breast cancer and undifferentiated nasopharyngeal carcinoma as well as healthy subjects were the controls. RESULTS: Immunologic results suggested that antibodies that react with SV40 mimotopes were more prevalent (44%) in serum samples from patients with OS compared with healthy subjects (17%). The difference in prevalence between these cohorts was statistically significant (P<.001). It is interesting to note that in the patients with OS, significance indicated the difference between OS versus breast cancer (44% vs 15%; P<.001) and OS versus undifferentiated nasopharyngeal carcinoma (44% vs 25%; P<.05). CONCLUSIONS: The data from the current study indicate an association between OS and SV40. These data could be transferred to clinical applications for innovative therapies to address SV40-positive OS.

Mesenchymal stem cells derived from vertebrae (vMSCs) show best biological properties.

PURPOSE: Due to their properties and characteristics human mesenchymal stem cells (MSCs) appear to have great therapeutic potential. Many different populations of MSCs have been described and to understand whether they have equivalent biological properties is a critical issue for their therapeutic application. METHODS: We proposed to analyze the in vitro growth kinetics of MSCs derived from different body sites (iliac crest bone marrow, vertebrae bone marrow, colon mucosa, dental pulp). RESULTS: Mesenchymal stem cells derived from vertebrae can be maintained in culture for a greater number of steps and they also generate mature cells of all mesenchymal lineages with greater efficiency, when induced into osteogenic, adipogenic and chondrogenic differentiation. CONCLUSIONS: The ability of vertebrae-derived MSCs in terms of expansion and differentiation is very interesting at the light of a clinical application for bone fusion in spine surgery.

Do benefits overcome the risks related to surgery for adult scoliosis? A detailed analysis of a consecutive case series.

PURPOSE: The surgical approach to adult spine deformities is complex and presents a high incidence of complications. METHODS: We report here a prospective consecutive case series analysis of 20 patients submitted to posterior correction and instrumented fusion for adult degenerative scoliosis. Clinical outcomes were assessed by self-reported measures. Pre-operative and post-operative complications were analysed during a mean 30-month follow-up period. RESULTS: Eleven patients (55 %) presented pre-operative or post-operative complications. Fifteen different complications occurred, six in the early pre-operative period and nine during follow-up period: ten of these complications occurred in patients who underwent a previous surgery for spine disease. CONCLUSIONS: The clinical improvement at the final follow-up resulted as statistically significant only for the group of patients exposed to posterior fusion without interbody fusion. The observations reported here have to be considered for a shared decision-making in the management of adult scoliosis.

Correlation Between Sagittal Balance and Mechanical Distal Junctional Failure in Degenerative Pathology of the Spine: A Retrospective Analysis.

STUDY DESIGN: Retrospective cohort study. OBJECTIVES: This study aimed to investigate the failure of the caudal end of lumbar posterior fixation in terms of pre-operative and post-operative spinopelvic parameters, correction performed, demographic and clinical data. METHODS: The lumbar, thoraco-lumbar and lumbo-sacral posterior fixations performed with pedicle screws and rods in 2017-2019 were retrospectively analyzed. As 81% failures occurred within 4 years, an observational period of 4 years was chosen. The revision surgeries due to the failure in the caudal end were collected in the junctional group. Fixations which have not failed were gathered in the control group. The main spinopelvic parameters were measured for each patient on standing lateral radiographs with the software Surgimap. Demographic and clinical data were extracted for both groups. RESULTS: Among the 457 patients who met the inclusion criteria, the junctional group included 101 patients, who required a revision surgery. The control group collected 356 primary fixations. The two most common causes of revision surgeries were screws pullout (57 cases) and rod breakage (53 cases). SVA, PT, LL, PI-LL and TPA differed significantly between the two groups (P = .021 for LL, P < .0001 for all the others). The interaction between the two groups and the pre-operative and post-operative conditions was significant for PT, SS, LL, TK, PI-LL and TPA (P < .005). Sex and BMI did not affect the failure onset. CONCLUSIONS: Mechanical failure is more likely to occur in patients older than 40 years with a thoraco-lumbar fixation where PT, PI-LL and TPA were not properly restored.

Safety and efficacy of autologous bone marrow clot as a multifunctional bioscaffold for instrumental posterior lumbar fusion: a 1-year follow-up pilot study.

Background: Bone marrow aspirate (BMA), when combined with graft substitutes, has long been introduced as a promising alternative to iliac crest bone graft in spinal fusion. However, the use of BMA is limited by the absence of a standardized procedure, a structural texture, and the potential for diffusion away from the implant site. Recently, the potential use of a new formulation of BMA, named BMA clot, has been preclinically described. In this report, we present the results of a prospective pilot clinical study aimed at evaluating the safety and efficacy of autologous vertebral BMA (vBMA) clot as a three-dimensional and multifunctional bioscaffold in instrumented posterior lumbar fusion. Methods: Ten consecutive patients with an indication of multilevel (≤5) posterior spinal fusion due to lumbar spine degenerative diseases were included in the study and treated with vBMA. Clinical outcomes were assessed using the Visual Analog Scale (VAS), Oswestry Disability Index (ODI), and EuroQoL-5L (EQ-5L) preoperatively and at 3 months and 12 months after spinal fusion. Bone fusion quality was evaluated at the 12-month follow-up using the Brantigan classification on radiography (XR) imaging. Bone density was measured on computed tomography (CT) scans at 6 and 12 months of follow-up visits at the intervertebral arches and intervertebral joint areas and expressed in Hounsfield unit (HU). Results: The results indicate a successful posterolateral fusion rate of approximately 100% (considering levels with C, D, and E grades according to the Brantigan classification) at the 12-month follow-up, along with an increase in bone density from 6 to 12 months of follow-up. An improvement in the quality of life and health status following surgery, as assessed by clinical scores (ODI, VAS, and EQ-5L), was also observed as early as 3 months postsurgery. No adverse events related to the vBMA clot were reported. Conclusion: This prospective pilot study demonstrates the effectiveness and safety profile of vBMA clot as an advanced bioscaffold capable of achieving posterior lumbar fusion in the treatment of degenerative spine diseases. This lays the groundwork for a larger randomized clinical study.

Carbon Fiber-Reinforced PolyEtherEtherKetone (CFR-PEEK) Instrumentation in Degenerative Disease of Lumbar Spine: A Pilot Study.

CFR-PEEK is gaining popularity in spinal oncological applications due to its reduction of imaging artifacts and radiation scattering compared with titanium, which allows for better oncological follow-up and efficacy of radiotherapy. We evaluated the use of these materials for the treatment of lumbar degenerative diseases (DDs) and considered the biomechanical potential of the carbon fiber in relation to its modulus of elasticity being similar to that of bone. Twenty-eight patients with DDs were treated using CRF-PEEK instrumentation. The clinical and radiographic outcomes were collected at a 12-month FU. Spinal fusion was evaluated in the CT scans using Brantigan scores, while the clinical outcomes were evaluated using VAS, SF-12, and EQ-5D scores. Out of the patients evaluated at the 12-month FU, 89% showed complete or almost certain fusion (Brantigan score D and E) and presented a significant improvement in all clinical parameters; the patients also presented VAS scores ranging from 6.81 ± 2.01 to 0.85 ± 1.32, EQ-5D scores ranging from 53.4 ± 19.3 to 85.0 ± 13.7, SF-12 physical component scores (PCSs) ranging from 29.35 ± 7.04 to 51.36 ± 9.75, and SF-12 mental component scores (MCSs) ranging from 39.89 ± 11.70 to 53.24 ± 9.24. No mechanical complications related to the implant were detected, and the patients reported a better tolerance of the instrumentation compared with titanium. No other series of patients affected by DD that was stabilized using carbon fiber implants have been reported in the literature. The results of this pilot study indicate the efficacy and safety of these implants and support their use also for spinal degenerative diseases.

Indications and Limits of Surgery for Spinal Metastases Derived from Lung Cancer: A Single-Center Experience.

Lung cancer is the second most frequently diagnosed cancer in the world, and surgery is an integral part of the treatment for spinal metastases. The aims of this retrospective study were to assess the overall survival of surgically treated patients affected by lung cancer spinal metastases and identify any factors related to a better survival rate. We recruited 56 consecutive patients (34 male and 22 female) surgically treated for metastatic lung cancer in the spine from 2009 to 2019. Surgical indications were based on a previously published and validated flow chart following a multidisciplinary evaluation. We assessed the localization of vertebral metastases, the presence of other bone or visceral metastases, neurological status according to the Frankel score, ambulatory autonomy, and general status, measured with the Karnofsky performance scale. The expected prognosis was retrospectively assessed according to the revised Tokuhashi score. The median survival was 8.1 months, with over a third of patients surviving more than 1 year. We observed a global improvement in all clinical parameters after surgical treatment. The Tokuhashi predictive score did not correlate with survival after surgery. The results of this study suggest that the surgical treatment of symptomatic spinal metastases from lung cancer can improve quality of life, even in patients with a shorter life expectancy, by controlling pain and improving autonomy.

Ceramic bone graft substitute (Mg-HA) in spinal fusion: A prospective pilot study.

Background: Iliac crest bone graft (ICBG) is considered the gold standard for spine surgical procedures to achieve a successful fusion due to its known osteoinductive and osteoconductive properties. However, complications related to harvesting procedure and donor site morbidity have been largely reported in the literature, favoring the development of a wide range of alternative products to be used as bone graft extenders or substitutes for spine fusion. Among all, ceramic-based biomaterials have been widely studied and employed in the last years as bone graft substitutes. Methods: We report here the results of a prospective pilot study aimed to evaluating the grade of ossification obtained by the use of an Mg-doped hydroxyapatite (HA) product to achieve postero-lateral fusion in degenerative spine diseases. Results: Results show a successful degree of fusion of about 62% at the 12-month follow-up and an improvement of quality of life and health status following surgery, as evaluated by clinical scores (ODI, VAS, and EQ-5L). No adverse events related to the material were reported. Conclusion: The present pilot study shows the effectiveness and the safety profile of an Mg-doped HA bone graft substitute used to achieve postero-lateral fusion in the treatment of degenerative spine diseases, laying down the basis for further larger clinical investigations.