Category: Spine

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Two-level cervical disc arthroplasty versus anterior cervical discectomy and fusion: 10-year outcomes of a prospective, randomized investigational device exemption clinical trial

J Neurosurg Spine 31:508–518, 2019

The authors assessed the 10-year clinical safety and effectiveness of cervical disc arthroplasty (CDA) to treat degenerative cervical spine disease at 2 adjacent levels compared to anterior cervical discectomy and fusion (ACDF).

METHODS A prospective, randomized, controlled, multicenter FDA-approved clinical trial was conducted comparing the low-profile titanium ceramic composite–based Prestige LP Cervical Disc (n = 209) at two levels with ACDF (n = 188). Ten-year follow-up data from a postapproval study were available on 148 CDA and 118 ACDF patients and are reported here. Clinical and radiographic evaluations were completed preoperatively, intraoperatively, and at regular postoperative follow-up intervals for up to 10 years. The primary endpoint was overall success, a composite variable that included key safety and efficacy considerations. Ten-year follow-up rates were 86.0% for CDA and 84.9% for ACDF.

RESULTS From 2 to 10 years, CDA demonstrated statistical superiority over ACDF for overall success, with rates at 10 years of 80.4% versus 62.2%, respectively (posterior probability of superiority [PPS] = 99.9%). Neck Disability Index (NDI) success was also superior, with rates at 10 years of 88.4% versus 76.5% (PPS = 99.5%), as was neurological success (92.6% vs 86.1%; PPS = 95.6%). Improvements from preoperative results in NDI and neck pain scores were consistently statistically superior for CDA compared to ACDF. All other study effectiveness measures were at least noninferior for CDA compared to ACDF through the 10-year follow-up period, including disc height. Mean angular ranges of motion at treated levels were maintained in the CDA group for up to 10 years. The rates of grade IV heterotopic ossification (HO) at the superior and inferior levels were 8.2% and 10.3%, respectively. The rate of severe HO (grade III or IV) did not increase significantly from 7 years (42.4%) to 10 years (39.0%). The CDA group had fewer serious (grade 3–4) implantrelated or implant/surgical procedure–related adverse events (3.8% vs 8.1%; posterior mean 95% Bayesian credible interval [BCI] of the log hazard ratio [LHR] -0.92 [-1.88, -0.01]). The CDA group also had statistically fewer secondary surgical procedures at the index levels (4.7%) than the ACDF group (17.6%) (LHR [95% BCI] -1.39 [-2.15, -0.61]) as well as at adjacent levels (9.0% vs 17.9%).

CONCLUSIONS The Prestige LP Cervical Disc, implanted at two adjacent levels, maintains improved clinical outcomes and segmental motion 10 years after surgery and is a safe and effective alternative to fusion.

Clinical trial registration no.: NCT00637156 (clinicaltrials.gov)

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Lumbar disc arthroplasty versus anterior lumbar interbody fusion: 5-year outcomes for patients in the Maverick disc investigational device exemption study

J Neurosurg Spine 31:347–356, 2019

Despite evidence of its safety and effectiveness, the use of lumbar disc arthroplasty has been slow to expand due in part to concerns about late complications and the risks of revision surgery associated with early devices. More recently, FDA approval of newer devices and improving reimbursements have reversed this trend in the United States. Additional long-term data on lumbar disc arthroplasty are still needed. This study reports the 5-year results of the FDA investigational device exemption clinical trial of the Medtronic Spinal and Biologics’ Maverick total disc replacement.

METHODS Patients with single-level degenerative disc disease from L4 to S1 were randomized 2:1 at 31 investigational sites. In the period from April 2003 to August 2004, 405 patients received the investigational device and 172 patients underwent the control procedure of anterior lumbar interbody fusion. Outcome measures included the Oswestry Disability Index (ODI), numeric rating scales (NRSs) for back and leg pain, the SF-36, disc height, interbody motion, heterotopic ossification (investigational device), adverse events (AEs), additional surgeries, and neurological status. Treatment was considered an overall success when all of the following criteria were met: 1) ODI score improvement ≥ 15 points over the preoperative score; 2) maintenance or improvement in neurological status compared with preoperatively; 3) disc height success, that is, no more than a 2-mm reduction in anterior or posterior height; 4) no serious AEs caused by the implant or by the implant and the surgical procedure; and 5) no additional surgery classified as a failure.

RESULTS Compared to that in the control group, improvement in the investigational group was statistically greater according to the ODI and SF-36 Physical Component Summary (PCS) at 1, 2, and 5 years; the NRS for back pain at 1 and 2 years; and the NRS for leg pain at 1 year. The rates of heterotopic ossification increased over time: 1.0% (4/382) at 1 year, 2.6% (9/345) at 2 years, and 5.9% (11/187) at 5 years. Investigational patients had fewer device-related AEs and serious device-related AEs than the control patients at both 2 and 5 years postoperatively. Noninferiority of the composite measure overall success was demonstrated at all follow-up intervals; superiority was demonstrated at 1 and 2 years.

CONCLUSIONS Lumbar disc arthroplasty is a safe and effective treatment for single-level lumbar degenerative disc disease, resulting in improved physical function and reduced pain up to 5 years after surgery.

Clinical trial registration no.: NCT00635843 (clinicaltrials.gov)

 

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Management of perineural (Tarlov) cysts: a population-based cohort study and algorithm for the selection of surgical candidates

Acta Neurochirurgica (2019) 161:1909–1915 

Perineural cysts, also known as Tarlov cysts, are cerebrospinal fluid-filled growths that develop at the intersection of a dorsal root ganglion and posterior nerve root. They are typically an asymptomatic and incidental finding during routine spine imaging. For symptomatic perineural cysts, there is little evidence on which treatment is most effective or when it is indicated. The aim of this study was to review our experience from a population-based cohort of patients with symptomatic perineural cysts and to propose an algorithm that could be used in the selection of surgical candidates.

Methods A retrospective review was conducted of all adult (≥ 15 years) patients with symptomatic perineural cysts who were referred to Karolinska University Hospital between 2002 and 2018.

Results Thirty-nine patients were included. The most common symptom was sciatica (n = 22). Cyst aspiration was performed in 28 patients, 24 of whom showed clinical improvement and were offered surgery. Microsurgical cyst fenestration was performed in 17 patients, 16 of whom showed clinical improvement at long-term follow-up. There were no surgical complications. Ten of the patients who were offered surgery chose to be treated conservatively instead, four of whom showed progression of symptoms at long-term follow-up.

Conclusions Microsurgical cyst fenestration seems to be a safe and effective option for symptomatic relief in patients with perineural cysts. Based on the results from our series and those of others, we propose an algorithm for the selection of surgical candidates.

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Postoperative Rigid Cervical Collar Leads to Less Axial Neck Pain in the Early Stage After Open-Door Laminoplasty—A Single-Blinded Randomized Controlled Trial

Neurosurgery, Volume 85, Issue 3, September 2019, Pages 325–334

Cervical collars are used after laminoplasty to protect the hinge opening, reduce risks of hinge fractures, and avoid spring-back phenomena. However, their usemay lead to reduced range of motion and worse neck pain.

OBJECTIVE: To investigate the clinical, radiological, and functional outcomes of patients undergoing single-door laminoplasty with or without collar immobilization.

METHODS: This was a prospective, parallel, single-blinded randomized controlled trial. Patients underwent standardized single-door laminoplasty with mini-plates for cervical myelopathy and were randomly allocated into 2 groups based on the use of collar postoperatively. Clinical assessments included cervical range of motion, axial neck pain (VAS [visual analogue scale]), and objective scores (short-form 36-item, neck disability index, andmodified Japanese Orthopaedic Association). All assessmentswere performed preoperativelyandatpostoperative 1, 2, 3, and 6 wk, and 3, 6, and 12 mo. Comparative analysis was performed via analysis of variance adjusted by baseline scores, sex, and age as covariates.

RESULTS: A total of 35 patients were recruited and randomized to collar use (n = 16) and without (n = 19). There were no dropouts or complications. There were no differences between groups at baseline. Subjects had comparable objective scores and range of motion at postoperative time-points. Patientswithout collar use had higher VAS at postoperative 1 wk (5.4 vs 3.5; P = .038) and 2 wk (3.5 vs 1.5; P = .028) but subsequently follow-up revealed no differences between the 2 groups.

CONCLUSION: The use of a rigid collar after laminoplasty leads to less axial neck pain in the first 2 wk after surgery. However, there is no additional benefit with regards to range of motion, quality of life, and complication risk.

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Ultra-Early (<12 Hours) Surgery Correlates With Higher Rate of American Spinal Injury Association Impairment Scale Conversion After Cervical Spinal Cord Injury

Neurosurgery, Volume 85, Issue 2, August 2019, Pages 199–203

Cervical spinal cord injury (SCI) is a devastating condition with very few treatment options. It remains unclear if early surgery correlated with conversion of American Spinal Injury Association Impairment Scale (AIS) grade A injuries to higher grades.

OBJECTIVE: To determine the optimal time to surgery after cervical SCI through retrospective analysis.

METHODS: We collected data from 48 patients with cervical SCI. Based on the time from Emergency Department (ED) presentation to surgical decompression, we grouped patients into ultra-early (decompression within 12 h of presentation), early (within 12- 24 h), and late groups (>24 h).We compared the improvement in AIS grade fromadmission to discharge, controlling for confounding factors such as AIS grade on admission, injury severity, and age. The mean time from injury to ED for this group of patients was 17 min.

RESULTS: Patients who received surgery within 12 h after presentation had a relative improvement in AIS grade from admission to discharge: the ultra-early group improved on average 1.3. AIS grades compared to 0.5 in the early group (P = .02). In addition, 88.8% of patients with an AIS grade A converted to a higher grade (AIS B or better) in the ultraearly group, compared to 38.4% in the early and late groups (P= .054).

CONCLUSION: These data suggest that surgical decompression after SCI that takes place within 12 hmay lead to a relative improved neurological recovery compared to surgery that takes place after 12 h.

 

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Outcome of unilateral versus standard open midline approach for bilateral decompression in lumbar spinal stenosis: is “over the top” really better?

J Neurosurg Spine 31:236–245, 2019

In this retrospective analysis of a prospective multicenter cohort study, the authors assessed which surgical approach, 1) the unilateral laminotomy with bilateral spinal canal decompression (ULBD; also called “over the top”) or 2) the standard open bilateral decompression (SOBD), achieves better clinical outcomes in the long-term follow-up. The optimal surgical approach (ULBD vs SOBD) to treat lumbar spinal stenosis remains controversial.

METHODS The main outcomes of this study were changes in a spinal stenosis measure (SSM) symptoms score, SSM function score, and quality of life (sum score of the 3-level version of the EQ-5D tool [EQ-5D-3L]) over time. These outcome parameters were measured at baseline and at 12-, 24-, and 36-month follow-ups. To obtain an unbiased result on the effect of ULBD compared to SOBD the authors used matching techniques relying on propensity scores. The latter were calculated based on a logistic regression model including relevant confounders. Additional outcomes of interest were raw changes in main outcomes and in the Roland and Morris Disability Questionnaire from baseline to 12, 24, and 36 months.

RESULTS For this study, 277 patients met the inclusion criteria. One hundred forty-nine patients were treated by ULBD, and 128 were treated by SOBD. After propensity score matching, 128 patients were left in each group. In the matched cohort, the mean (95% CI) estimated differences between ULBD and SOBD for change in SSM symptoms score from baseline to 12 months were -0.04 (-0.25 to 0.17), to 24 months -0.07 (-0.29 to 0.15), and to 36 months -0.04 (-0.28 to 0.21). For change in SSM function score, the estimated differences from baseline to 12 months were 0.06 (-0.08 to 0.21), to 24 months 0.08 (-0.07 to 0.22), and to 36 months 0.01 (-0.16 to 0.17). Differences in changes between groups in EQ-5D-3L sum scores were estimated to be -0.32 (-4.04 to 3.40), -0.89 (-4.76 to 2.98), and -2.71 (-7.16 to 1.74) from baseline to 12, 24, and 36 months, respectively. None of the group differences between ULBD and SOBD were statistically significant.

CONCLUSIONS Both surgical techniques, ULBD and SOBD, may provide effective treatment options for DLSS patients. The authors further determined that the patient outcome results for the technically more challenging ULBD seem not to be superior to those for the SOBD even after 3 years of follow-up.

 

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Emergency Department Visits After Elective Spine Surgery

Neurosurgery, Volume 85, Issue 2, August 2019, Pages E258–E265

Emergency department (ED) overuse is a costly and often neglected source of postdischarge resource utilization after spine surgery. Failing to investigate drivers of ED visits represents a missed opportunity to improve the value of care in spine patients.

OBJECTIVE: To identify the prevalence, drivers, and timing of ED visits following elective spine surgery.

METHODS: Patients undergoing elective spine surgery for degenerative disease at a major medical center were enrolled in a prospective longitudinal registry. Patient and surgery characteristics, and patient-reported outcomes were recorded at baseline and 3 mo after surgery, along with self-reported 90-d ED visits. A multivariable regression model was used to identify independent factors associated with 90-d ED visits. For a sample of patients presenting to our institution’s ED, charts were reviewed to identify the reason and time to ED postdischarge.

RESULTS: Of 2762 patients, we found a 90-d ED visit rate of 9.4%. One-third of patients presented to our institution’s ED and of these, 70% presented due to pain or medical concerns at 9 and 7 d postdischarge, respectively, with 60% presenting outside normal clinic hours. Independent risk factors for 90-d ED visits included younger age, preoperative opioid use, chronic obstructive pulmonary disorder, and more vertebral levels involved.

CONCLUSION: Nearly 10% of elective spine patients had 90-d ED visits not requiring readmission. Pain and medical concerns accounted for 70% of visits at our center, occurring within 10 d of discharge. This study provides the clinical details and a timeline necessary to guide individualized interventions to prevent unnecessary, costly ED visits after spine surgery.

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Intrathecal Morphine Following Lumbar Fusion: A Randomized, Placebo-Controlled Trial

Neurosurgery, Volume 85, Issue 2, August 2019, Pages 189–198

Despite the potential for faster postoperative recovery and the ease of direct intraoperative injection, intrathecal morphine is rarely provided in lumbar spine surgery.

OBJECTIVE: To evaluate the safety and efficacy of intrathecal morphine following lumbar fusion.

METHODS: We randomly assigned 150 patients undergoing elective instrumented lumbar fusion to receive a single intrathecal injection of morphine (0.2 mg) or placebo (normal saline) immediately prior to wound closure. The primary outcome was pain on the visual- analogue scale during the first 24 h after surgery. Secondary outcomes included respiratory depression, treatment-related side effects, postoperative opioid requirements, and length of hospital stay. An intention-to-treat, repeated-measures analysis was used to estimate outcomes according to treatment in the primary analysis.

RESULTS: The baseline characteristics of the 2 groups were similar. Intrathecal morphine reduced pain both at rest (32% area under the curves [AUCs] difference, P < .01) and with movement (22% AUCs difference, P < .02) during the initial 24 h after surgery. The risk of respiratory depression was not increased by intrathecal morphine (hazard ratio, 0.86; 95% confidence interval, 0.44 to 1.68; P = .66). Although postoperative opioid requirements were reduced with intrathecal morphine (P < .03), lengths of hospital stay were similar (P = .32). Other than a trend towards increased intermittent catheterization among patients assigned to intrathecal morphine (P = .09), treatment-related side effects did not significantly differ. The early benefits of intrathecal morphine on postoperative pain were no longer apparent after 48 h.

CONCLUSION: A single intrathecal injection of 0.2 mg of morphine safely reduces postoperative pain following lumbar fusion.

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Need for arthrodesis following facetectomy for spinal peripheral nerve sheath tumors

J Neurosurg Spine 31:112–122, 2019

Spinal peripheral nerve sheath tumors (PNSTs) are a group of rare tumors originating from the nerve and its supporting structures. Standard surgical management typically entails laminectomy with or without facetectomy to gain adequate tumor exposure. Arthrodesis is occasionally performed to maintain spinal stability and mitigate the risk of postoperative deformity, pain, or neurological deficit. However, the factors associated with the need for instrumentation in addition to PNST resection in the same setting remain unclear.

METHODS An institutional tumor registry at a tertiary care center was queried for patients treated surgically for a primary diagnosis of spinal PNST between 2002 and 2016. An analysis focused on patients in whom a facetectomy was performed during the resection. The addition of arthrodesis at the index procedure comprised the primary outcome. The authors also recorded baseline demographics, tumor characteristics, and surgery-related variables. Logistic regression was used to identify factors associated with increased risk of fusion surgery.

RESULTS A total of 163 patients were identified, of which 56 (32 had facetectomy with fusion, 24 had facetectomy alone) were analyzed. The median age was 48 years, and 50% of the cohort was female. Age, sex, and race, as well as tumor histology and size, were evenly distributed between patients who received facetectomy alone and those who had facetectomy and fusion. On univariate analysis, total versus subtotal facetectomy (OR 9.0, 95% CI 2.01–64.2; p = 0.009) and cervicothoracic versus other spinal region (OR 9.0, 95% CI 1.51–172.9; p = 0.048) were significantly associated with increased odds of performing immediate fusion. On multivariable analysis, only the effect of total facetectomy remained statistically significant (OR 6.75, 95% CI 1.47–48.8; p = 0.025).

CONCLUSIONS The authors found that total facetectomy and cervicothoracic involvement may be highly associated with the need for concomitant arthrodesis at the time of index surgery. These findings may help surgeons to determine the best surgical planning for patients with PNST.

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Three-year results from a randomized trial of lumbar discectomy with annulus fibrosus occlusion in patients at high risk for reherniation

Acta Neurochirurgica (2019) 161:1389–1396

A larger defect in the annulus fibrosus following lumbar discectomy is a well-known risk factor for reherniation. Procedures intended to prevent reherniation by sealing or occluding the annular defect warrant study in high-risk patients. This study sought to determine 3-year results of lumbar discectomy with a bone-anchored annular closure device (ACD) or lumbar discectomy only (controls) in patients at high risk for reherniation.

Methods This multicenter randomized trial enrolled patients with sciatica due to lumbar intervertebral disc herniation who failed conservative treatment. Patients with large annular defects after lumbar limited microdiscectomy were intraoperatively randomly assigned to receive ACD or control. Clinical and imaging follow-up was performed at routine intervals over 3 years. Main outcomes included rate of reherniations, reoperations, and endplate changes; leg and back pain scores on a visual analogue scale; Oswestry Disability Index (ODI); Physical Component Summary (PCS) and Mental Component Summary (MCS) scores from the SF-36; and adverse events adjudicated by a data safety monitoring board.

Results Among 554 randomized patients, the modified intent-to-treat population consisted of 272 patients in which ACD implantation was attempted and 278 receiving control; device implantation was not attempted in 4 patients assigned to ACD. Outcomes at 3 years favored ACD for symptomatic reherniation (14.8% vs. 29.5%; P < 0.001), reoperation (11.0% vs. 19.3%; P = 0.007), leg pain (21 vs. 30; P < 0.01), back pain (23 vs. 30; P = 0.01), ODI (18 vs. 23; P = 0.02), PCS (47 vs. 44; P < 0.01), and MCS (52 vs. 49; P < 0.01). The frequency of all-cause serious adverse events was comparable between groups (42.3% vs. 44.5%; P = 0.61).

Conclusions The addition of a bone-anchored ACD in patients with large annular defects following lumbar discectomy reduces the risk of reherniation and reoperation, and has a similar safety profile over 3-year follow-up compared with lumbar limited discectomy only.

 

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Investigating the utility of intraoperative neurophysiological monitoring for anterior cervical discectomy and fusion: analysis of over 140,000 cases from the National (Nationwide) Inpatient Sample data set

J Neurosurg Spine 31:76–86, 2019

Intraoperative neurophysiological monitoring (IONM) is a useful adjunct in spine surgery, with proven benefit in scoliosis-correction surgery. However, its utility for anterior cervical discectomy and fusion (ACDF) is unclear, as there are few head-to-head comparisons of ACDF outcomes with and without the use of IONM. The authors sought to evaluate the impact of IONM on the safety and cost of ACDF.

METHODS This was a retrospective analysis of data from the National (Nationwide) Inpatient Sample of the Healthcare Cost and Utilization Project from 2009 to 2013. Patients with a primary procedure code for ACDF were identified, and diagnosis codes were searched to identify cases with postoperative neurological complications. The authors performed univariate and multivariate logistic regression for postoperative neurological complications with use of IONM as the in- dependent variable; additional covariates included age, sex, surgical indication, multilevel fusion, Charlson Comorbidity Index (CCI) score, and admission type. They also conducted propensity score matching in a 1:1 ratio (nearest neighbor) with the use of IONM as the treatment indicator and the aforementioned variables as covariates. In the propensity score–matched cohort, they compared neurological complications, length of stay (LOS), and hospital charges (in US dollars).

RESULTS A total of 141,007 ACDF operations were identified. IONM was used in 9540 cases (6.8%). No significant association was found between neurological complications and use of IONM on univariate analysis (OR 0.80, p = 0.39) or multivariate regression (OR 0.82, p = 0.45). By contrast, age ≥ 65 years, multilevel fusion, CCI score > 0, and a non- elective admission were associated with greater incidence of neurological complication. The propensity score–matched cohort consisted of 18,760 patients who underwent ACDF with (n = 9380) or without (n = 9380) IONM. Rates of neurological complication were comparable between IONM and non-IONM (0.17% vs 0.22%, p = 0.41) groups. IONM and non-IONM groups had a comparable proportion of patients with LOS ≥ 2 days (19% vs 18%, p = 0.15). The use of IONM was associated with an additional $6843 (p < 0.01) in hospital charges.

CONCLUSIONS The use of IONM was not associated with a reduced rate of neurological complications following ACDF. Limitations of the data source precluded a specific assessment of the effectiveness of IONM in preventing neuro- logical complications in patients with more complex pathology (i.e., ossification of the posterior longitudinal ligament or cervical deformity).

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Augmented reality–assisted pedicle screw insertion

J Neurosurg Spine 31:139–146, 2019

Augmented reality (AR) is a novel technology that has the potential to increase the technical feasibility, accuracy, and safety of conventional manual and robotic computer-navigated pedicle insertion methods. Visual data are directly projected to the operator’s retina and overlaid onto the surgical field, thereby removing the requirement to shift attention to a remote display. The objective of this study was to assess the comparative accuracy of AR-assisted pedicle screw insertion in comparison to conventional pedicle screw insertion methods.

METHODS Five cadaveric male torsos were instrumented bilaterally from T6 to L5 for a total of 120 inserted pedicle screws. Postprocedural CT scans were obtained, and screw insertion accuracy was graded by 2 independent neuroradiologists using both the Gertzbein scale (GS) and a combination of that scale and the Heary classification, referred to in this paper as the Heary-Gertzbein scale (HGS). Non-inferiority analysis was performed, comparing the accuracy to freehand, manual computer-navigated, and robotics-assisted computer-navigated insertion accuracy rates reported in the literature. User experience analysis was conducted via a user experience questionnaire filled out by operators after the procedures.

RESULTS The overall screw placement accuracy achieved with the AR system was 96.7% based on the HGS and 94.6% based on the GS. Insertion accuracy was non-inferior to accuracy reported for manual computer-navigated pedicle insertion based on both the GS and the HGS scores. When compared to accuracy reported for robotics-assisted computer-navigated insertion, accuracy achieved with the AR system was found to be non-inferior when assessed with the GS, but superior when assessed with the HGS. Last, accuracy results achieved with the AR system were found to be superior to results obtained with freehand insertion based on both the HGS and the GS scores. Accuracy results were not found to be inferior in any comparison. User experience analysis yielded “excellent” usability classification.

CONCLUSIONS AR-assisted pedicle screw insertion is a technically feasible and accurate insertion method.

 

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Effectiveness of anterior cervical discectomy with or without interbody fusion and arthroplasty in the treatment of cervical disc herniation; a double-blinded randomised controlled trial

The Spine J Volume 19, Issue 6, Pages 965–975. 2019

Motion preserving anterior cervical disc arthroplasty (ACDA) in patients with cervical radiculopathy was introduced to prevent symptomatic adjacent disc degeneration as compared to anterior cervical discectomy and fusion (ACDF). Prior reports suggest that ACDF is not more effective than anterior cervical discectomy (ACD) alone for the treatment of cervical radiculopathy.

Purpose: To evaluate whether patients with cervical radiculopathy due to a herniated disc benefit more from undergoing ACDA, ACDF, or ACD in terms of clinical outcome measured by the Neck Disability Index (NDI).

Study design: Double-blinded randomized controlled trial

Methods: One hundred-nine patients with one level herniated disc were randomized to one of the following treatments: ACDA, ACDF with intervertebral cage, ACD without fusion. Clinical and radiological outcome was measured by NDI, Visual Analogue Scale (VAS) neck pain, VAS arm pain, SF36, EQ-5D, patients’ self-reported perceived recovery, radiographic cervical curvature, and adjacent segment degeneration (ASD) parameters at baseline and until two years after surgery. BBraun Medical paid €298.837 to cover the costs for research nurses.

Results: The NDI declined from 41 to 47 points at baseline to 19±15 in the ACD group, 19± 18 in the ACDF group, and 20±22 in the ACDA group after surgery (p=0.929). VAS arm and neck pain declined to half its baseline value and decreased below the critical value of 40 mm. Quality of life, measured by the EQ-5D, increased in all three groups. ASD parameters were comparable in all three groups as well. No statistical differences were demonstrated between the treatment groups.

Conclusions: The hypothesis that ACDA would lead to superior clinical outcome in comparison to ACDF or ACD could not be confirmed during a two-year follow-up time period. Single level ACD without implanting an intervertebral device may be a reasonable alternative to ACDF or ACDA.

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Is achieving optimal spinopelvic parameters necessary to obtain substantial clinical benefit?

J Neurosurg Spine 30:833–838, 2019

It is now well accepted that spinopelvic parameters are correlated with clinical outcomes in adult spinal deformity (ASD). The purpose of this study was to determine whether obtaining optimal spinopelvic alignment was absolutely necessary to achieve a minimum clinically important difference (MCID) or substantial clinical benefit (SCB).

METHODS A multicenter retrospective review of patients who underwent less-invasive surgery for ASD was conducted. Inclusion criteria were age ≥ 18 years and one of the following: coronal Cobb angle > 20°, sagittal vertical axis (SVA) > 5 cm, pelvic tilt (PT) > 20°, or pelvic incidence to lumbar lordosis (PI-LL) mismatch > 10°. A total of 223 patients who were treated with circumferential minimally invasive surgery or hybrid surgery and had a minimum 2-year follow-up were identified. Based on optimal spinopelvic parameters (PI-LL mismatch ± 10° and SVA < 5 cm), patients were divided into aligned (AL) or malaligned (MAL) groups. The primary clinical outcome studied was the Oswestry Disability Index (ODI) score.

RESULTS There were 74 patients in the AL group and 149 patients in the MAL group. Age and body mass index were similar between groups. Although the baseline SVA was similar, PI-LL mismatch (9.9° vs 17.7°, p = 0.002) and PT (19° vs 24.7°, p = 0.001) significantly differed between AL and MAL groups, respectively. As expected postoperatively, the AL and MAL groups differed significantly in PI-LL mismatch (-0.9° vs 13.1°, p < 0.001), PT (14° vs 25.5°, p = 0.001), and SVA (11.8 mm vs 48.3 mm, p < 0.001), respectively. Notably, there was no difference in the proportion of AL or MAL patients in whom an MCID (52.75% vs 61.1%, p > 0.05) or SCB (40.5% vs 46.3%, p > 0.05) was achieved for ODI score, respectively. Similarly, no differences in percentage of patients obtaining an MCID or SCB for visual analog scale back and leg pain score were observed. On multivariate analysis controlling for surgical and preoperative demographic differences, achieving optimal spinopelvic parameters was not associated with achieving an MCID (OR 0.645, 95% CI 0.31–1.33) or an SCB (OR 0.644, 95% CI 0.31–1.35) for ODI score.

CONCLUSIONS Achieving optimal spinopelvic parameters was not a predictor for achieving an MCID or SCB. Since spinopelvic parameters are correlated with clinical outcomes, the authors’ findings suggest that the presently accepted optimal spinopelvic parameters may require modification. Other factors, such as improvement in neurological symptoms and/or segmental instability, also likely impacted the clinical outcomes.

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Oblique lumbar interbody fusion at L5S1(OLIF51)

Acta Neurochirurgica (2019) 161:1079–1083

OLIF51 retains the advantages of traditional ALIF procedure with good fusion rates and improvement in radiographic parameters and reduces its drawbacks. It has the added advantage of being a minimal access technique.

Methods Preoperative analysis of the vascular anatomy using CT angiography is mandatory. OLIF51 is done in right lateral position using specialized retractor blades and Thompson retractor system. The procedure is similar to OLIF at other levels except for the differences described here. The instruments are specialized for OLIF at L5S1.

Conclusion OLIF51 provides an excellent alternative to traditional ALIF

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Surgical Resection With Radiation Treatment Planning of Spinal Tumors

Neurosurgery, Volume 84, Issue 6, June 2019, Pages 1242–1250

The clinical paradigm for spinal tumors with epidural involvement is challenging considering the rigid dose tolerance of the spinal cord. One effective approach involves open surgery for tumor resection, followed by stereotactic body radiotherapy (SBRT). Resection extent is often determined by the neurosurgeon’s clinical expertise, without considering optimal subsequent post-operative SBRT treatment.

OBJECTIVE: To quantify the effect of incremental epidural disease resection on tumor coverage for spine SBRT in an effort toworking towards integrating radiotherapy planning within the operating room.

METHODS: Ten patients having undergone spinal separation surgery with postoperative SBRTwere retrospectively reviewed. Preoperative magnetic resonance imaging was coregistered to postoperative planning computed tomography to delineate the preoperative epidural disease gross tumor volume (GTV). The GTV was digitally shrunk by a series of fixed amounts away from the cord (up to 6 mm) simulating incremental tumor resection and reflecting an optimal dosimetric endpoint. The dosimetric effect on simulated GTVs was analyzed using metrics such as minimum biologically effective dose (BED) to 95% of the simulated GTV (D95) and compared to the unresected epidural GTV.

RESULTS: Epidural GTV D95 increased at an average rate of 0.88 ± 0.09 Gy10 per mm of resected disease up to the simulated 6 mm limit. Mean BED to D95 was 5.3 Gy10 (31.2%) greater than unresected cases. Allmetrics showed strong positive correlationswith increasing tumor resection margins (R2: 0.989-0.999, P< .01).

CONCLUSION: Spine separation surgery provides division between the spinal cord and epidural disease, facilitating better disease coverage for subsequent post-operative SBRT. By quantifying the dosimetric advantage prior to surgery on actual clinical cases, targeted surgical planning can be implemented.

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Safety and accuracy of robot-assisted versus fluoroscopy-assisted pedicle screw insertion in thoracolumbar spinal surgery

J Neurosurg Spine 30:615–622, 2019

The object of this study was to compare the safety and accuracy of pedicle screw placement using the TiRobot system versus conventional fluoroscopy in thoracolumbar spinal surgery.

METHODS Patients with degenerative or traumatic thoracolumbar spinal disorders requiring spinal instrumentation were randomly assigned to either the TiRobot-assisted group (RG) or the freehand fluoroscopy-assisted group (FG) at a 1:1 ratio. The primary outcome measure was the accuracy of screw placement according to the Gertzbein-Robbins scale; grades A and B (pedicle breach < 2 mm) were considered clinically acceptable. In the RG, discrepancies between the planned and actual screw placements were measured by merging postoperative CT images with the trajectory planning images. Secondary outcome parameters included proximal facet joint violation, duration of surgery, intraoperative blood loss, conversion to freehand approach in the RG, postoperative hospital stay, and radiation exposure.

RESULTS A total of 1116 pedicle screws were implanted in 234 patients (119 in the FG, and 115 in the RG). In the RG, 95.3% of the screws were perfectly positioned (grade A); the remaining screws were graded B (3.4%), C (0.9%), and D (0.4%). In the FG, 86.1% screws were perfectly positioned (grade A); the remaining screws were graded B (7.4%), C (4.6%), D (1.4%), and E (0.5%). The proportion of clinically acceptable screws was significantly greater in the RG than in the FG (p < 0.01). In the RG, the mean deviation was 1.5 ± 0.8 mm for each screw. The most common direction of screw deviation was lateral in the RG and medial in the FG. Two misplaced screws in the FG required revision surgery, whereas no revision was required in the RG. None of the screws in the RG violated the proximal facet joint, whereas 12 screws (2.1%) in the FG violated the proximal facet joint (p < 0.01). The RG had significantly less blood loss (186.0 ± 255.3 ml) than the FG (217.0 ± 174.3 ml; p < 0.05). There were no significant differences between the two groups in terms of surgical time and postoperative hospital stay. The mean cumulative radiation time was 81.5 ± 38.6 seconds in the RG and 71.5 ± 44.2 seconds in the FG (p = 0.07). Surgeon radiation exposure was significantly less in the RG (21.7 ± 11.5 μSv) than in the FG (70.5 ± 42.0 μSv; p < 0.01).

CONCLUSIONS TiRobot-guided pedicle screw placement is safe and useful in thoracolumbar spinal surgery. Clinical trial registration no.: NCT02890043 (clinicaltrials.gov)

 

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Utility of Cervical Collars Following Cervical Fusion Surgery. Does It Improve Fusion Rates or Outcomes?

World Neurosurg. (2019) https://doi.org/10.1016/j.wneu.2018.12.066

The use of postoperative cervical collars following cervical fusions is common practice. Its use has been purported to improve fusion rates and outcomes. There is a paucity in the strength of evidence to support its clinical benefit. Our objective is to critically evaluate the published literature to determine the strength of evidence supporting the use of postoperative cervical collar use following cervical fusions.

METHODS: A systematic review using Preferred Reporting Items for Systematic Reviews and Meta-Analyses (also known as PRISMA) was performed. An online search using Medline and Cochrane Central Register of Controlled Trials databases was used to query prospective and retrospective clinical trials evaluating cervical fusions with or without postoperative collar.

RESULTS: The search identified 894 articles in Medline and 65 articles in the Cochrane database. From these articles, 130 were selected based on procedure and collar use. Only 3 studies directly compared between collar use and no collar use. Our analysis of the mean improvement in neck disability index scores and improvement over time intervals did not show a statistically significant difference between collar versus no collar (P [ 0.86).

CONCLUSIONS: We found no strong evidence to support the use of cervical collars after 1- and 2-level anterior cervical discectomy and fusion procedures, and no studies comparing collar use and no collar use after posterior cervical fusions. Given the cost and likely impact of collar use on driving and the return to work, our study shows that currently there is no proven benefit to routine use of postoperative cervical collar in patients undergoing 1- and 2-level anterior cervical discectomy and fusion for degenerative cervical pathologies.

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Pedicle Screw Placement Using Augmented Reality Surgical Navigation With Intraoperative 3D Imaging

Spine 2019;44:517–525

The aim of this study was to evaluate the accuracy of pedicle screw placement using augmented reality surgical navigation (ARSN) in a clinical trial.

Summary of Background Data. Recent cadaveric studies have shown improved accuracy for pedicle screw placement in the thoracic spine using ARSN with intraoperative 3D imaging, without the need for periprocedural x-ray. In this clinical study, we used the same system to place pedicle screws in the thoracic and lumbosacral spine of 20 patients.

Methods. The study was performed in a hybrid operating room with an integrated ARSN system encompassing a surgical table, a motorized flat detector C-arm with intraoperative 2D/3D capabilities, integrated optical cameras for augmented reality navigation, and noninvasive patient motion tracking. Three independent reviewers assessed screw placement accuracy using the Gertzbein grading on 3D scans obtained before wound closure. In addition, the navigation time per screw placement was measured.

Results. One orthopedic spinal surgeon placed 253 lumbosacral and thoracic pedicle screws on 20 consenting patients scheduled for spinal fixation surgery. An overall accuracy of 94.1% of primarily thoracic pedicle screws was achieved. No screws were deemed severely misplaced (Gertzbein grade 3). Fifteen (5.9%) screws had 2 to 4mm breach (Gertzbein grade 2), occurring in scoliosis patients only. Thirteen of those 15 screws were larger than the pedicle in which they were placed. Two medial breaches were observed and 13 were lateral. Thirteen of the grade 2 breaches were in the thoracic spine. The average screw placement time was 5.24.1 minutes. During the study, no device-related adverse event occurred. Conclusion. ARSN can be clinically used to place thoracic and lumbosacral pedicle screws with high accuracy and with acceptable navigation time. Consequently, the risk for revision surgery and complications could be minimized. Key words: augmented reality, image-guided surgery, intraoperative 3D cone beam computed tomography imaging, pedicle screw accuracy, scoliosis.

Level of Evidence: 3

 

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Complications for minimally invasive lateral interbody arthrodesis: a systematic review and meta-analysis comparing prepsoas and transpsoas approaches

J Neurosurg Spine 30:446–460, 2019

Minimally invasive anterolateral retroperitoneal approaches for lumbar interbody arthrodesis have distinct advantages attractive to spine surgeons. Prepsoas or transpsoas trajectories can be employed with differing complication profiles because of the inherent anatomical differences encountered in each approach. The evidence comparing them remains limited because of poor quality data. Here, the authors sought to systematically review the available literature and perform a meta-analysis comparing the two techniques.

METHODS A systematic review and meta-analysis was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. A database search was used to identify eligible studies. Prepsoas and transpsoas studies were compiled, and each study was assessed for inclusion criteria. Complication rates were recorded and compared between approach groups. Studies incorporating an analysis of postoperative subsidence and pseudarthrosis rates were also assessed and compared.

RESULTS For the prepsoas studies, 20 studies for the complications analysis and 8 studies for the pseudarthrosis outcomes analysis were included. For the transpsoas studies, 39 studies for the complications analysis and 19 studies for the pseudarthrosis outcomes analysis were included. For the complications analysis, 1874 patients treated via the prepsoas approach and 4607 treated with the transpsoas approach were included. In the transpsoas group, there was a higher rate of transient sensory symptoms (21.7% vs 8.7%, p = 0.002), transient hip flexor weakness (19.7% vs 5.7%, p < 0.001), and permanent neurological weakness (2.8% vs 1.0%, p = 0.005). A higher rate of sympathetic nerve injury was seen in the prepsoas group (5.4% vs 0.0%, p = 0.03). Of the nonneurological complications, major vascular injury was significantly higher in the prepsoas approach (1.8% vs 0.4%, p = 0.01). There was no difference in urological or peritoneal/bowel injury, postoperative ileus, or hematomas (all p > 0.05). A higher infection rate was noted for the trans-psoas group (3.1% vs 1.1%, p = 0.01). With regard to postoperative fusion outcomes, similar rates of subsidence (12.2% prepsoas vs 13.8% transpsoas, p = 0.78) and pseudarthrosis (9.9% vs 7.5%, respectively, p = 0.57) were seen between the groups at the last follow-up.

CONCLUSIONS Complication rates vary for the prepsoas and transpsoas approaches owing to the variable retroperitoneal anatomy encountered during surgical dissection. While the risks of a lasting motor deficit and transient sensory dis- turbances are higher for the transpsoas approach, there is a reciprocal reduction in the risks of major vascular injury and sympathetic nerve injury. These results can facilitate informed decision-making and tailored surgical planning regarding the choice of minimally invasive anterolateral access to the spine.

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