Is Advanced Age a Factor That Influences the Clinical Outcome of Single- or Double-Level MIS-TLIF? A Single-Center Study with a Minimum Two-Year Follow-Up on 103 Consecutive Cases.

As life expectancy rises, more elderly people undergo spinal fusion surgery to treat lumbar degenerative diseases. The MIS-TLIF technique, which minimizes soft tissue manipulation, is a promising fusion technique for frailer patients. The aim of this study was to investigate if older age is a significant factor in the clinical outcome of single- or double-level MIS-TLIF. A cross-sectional study was conducted on 103 consecutive patients. Data were compared between younger (<65 y.o.) and older (≥65 y.o.) patients. We observed no significant differences between baseline characteristics of the two groups apart from the frequency of disk space treated, with a relative predominance of L3-L4 space treated in the elderly (10% vs. 28%, p = 0.01) and L5-S1 space in younger patients (36% vs. 5%, p = 0.006). There was no significant difference in complication rate, surgical satisfaction, EQ 5D-5L, or Oswestry Disability Index (ODI) global or specific scores, with the exception of the EQ 5D-5L "mobility" score, where older patients fared worse (1.8 ± 1.1 vs. 2.3 ± 1.4; p = 0.05). The minimal invasiveness of the surgical technique, age-related specific outcome expectations, and biomechanical issues are all potential factors influencing the lack of age group differences in outcome scores.

Towards a common language in neurosurgical outcome evaluation: the NEON (NEurosurgical Outcome Network) proposal.

BACKGROUND: The aim of this study was to achieve a consensus on the minimum set of outcome measures and predictors to be used in the neurosurgical practice and on the timing of outcome assessment. METHODS: A consensus building approach was employed. All neurosurgical departments in Lombardy (Italy) were invited to participate by the Carlo Besta Neurologic Institute IRCCS Foundation. Three workshops were organized during which a multidisciplinary group called Neurosurgical Outcome Network (NEON) was created and the methodology to select outcome measures, predictors, and timing of outcome assessment was established. Eight working groups were created for the different neurosurgical diseases (neuro-oncological, skull base, vascular, traumatic, spinal, peripheral nervous system, malformation, functional) and 8 workshops were organized to identify the outcome measures and predictors specific for each of the neurosurgical diseases based on the experts' clinical practice and the existing literature. RESULTS: A total of 20 neurosurgical departments participated in this study. Specific outcome measures, predictors and the timing of outcome assessment were identified for each of the 8 neurosurgical diseases. Moreover, a list of variables common to all pathologies were identified by the NEON group as further data to be collected. CONCLUSIONS: A consensus on the minimum set of outcome measures and predictors and the timing of outcome assessments for 8 neurosurgical diseases was achieved by a group of neurosurgeons of the Lombardy region, called NEON. These sets could be used in future studies for a more homogeneous data collection and as a starting point to reach further agreement also at national and international level.

Is Gender a Factor Affecting Long-Term Heterotopic Ossification Incidence After Single-Level Cervical Disc Arthroplasty?

BACKGROUND: Cervical disc diseases have been treated by cervical disc arthroplasty (CDA). Nevertheless, some patients will experience a mobility failure in their cervical prostheses over time because of heterotopic ossification. The aim of this study was to investigate the role of gender in long-term outcomes after CDA. METHODS: A retrospective, single-center study of patients who underwent single-level CDA with a BRYAN Cervical Disc prosthesis was performed, including a narrative review about gender differences in both structural and biomechanical features of the cervical spine. RESULTS: Study patients (14 men, 30 women) had an average follow-up of 9.8 ± 3.2 years. Significant differences emerged between genders for specific items in Neck Disability Index preoperative evaluation, with women reporting worse pain scores (P = 0.05). After stratification by age, we found a higher preoperative overall Neck Disability Index score for female patients <36 years of age (P = 0.03). In an intergender, body mass index-specific comparison, we also found a significant difference in Neck Disability Index preoperative score with normal-weight male patients faring worse than overweight male patients (P = 0.05). At a radiological level, we found a tendency toward a higher heterotopic ossification incidence in male patients (62% in men, 17% in women, P = 0.06). The female cervical spine has distinctive features, including bone structure, muscular action, soft tissue response, and genetic and epigenetic response to osteoarthritis. CONCLUSIONS: The incidence of mobility failure in our series of single-level CDA was lower in female patients. Several gender-specific factors both in static and in dynamic features may play a significant role in spinal pathology and CDA long-term radiological outcome.

Anxiety in neurosurgical patients undergoing nonurgent surgery during the COVID-19 pandemic.

OBJECTIVE: The COVID-19 pandemic has forced many countries into lockdown and has led to the postponement of nonurgent neurosurgical procedures. Although stress has been investigated during this pandemic, there are no reports on anxiety in neurosurgical patients undergoing nonurgent surgical procedures. METHODS: Neurosurgical patients admitted to hospitals in eastern Lombardy for nonurgent surgery after the lockdown prospectively completed a pre- and postoperative structured questionnaire. Recorded data included demographics, pathology, time on surgical waiting list, anxiety related to COVID-19, primary pathology and surgery, safety perception during hospital admission before and after surgery, and surgical outcomes. Anxiety was measured with the State-Trait Anxiety Inventory. Descriptive statistics were computed on the different variables and data were stratified according to pathology (oncological vs nononcological). Three different models were used to investigate which variables had the greatest impact on anxiety, oncological patients, and safety perception, respectively. Because the variables (Xs) were of a different nature (qualitative and quantitative), mostly asymmetrical, and related to outcome (Y) by nonlinear relationships, a machine learning approach composed of three steps (1, random forest growing; 2, relative variable importance measure; and 3, partial dependence plots) was chosen. RESULTS: One hundred twenty-three patients from 10 different hospitals were included in the study. None of the patients developed COVID-19 after surgery. State and trait anxiety were reported by 30.3% and 18.9% of patients, respectively. Higher values of state anxiety were documented in oncological compared to nononcological patients (46.7% vs 25%; p = 0.055). Anxiety was strongly associated with worry about primary pathology, surgery, disease worsening, and with stress during waiting time, as expected. Worry about positivity to SARS-CoV-2, however, was the strongest factor associated with anxiety, even though none of the patients were infected. Neuro-oncological disease was associated with state anxiety and with worry about surgery and COVID-19. Increased bed distance and availability of hand sanitizer were associated with a feeling of safety. CONCLUSIONS: These data underline the importance of psychological support, especially for neuro-oncological patients, during a pandemic.

Positioning issues of spinal surgery during pregnancy.

BACKGROUND: Albeit rarely, different spinal pathologies may require surgical treatment during pregnancy. The management of such cases poses a series of challenges, starting with adequate body positioning. OBJECTIVE: To illustrate limits and indications of the different surgical positioning strategies for pregnant women undergoing spine surgery. METHODS: We performed a systematic review of literature about the described surgical positioning strategies used for spinal surgery during pregnancy, discussing advantages, indications, and limits. We also describe of a novel three-quarters prone positioning for dorsal pathology. RESULTS: The surgical strategy may vary according to several factors, such as the location and the nature of the underlying pathology, the stage of the pregnancy, and the clinical condition of mother and fetus. During the second trimester, the habitus begins to raise issues about both the abdominal and the aortocaval compressions. The third trimester implies neonatal and ethical challenges: both fetal monitoring and the possibility of urgently proceeding to delivery should be guaranteed. The prone position is feasible during the second trimester provided an adequate frame is supplied. The lateral or three-quarters prone positioning may offer the safest option in the last stages of pregnancy, whereas both supine and sitting positionings are anecdotal. CONCLUSIONS: Gestational age, surgical comfort and maternofetal safety should be balanced by a multidisciplinary team to tailor an adequate positioning plan for each individual case. The early third trimester is the more limiting period because of the womb hindrance favoring lateral or three-quarters positionings.

Epidemiologic and Economic Burden Attributable to First Spinal Fusion Surgery: Analysis From an Italian Administrative Database.

STUDY DESIGN: Retrospective large population based-study. OBJECTIVE: Assessment of the epidemiologic trends and economic burden of first spinal fusions. SUMMARY OF BACKGROUND DATA: No adequate data are available regarding the epidemiology of spinal fusion surgery and its economic impact in Europe. METHODS: The study population was identified through a data warehouse (DENALI), which matches clinical and economic data of different Healthcare Administrative databases of the Italian Lombardy Region. The study population consisted of all subjects, resident in Lombardy, who, during the period January 2001 to December 2010, underwent spinal fusion surgery (ICD-9-CM codes: 81.04, 81.05, 81.06, 81.07, and 81.08). The first procedure was used as the index event. We estimated the incidence of first spinal fusion surgery, the population and surgery characteristics and the healthcare costs from the National Health Service's perspective. The analysis was performed for the entire population and divided into the main groups of diagnosis. RESULTS: The analysis identified 17,772 [mean age (SD): 54.6 (14.5) years, 55.3% females] spinal fusion surgeries. Almost 67% of the patients suffered from a lumbar degenerative disease. The incidence rate of interventions increased from 11.5 to 18.5 per 100,000 person-year between 2001 and 2006, and was above 20.0 per 100,000 person-year in the last 4 years. The patients' mean age increased during the observational time period from 48.1 to 55.9 years; whereas the median hospital length of stay reported for the index event decreased. The average cost of the spinal fusion surgery increased during the observational period, from &OV0556; 4726 up to &OV0556; 9388. CONCLUSION: The study showed an increasing incidence of spinal fusion surgery and costs from 2001 to 2010. These results can be used to better understand the epidemiological and economic burden of these interventions, and help to optimize the resources available considering the different clinical approaches accessible today. LEVEL OF EVIDENCE: 4.

MASTERS-D Study: A Prospective, Multicenter, Pragmatic, Observational, Data-Monitored Trial of Minimally Invasive Fusion to Treat Degenerative Lumbar Disorders, One-Year Follow-Up.

UNLABELLED: The objective of the study is to assess effectiveness and safety of minimally invasive lumbar interbody fusion (MILIF) for degenerative lumbar disorders (DLD) in daily surgical practice and follow up with patients for one year after surgery. A prospective, multicenter, pragmatic, monitored, international outcome study in patients with DLD causing back/leg pain was conducted (19 centers). Two hundred fifty-two patients received standard of care available in the centers. Patients were included if they were aged >18 years, required one- or two-level lumbar fusion for DLD, and met the criteria for approved device indications. Primary endpoints: time to first ambulation (TFA) and time to surgery recovery (TSR). Secondary endpoints: patient-reported outcomes (PROs)--back and leg pain (visual analog scale), disability (Oswestry Disability Index (ODI)), health status (EQ-5D), fusion rates, reoperation rates, change in pain medication, rehabilitation, return to work, patient satisfaction, and adverse events (AEs). Experienced surgeons (≥30 surgeries pre-study) treated patients with DLD by one- or two-level MILIF and patients were evaluated for one year (NCT01143324). At one year, 92% (233/252) of patients remained in the study. PRIMARY OUTCOMES: TFA, 1.3 ±0.5 days and TSR, 3.2 ±2.0 days. SECONDARY OUTCOMES: Most patients (83.3%) received one level MILIF; one (two-level) MILIF mean surgery duration, 128 (182) min; fluoroscopy time, 115 (154) sec; blood loss, 164 (233) mL; at one year statistically significant (P<.0001) and clinically meaningful changes from baseline were reported in all PROs--reduced back pain (2.9 ±2.5 vs. 6.2 ±2.3 at intake), reduced leg pain (2.2 ±2.6 vs. 5.9 ±2.8), and ODI (22.4% ± 18.6 vs. 45.3% ± 15.3), as well as health-related quality of life (EQ-5D index: 0.71 ±0.28 vs. 0.34 ±0.32). More of the professional workers were working at one year than those prior to surgery (70.3% vs. 55.2%). Three AEs and one serious AE were considered procedure-related; there were no deep site infections or deaths. This is the first study evaluating MILIF for treatment of DLD in daily clinical practice. Clinically significant improvements were observed in all endpoints. Short-term post-surgery improvements (four weeks) were maintained through one year with minimal complications. Our results suggest that MILIF has good-to-excellent outcomes for the treatment of DLD in a broad patient population under different clinical conditions and healthcare delivery systems.

A Cost-Effectiveness Analysis of Minimally Invasive versus Open Surgery Techniques for Lumbar Spinal Fusion in Italy and the United Kingdom.

OBJECTIVE: Evaluate the cost-effectiveness of minimally invasive surgery (MIS) compared with open surgery (OS) techniques for one- or two-level lumbar spinal fusion in the treatment of degenerative lumbar spinal conditions in the United Kingdom and Italy. METHODS: A health economic model was developed on the basis of results from a systematic literature review and meta-analysis to determine the cost-effectiveness of MIS compared with OS for lumbar spinal fusion. The analysis was conducted from a health care payer perspective. Parameters included in the model were surgery, blood loss, duration of hospitalization, postoperative complications, and health-related quality of life (HRQOL). Cost-effectiveness was determined by the incremental cost per quality-adjusted life-year gained. RESULTS: MIS was the dominant strategy compared with OS (i.e., yielding both cost savings and improved HRQOL). Cost savings were driven mainly by shorter length of hospital stay, reduced blood loss, and fewer complications such as surgical site infection. The total cost saving per procedure was €973 for Italy and €1666 for the United Kingdom, with an improvement of 0.04 quality-adjusted life-year over 2 years in HRQOL. One-way sensitivity analyses and predefined scenario(s) analyses confirmed the robustness of the model. CONCLUSIONS: MIS is a less expensive and a more effective treatment compared with OS for spinal lumbar fusion in both Italy and the United Kingdom. Lower downstream costs and increased HRQOL in the MIS group compensate for potential higher upfront costs of MIS implants and surgery equipment.

Surgical data and early postoperative outcomes after minimally invasive lumbar interbody fusion: results of a prospective, multicenter, observational data-monitored study.

UNLABELLED: Minimally invasive lumbar interbody fusion (MILIF) offers potential for reduced operative morbidity and earlier recovery compared with open procedures for patients with degenerative lumbar disorders (DLD). Firm conclusions about advantages of MILIF over open procedures cannot be made because of limited number of large studies of MILIF in a real-world setting. Clinical effectiveness of MILIF in a large, unselected real-world patient population was assessed in this Prospective, monitored, international, multicenter, observational study. OBJECTIVE: To observe and document short-term recovery after minimally invasive interbody fusion for DLD. MATERIALS AND METHODS: In a predefined 4-week analysis from this study, experienced surgeons (≥ 30 MILIF surgeries pre-study) treated patients with DLD by one- or two-level MILIF. The primary study objective was to document patients' short-term post-interventional recovery (primary objective) including back/leg pain (visual analog scale [VAS]), disability (Oswestry Disability Index [ODI]), health status (EQ-5D) and Patient satisfaction. RESULTS: At 4 weeks, 249 of 252 patients were remaining in the study; the majority received one-level MILIF (83%) and TLIF was the preferred approach (94.8%). For one-level (and two-level) procedures, surgery duration was 128 (182) min, fluoroscopy time 115 (154) sec, and blood-loss 164 (233) mL. Time to first ambulation was 1.3 days and time to study-defined surgery recovery was 3.2 days. Patients reported significantly (P < 0.0001) reduced back pain (VAS: 2.9 vs 6.2), leg pain (VAS: 2.5 vs 5.9), and disability (ODI: 34.5% vs 45.5%), and a significantly (P < 0.0001) improved health status (EQ-5D index: 0.61 vs 0.34; EQ VAS: 65.4 vs 52.9) 4 weeks postoperatively. One adverse event was classified as related to the minimally invasive surgical approach. No deep site infections or deaths were reported. CONCLUSIONS: For experienced surgeons, MILIF for DLD demonstrated early benefits (short time to first ambulation, early recovery, high patient satisfaction and improved patient-reported outcomes) and low major perioperative morbidity at 4 weeks postoperatively.

Stand-alone cage for posterior lumbar interbody fusion in the treatment of high-degree degenerative disc disease: design of a new device for an "old" technique. A prospective study on a series of 116 patients.

Chronic lumbar pain due to degenerative disc disease affects a large number of people, including those of fully active age. The usual self-repair system observed in nature is a spontaneous attempt at arthrodesis, which in most cases leads to pseudoarthrosis. In recent years, many possible surgical fusion techniques have been introduced; PLIF is one of these. Because of the growing interest in minimally invasive surgery and the unsatisfactory results reported in the literature (mainly due to the high incidence of morbidity and complications), a new titanium lumbar interbody cage (I-FLY) has been developed to achieve solid bone fusion by means of a stand-alone posterior device. The head of the cage is blunt and tapered so that it can be used as a blunt spreader, and the core is small, which facilitates self-positioning. From 2003 to 2007, 119 patients were treated for chronic lumbar discopathy (Modic grade III and Pfirrmann grade V) with I-FLY cages used as stand-alone devices. All patients were clinically evaluated preoperatively and after 1 and 2 years by means of a neurological examination, visual analogue score (VAS) and Prolo Economic and Functional Scale. Radiological results were evaluated by polyaxial computed tomography (CT) scan and flexion-extension radiography. Fusion was defined as the absence of segmental instability on flexion-extension radiography and Bridwell grade I or II on CT scan. Patients were considered clinical "responders" if VAS evaluation showed any improvement over baseline values and a Prolo value >7 was recorded. At the last follow-up examination, clinical success was deemed to have been achieved in 90.5% of patients; the rate of bone fusion was 99.1%, as evaluated by flexion-extension radiography, and 92.2%, as evaluated by CT scan. Morbidity (nerve root injury, dural lesions) and complications (subsidence and pseudoarthrosis) were minimal. PLIF by means of the stand-alone I-FLY cage can be regarded as a possible surgical treatment for chronic low-back pain due to high-degree DDD. This technique is not demanding and can be considered safe and effective, as shown by the excellent clinical and radiological success rates.

Treatment of discogenic low back pain with Intradiscal Electrothermal Therapy (IDET): 24 months follow-up in 50 consecutive patients.

BACKGROUND: Degeneration of the intervertebral disc can be the source of severe low back pain. Intradiscal electrothermal therapy (IDET) is a minimally invasive treatment option for patients with symptomatic internal disc disruption nonresponsive to conservative medical care. METHODS: Using MRI and discographic findings, 50 patients with lumbar discogenic pain were identified, underwent IDET treatment and were followed for 24 months. Outcomes included assessments of back pain severity by an 11-point numeric scale and back function by the Oswestry disability index (ODI). FINDINGS: There was an average 68 and 66% improvement in pain and ODI, respectively, between pre-treatment and 24 months (p < 0.0001 for both comparisons). The global clinical success rate was 78% (39 of 50). Clinical success was associated with discographic concordance (p < 0.0001), HIZ (p = 0.003), Pfirrmann grade (p = 0.0002), and percent annulus coverage (p < 0.0001). CONCLUSIONS: The findings of this study suggest that durable clinical improvements can be realized after IDET in highly selected patients with mild disc degeneration, confirmatory imaging evidence of annular disruption and concordant pain provocation by low pressure discography.

Lumbar total disc replacement: a numerical study.

AIM: The aim of this study was to evaluate the biomechanical effects of the Maverick(R) disc prosthesis at the implanted and adjacent level by the finite element (FE) method. MATERIALS AND METHODS: A 3D FE model of the L3-L5 segment was built. To simulate the different physiological movements (flexion, extension, lateral bending, axial rotation) pure moments of 10 Nm were applied. To evaluate the effect of the prosthesis, a 3D model of the device was built and inserted in the L3-L5 model. The ROMs obtained with the intact model were imposed as maximal rotations to the instrumented model, therefore implementing the Panjabi hybrid protocol. RESULTS: Increased ROMs at the implanted level and reduced ROMs at the adjacent level were predicted. A similar moment-rotation behavior was calculated after simulation of prosthesis insertion. No significant effect was predicted in terms of von Mises stress at the adjacent level after implantation of the prosthesis. CONCLUSIONS: Within the limitations of the models, the numerical results of this study predicted a preserved kinematics and stress at the adjacent segment, after insertion of the prosthesis.

Intradiscal electrothermal therapy for symptomatic internal disc disruption: 24-month results and predictors of clinical success.

OBJECT: Degeneration of the intervertebral disc can be the source of severe low-back pain. Intradiscal electrothermal therapy (IDET) is a minimally invasive treatment option for patients with symptomatic internal disc disruption unresponsive to conservative medical care. This study was undertaken in the neurosurgical setting to evaluate 24-month pain and functional outcomes and predictors of clinical success in patients with discogenic back pain treated with IDET. METHODS: Using MR imaging and discography findings, 50 patients with lumbar discogenic pain were identified, underwent IDET treatment, and were followed up for 24 months. Outcomes included assessments of back pain severity based on an 11-point numeric scale and back function based on the Oswestry Disability Index. The Prolo scale was applied to determine economic and functional status at 24 months. RESULTS: There was an average 68 and 66% improvement in back pain and function, respectively, between pretreatment and 24 months after treatment (p < 0.0001 for both comparisons). A maximum score of 5 on the Prolo scale for economic and functional status was achieved in 63 and 22% of patients, respectively. The global clinical success rate was 78% (39 of 50 patients) based on no reoperations at the affected level due to persistent symptoms, with a >or= 2-point improvement in pain severity and a >or= 15-point improvement in back function. Predictors of 24-month clinical success included discographic concordance (p < 0.0001), a high-intensity zone on MR imaging (p = 0.0003), low Pfirrmann grade (p = 0.0002), and more extensive anulus coverage (p < 0.0001). There were no procedure-related adverse events. CONCLUSIONS: The findings of this study suggest that durable clinical improvements can be realized after IDET in highly select surgical candidates with mild disc degeneration, confirmatory imaging evidence of anular disruption, and highly concordant pain provocation on low-pressure discography.

Early results and review of the literature of a novel hybrid surgical technique combining cervical arthrodesis and disc arthroplasty for treating multilevel degenerative disc disease: opposite or complementary techniques?

We report the clinical and radiological results on the safety and efficacy of an unusual surgical strategy coupling anterior cervical discectomy and fusion and total disc replacement in a single-stage procedure, in patients with symptomatic, multilevel cervical degenerative disc disease (DDD). The proposed hybrid, single-stage, fusion-nonfusion technique aims either at restoring or maintaining motion where appropriate or favouring bony fusion when indicated by degenerative changes. Twenty-four patients (mean age 46.7 years) with symptomatic, multilevel DDD, either soft disc hernia or different stage spondylosis per single level, with predominant anterior myeloradicular compression and absence of severe alterations of cervical spine sagittal alignment, have been operated using such hybrid technique. Fifteen patients underwent a two-level surgery, seven patients received a three-level surgery and two a four-level procedure, for a total of 59 implanted devices (27 disc prostheses and 32 cages). Follow-up ranged between 12 and 40 months (mean 23.8 months). In all but one patient clinical follow-up (neurological examination, Nurick scale, NDI, SF-36) demonstrated significant improvement; radiological evaluation showed functioning disc prostheses (total range of motion 3-15 degrees ) and fusion through cages. None of the patients needed revision surgery for persisting or recurring symptoms, procedure-related complications or devices dislocations. To the authors' best knowledge, this is the first study with the longest available follow-up describing a different concept in the management of cervical multilevel DDD. Although larger series with longer follow-up are needed, in selected cases of symptomatic multilevel DDD, the proposed surgical strategy appears to be a safe and reliable application of combined arthroplasty and arthrodesis during a single surgical procedure.

Anterior cervical fusion: a biomechanical comparison of 4 techniques. Laboratory investigation.

OBJECT: Cervical instrumented fusion is currently performed using several fixation methods. In the present paper, the authors compare the following 4 implantation methods: a stand-alone cage, a cage supplemented by an anterior locking plate, a cage supplemented by an anterior dynamic plate, and a dynamic combined plate-cage device. METHODS Four finite element models of the C4-7 segments were built, each including a different instrumented fixation type at the C5-6 level. A compressive preload of 100 N combined with a pure moment of 2.5 Nm in flexion, extension, right lateral bending, and right axial rotation was applied to the 4 models. The segmental principal ranges of motion and the load shared by the interbody cage were obtained for each simulation. RESULTS: The stand-alone cage showed the lowest stabilization capability among the 4 configurations investigated, but it was still significant. The cage supplemented by the locking plate was very stiff in all directions. The 2 dynamic plate configurations reduced flexibility in all directions compared with the intact case, but they left significant mobility in the implanted segment. These configurations were able to share a significant part of the load (up to 40% for the combined plate-cage) through the posterior cage. The highest risk of subsidence was obtained with the model of the stand-alone cage. CONCLUSIONS: Noticeable differences in the results were detected for the 4 configurations. The actual clinical relevance of these differences, currently considered not of critical importance, should be investigated by randomized clinical trials.