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Journal: Journal of neurosurgery. Spine

31

OBJECTIVE Motorcycle helmets have been shown to decrease the incidence and severity of traumatic brain injury due to motorcycle crashes. Despite this proven efficacy, some previous reports and speculation suggest that helmet use is associated with a higher likelihood of cervical spine injury (CSI). In this study, the authors examine 1061 cases of motorcycle crash victims who were treated during a 5-year period at a Level 1 trauma center to investigate the association of helmet use with the incidence and severity of CSI. The authors hypothesized that wearing a motorcycle helmet during a motorcycle crash is not associated with an increased risk of CSI and may provide some protective advantage to the wearer. METHODS The authors performed a retrospective review of all cases in which the patient had been involved in a motorcycle crash and was evaluated at a single Level 1 trauma center in Wisconsin between January 1, 2010, and January 1, 2015. Biometric, clinical, and imaging data were obtained from a trauma registry database. The patients were then divided into 2 distinct groups based on whether or not they were wearing helmets at the time of the accident. Baseline and functional characteristics were compared between the 2 groups. The Student t-test was used for continuous variables, and Pearson’s chi-square analysis was used for categorical variables. RESULTS In total, 1061 patient charts were examined containing data on 738 unhelmeted (69.6%) and 323 helmeted (30.4%) motorcycle riders. On average, helmeted riders had a much lower Injury Severity Score (p < 0.001). Cervical spine injury occurred in 114 unhelmeted riders (15.4%) compared with only 24 helmeted riders (7.4%) (p < 0.001), with an adjusted odds ratio of 2.3 (95% CI 1.44-3.61, p = 0.0005). In the unhelmeted group, 10.8% of patients were found to have a cervical spine fracture compared with only 4.6% of patients in the helmeted group (p = 0.001). Additionally, ligamentous injury occurred more frequently in unhelmeted riders (1.9% vs 0.3%, p = 0.04). No difference was found in the occurrence of cervical strain, cord contusion, or nerve root injury (all p > 0.05). CONCLUSIONS The results of this study demonstrate a statistically significant lower likelihood of suffering a CSI among helmeted motorcyclists. Unhelmeted riders sustained a statistically significant higher number of vertebral fractures and ligamentous injuries. The study findings reported here confirm the authors' hypothesis that helmet use does not increase the risk of developing a cervical spine fracture and may provide some protective advantage.

Concepts: Traumatic brain injury, Vertebral column, Physical trauma, Motorcycle, Motorcycle helmet, Helmet, Bicycle helmet, Helmets

28

Spinal arthrodesis was the first successful treatment for scoliosis, performed by Dr. Russell A. Hibbs in 1911 and later by Dr. Fred H. Albee for tuberculosis. In 1914, Dr. H.P.H. Galloway and Dr. Hibbs began using the method to treat neuromuscular scoliosis in patients with poliomyelitis. However, this treatment approach was plagued by loss of deformity correction over time and high pseudarthrosis rates. The turning point in the operative management of spinal deformities began in 1947 with Dr. Paul Randall Harrington when he started a decade-long process to revolutionize surgical treatment of spinal deformities culminating in the advent of the Harrington Rod, the first successful implantable spinal instrumentation system. During the epoch that he was in practice, Dr. Harrington’s achievement influenced the technology and art of spine surgery for his contemporaries and the coming generations of spine surgeons. The purpose of this article is to review the life of Dr. Harrington, and how he has arguably come to be known as “Father of the Modern Treatment of Scoliosis.”

Concepts: Medicine, Surgery, Vertebral column, Scoliosis, Physician, Orthopedic surgery, Paul Randall Harrington, Harrington implant

28

Vertebral resection with spine shortening has been primarily reported for the treatment of demanding cases of nontraumatic disorders. Recently, this technique has been applied to the treatment of traumatic disorders. The current treatment of vertebral fracture-dislocation when there is partial or total telescoping of the involved vertebrae is a combined anterior-posterior approach with corpectomy, anterior support implant, and further posterior instrumentation. These procedures usually require 2 surgical teams, involve longer operating times and greater risk of surgical complications related to the anterior approach, and commonly entail longer postoperative care before discharge. The authors report on 2 patients with high thoracic fracture-dislocations with telescoping (T-2 and T-4) who were treated in the subacute phase with total spondylectomy (T-3 and T-5, respectively) and spine shortening by using only a posterior approach. Complete recovery of the sagittal balance was achieved with this technique and the postoperative periods were clinically uneventful. One patient presented with asymptomatic hemothorax that did not require drainage. In paraplegic patients with anterior thoracic dislocation fractures in which one vertebral body blocks the reduction of the other, total spondylectomy and spine shortening seem to be a reasonably safe and effective technique.

Concepts: Medical terms, Hospital, Lumbar vertebrae, Vertebral column, Vertebra, Intervertebral disc, Cervical vertebrae, Thoracic vertebrae

28

Object The purpose of the study was to evaluate the safety and initial efficacy of NuQu allogeneic juvenile chondrocytes delivered percutaneously for the treatment of lumbar spondylosis with mechanical low-back pain (LBP). NuQu is a cell-based biological therapy for disc repair. The authors report the results at 12 months of the NuQu Phase I investigational new drug (IND) single-arm, prospective feasibility study for the treatment of LBP for single-level degenerative disc disease (Pfirrman Grades III-IV) at L3-S1. Methods Fifteen patients (6 women and 9 men) were enrolled at 2 sites. Institutional review board approval was obtained, and all patients signed a study-specific informed consent. All patients have completed a minimum of 1 year of follow-up. Patients were evaluated pretreatment and at 1, 3, 6, and 12 months posttreatment. Evaluations included routine neurological examinations, serum liver and renal function studies, MRI, the Oswestry Disability Index (ODI), the Numerical Rating Scale (NRS), and the 36-Item Short Form Health Survey (SF-36). Results Fifteen patients were treated with a single percutaneous delivery of NuQu juvenile chondrocytes. The mean patient age was 40 years (19-47 years). Each treatment consisted of 1-2 ml (mean injection 1.3 ml) of juvenile chondrocytes (approximately 10(7) chondrocyte cells/ml) with fibrin carrier. The mean peak pressure during treatment was 87.6 psi. The treatment time ranged from 5 to 33 seconds. The mean ODI (baseline 53.3, 12-month 20.3; p < 0.0001), NRS (baseline 5.7, 12-month 3.1; p = 0.0025), and SF-36 physical component summary (baseline 35.3, 12-month 46.9; p = 0.0002) scores all improved significantly from baseline. At the 6-month follow-up, 13 patients underwent MRI (one patient underwent CT imaging and another refused imaging). Ten (77%) of these 13 patients exhibited improvements on MRI. Three of these patients showed improvement in disc contour or height. High-intensity zones (HIZs), consistent with posterior anular tears, were present at baseline in 9 patients. Of these, the HIZ was either absent or improved in 8 patients (89%) by 6 months. The HIZ was improved in the ninth patient at 3 months, with no further MRI follow-up. Of the 10 patients who exhibited radiological improvement at 6 months, findings continued to improve or were sustained in 8 patients at the 12-month follow-up. No patient experienced neurological deterioration. There were no disc infections, and there were no serious or unexpected adverse events. Three patients (20%) underwent total disc replacement by the 12-month follow-up due to persistent, but not worse than baseline, LBP. Conclusions This is a 12-month report of the clinical and radiographic results from a US IND study of cell-based therapy (juvenile chondrocytes) in the treatment of lumbar spondylosis with mechanical LBP. The results of this prospective cohort are promising and warrant further investigation with a prospective, randomized, double-blinded, placebo-controlled study design. Clinical trial registration no.: BB-IND 13985.

Concepts: Better, Clinical trial, Improve, Informed consent, Hospital, Degenerative disc disease, Adverse event, Investigational New Drug

28

Object The pathophysiology of occult tethered cord syndrome (OTCS) with no anatomical evidence of a caudally shifted conus and a normal terminal filum is hard to understand. Therefore, the diagnosis of OTCS is often difficult. The authors hypothesized that the posterior displacement of the terminal filum may become prominent in patients with OCTS who are in a prone position if filum inelasticity exists, and they investigated prone-position MRI findings. Methods Fourteen patients with OTCS and 12 control individuals were examined using T2-weighted axial MRI with the patients in a prone position on a flat table. On each axial view, the distance between the posterior and anterior ends of the subarachnoid space (A), the distance between the posterior end of the subarachnoid space and the terminal filum (B), the distance between the posterior end of the subarachnoid space and the dorsal-most nerve among the cauda equina ©, and the distance between the posterior end of the subarachnoid space and the ventral-most nerve (D) were measured. The location ratios of the terminal filum, the dorsal-most nerve, and the ventral-most nerve were calculated by the ratio of A to B (defined as TF = B/A), A to C (defined as DN = C/A), and A to D (defined as VN = D/A), respectively. Patients underwent sectioning of the terminal filum with the aid of a surgical microscope. The low-back pain Japanese Orthopaedic Association score was obtained before surgery and at the final follow-up visit. Results On prone-position axial MRI, the terminal filum was separated from the cauda equina and was shifted caudally to posterior in the subarachnoid space in all patients with OTCS. The locations of the caudal cauda equina shifted to ventral in the subarachnoid space. The TF values in the OTCS group were significantly lower than those in the control group at the L3-4 (p = 0.023), L-4 (p = 0.030), L4-5 (p = 0.002), and L-5 (p < 0.001) levels. In contrast, the DN values in the OTCS group were significantly higher than those of the control group at the L-2 (p = 0.003), L2-3 (p = 0.002), L-3 (p < 0.001), L3-4 (p < 0.001), L-4 (p = 0.007), L4-5 (p = 0.003), and S-1 (p = 0.014) levels, and the VN values in the OTCS group were also significantly higher than those of the control group at the L2-3 (p = 0.022), L-3 (p = 0.027), L3-4 (p = 0.002), L-4 (p = 0.011), L4-5 (p = 0.019), and L5-S1 (p = 0.040) levels. Sections were collected during surgery for histological evaluation, and a decreased elasticity within the terminal filum was suggested. Improvements in the Japanese Orthopaedic Association score were observed at the final follow-up in all patients. Conclusions The authors' new method of using the prone position for MRI shows that the terminal filum is located significantly posterior and the cauda equina is located anterior in patients with OTCS, suggesting a difference in elasticity between the terminal filum and cauda equina.

Concepts: Spinal cord, Nuclear magnetic resonance, Magnetic resonance imaging, Anatomy, Cerebrospinal fluid, Meninges, Cauda equina, Subarachnoid space

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Object The authors undertook this study to evaluate curve progression, risk factors for curve progression, and outcomes after decompression surgery in patients with degenerative lumbar scoliosis with minimal to moderate curvature. Methods Of 852 patients with lumbar canal stenosis treated by posterior decompression surgery, 50 patients had a lumbar curve greater than 10° at final follow-up. These patients were divided into 2 groups according to curve progression during the follow-up period: the P group (11 patients), with a curve progression of more than 5°, and the NP group (39 patients), with a curve progression of 5° or less. The authors compared preoperative parameters in these 2 groups to elucidate risk factors associated with curve progression and other surgical outcomes. Results The average lumbar curve progression in the total group of 50 patients was 3.4° ± 3.9° (range -2.0° to 22.0°). In the P group the average curve progression was 8.5°, and in the NP group it was 2.0°. Multivariate logistic regression analysis showed no significant association between curve progression and any of the potential risk factors evaluated (including curve magnitude, decompression method, and degenerative intervertebral disc changes). Spur formation, evaluated with the Nathan classification at the concave side of the curve, tended to be greater in the P group, although the difference was not statistically significant. There was no significant difference in revision surgery rate, and none of the patients required arthrodesis due to curve progression. Clinical outcomes, evaluated with the Japanese Orthopaedic Association Back Pain Evaluation Questionnaire and the Scoliosis Research Society 22-question questionnaire, were also similar in the 2 groups. Conclusions Surgical outcomes did not deteriorate in the P group. While curve progression after decompression surgery could not be predicted from the preoperative factors considered, spur formation at the concave side of the curve may be a candidate factor. The results of this study indicate that spinal fixation to halt deformity progression is not always necessary if the patient’s pathological condition derives mainly from canal stenosis.

Concepts: Regression analysis, Statistics, Surgery, Statistical significance, Vertebral column, Scoliosis, Paul Randall Harrington, Spinal stenosis

25

OBJECTIVE In an era of escalating health care costs and pressure to improve efficiency and cost of care, ambulatory surgery centers (ASCs) have emerged as lower-cost options for many surgical therapies. Anterior cervical discectomy and fusion (ACDF) is one of the most prevalent spine surgeries performed, and the frequency of its performance is rapidly increasing as the aging population grows. Although ASCs offer significant cost advantages over hospital-based surgical centers, concern over the safety of outpatient ACDF has slowed its adoption. The authors intended to 1) determine the safety of the first 1000 consecutive ACDF surgeries performed in their outpatient ASC, and 2) compare the safety of these outpatient ACDFs with that of consecutive ACDFs performed during the same time period in the hospital setting. METHODS A total of 1000 consecutive patients who underwent ACDF in an ACS (outpatient ACDF) and 484 consecutive patients who underwent ACDF at Vanderbilt University Hospital (inpatient ACDF) from 2006 to 2013 were included in this retrospective study of patients' medical records. Data were collected on patient demographics, comorbidities, operative details, and perioperative and 90-day morbidity. Perioperative morbidity and hospital readmission were compared between the outpatient and inpatient ACDF groups. RESULTS Of the first 1000 outpatient ACDF cases performed in the authors' ASC, 629 (62.9%) were 1-level and 365 (36.5%) were 2-level ACDFs. Mean patient age was 49.5 ± 8.6, and 484 (48.4%) were males. All patients were observed postoperatively at the ASC postanesthesia care unit (PACU) for 4 hours before being discharged home. Eight patients (0.8%) were transferred from the surgery center to the hospital postoperatively (for pain control [n = 3], chest pain and electrocardiogram changes [n = 2], intraoperative CSF leak [n = 1], postoperative hematoma [n = 1], and profound postoperative weakness and surgical reexploration [n = 1]). No perioperative deaths occurred. The 30-day hospital readmission rate was 2.2%. All 90-day surgical morbidity was similar between outpatient and inpatient cohorts for both 1-level and 2-level ACDFs. CONCLUSIONS An analysis of 1000 consecutive patients who underwent ACDF in an outpatient setting demonstrates that surgical complications occur at a low rate (1%) and can be appropriately diagnosed and managed in a 4-hour ASC PACU window. Comparison with an inpatient ACDF surgery cohort demonstrated similar results, highlighting that ACDF can be safely performed in the outpatient ambulatory surgery setting without compromising surgical safety. In an effort to decrease costs of care, surgeons can safely perform 1- and 2-level ACDFs in an ASC environment.

Concepts: Medicine, Patient, Hospital, Surgery, Physician, Anesthesia, Anterior cervical discectomy and fusion, Post anesthesia care unit

24

OBJECT Anterior cervical corpectomy with fusion has become the most widely used procedure for the treatment of multilevel cervical stenosis. Although an autologous bone graft is the gold standard for vertebral replacement after corpectomy, industrial implants have become popular because they result in no donor-site morbidity. In this study, the authors compared clinical and radiological results of autologous iliac grafts versus those of bone-filled polyetherketoneketone (PEKK) cage implants. METHODS The clinical and radiological data of 46 patients with degenerative multilevel cervical stenosis and who underwent 1- or 2-level anterior median corpectomy between 2004 and 2012 were analyzed. The patients in Group 1 were treated with vertebral replacement with an autologous iliac graft, and those in Group 2 were treated with a PEKK cage implant. Each patient also underwent osteosynthesis with an anterior plate-screw system. Visual analog scale (VAS) and European Myelopathy Scale scores, loss of height and regional cervical lordosis angle, and complication rates of the 2 groups were compared. RESULTS The mean follow-up time was 20 months. In both groups, the VAS and European Myelopathy Scale scores improved significantly. The loss of height was 3.7% in patients with iliac grafts and 5.3% in patients with PEKK implants. The rates of osseous fusion were similar in Groups 1 and 2 (94.7% and 91.3%, respectively). At the end of the follow-up period, none of the patients complained about donor-site pain. One patient in Group 1 suffered a fracture of the iliac bone that required osteosynthesis. Four patients in Group 2 had to receive revision surgery for cage and/or plate-screw dislocation and new neurological deficit or intractable pain. CONCLUSIONS Preoperative pain and radicularand myelopathic symptoms improve after decompression irrespective of the material used for vertebral replacement. The use of PEKK cages for vertebral replacement seems to result in a higher risk of implant-related complications. A prospective randomized study is necessary to supply evidence for the use of autografts and artificial implants after anterior cervical corpectomy with fusion.

Concepts: Bone, Randomized controlled trial, Surgery, Skull, Implants, Orthopedic surgery, Arithmetic mean, Bone grafting

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This study was performed to describe the extraforaminal approach of biportal endoscopic spinal surgery (BESS) as a new endoscopic technique for transforaminal decompression and discectomy and to demonstrate the clinical outcomes of this new procedure for the first time. Twenty-one patients (27 segments) who underwent the extraforaminal approach of BESS between March 2015 and April 2016 were enrolled according to the inclusion and exclusion criteria. The operative time (minutes/level) and complications after the procedure were recorded. The visual analog scale (VAS) score was checked to assess the degree of radicular leg pain preoperatively and at the time of the last follow-up. The modified Macnab criteria were used to examine the clinical outcomes at the time of the last follow-up. The mean duration of the follow-up period was 14.8 months (minimum duration 12 months). The mean operative time was 96.7 minutes for one level. The mean VAS score for radicular leg pain dropped from a preoperative score of 7.5 ± 0.9 to a final follow-up score of 2.5 ± 1.2 (p < 0.001). The final outcome according to the modified Macnab criteria was excellent in 5 patients (23.8%), good in 12 (57.2%), fair in 4 (19.0%), and poor in 0. Therefore, excellent or good results (a satisfied outcome) were obtained in 80.9% of the patients. Complications were limited to one dural tear (4.8%). The authors found that the extraforaminal approach of BESS was a feasible and advantageous endoscopic technique for the treatment of foraminal lesions, including stenosis and disc herniation. They suggest that this technique represents a useful, alternative, minimally invasive method that can be used to treat lumbar foraminal stenosis and disc herniation.

Concepts: Spinal disc herniation, Surgery, Hernia, Minimally invasive, Spinal stenosis, Outcome, 2016, 2015

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OBJECTIVE The authors compared the efficacy and safety of arthroplasty using the Prestige LP cervical disc with those of anterior cervical discectomy and fusion (ACDF) for the treatment of degenerative disc disease (DDD) at 2 adjacent levels. METHODS Patients from 30 investigational sites were randomized to 1 of 2 groups: investigational patients (209) underwent arthroplasty using a Prestige LP artificial disc, and control patients (188) underwent ACDF with a cortical ring allograft and anterior cervical plate. Patients were evaluated preoperatively, intraoperatively, and at 1.5, 3, 6, 12, and 24 months postoperatively. Efficacy and safety outcomes were measured according to the Neck Disability Index (NDI), Numeric Rating Scales for neck and arm pain, 36-Item Short-Form Health Survey (SF-36), gait abnormality, disc height, range of motion (investigational) or fusion (control), adverse events (AEs), additional surgeries, and neurological status. Treatment was considered an overall success when all 4 of the following criteria were met: 1) NDI score improvement of ≥ 15 points over the preoperative score, 2) maintenance or improvement in neurological status compared with preoperatively, 3) no serious AE caused by the implant or by the implant and surgical procedure, and 4) no additional surgery (supplemental fixation, revision, or nonelective implant removal). Independent statisticians performed Bayesian statistical analyses. RESULTS The 24-month rates of overall success were 81.4% for the investigational group and 69.4% for the control group. The posterior mean for overall success in the investigational group exceeded that in the control group by 0.112 (95% highest posterior density interval = 0.023 to 0.201) with a posterior probability of 1 for noninferiority and 0.993 for superiority, demonstrating the superiority of the investigational group for overall success. Noninferiority of the investigational group was demonstrated for all individual components of overall success and individual effectiveness end points, except for the SF-36 Mental Component Summary. The investigational group was superior to the control group for NDI success. The proportion of patients experiencing any AE was 93.3% (195/209) in the investigational group and 92.0% (173/188) in the control group, which were not statistically different. The rate of patients who reported any serious AE (Grade 3 or 4) was significantly higher in the control group (90 [47.9%] of 188) than in the investigational group (72 [34.4%] of 209) with a posterior probability of superiority of 0.996. Radiographic success was achieved in 51.0% (100/196) of the investigational patients (maintenance of motion without evidence of bridging bone) and 82.1% (119/145) of the control patients (fusion). At 24 months, heterotopic ossification was identified in 27.8% (55/198) of the superior levels and 36.4% (72/198) of the inferior levels of investigational patients. CONCLUSIONS Arthroplasty with the Prestige LP cervical disc is as effective and safe as ACDF for the treatment of cervical DDD at 2 contiguous levels and is an alternative treatment for intractable radiculopathy or myelopathy at 2 adjacent levels. Clinical trial registration no.: NCT00637156 ( clinicaltrials.gov ).

Concepts: Clinical trial, Statistics, Surgery, Degenerative disc disease, Anterior cervical discectomy and fusion, Discectomy, Christopher Nolan, Intervertebral disc arthroplasty