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OBJECTIVE To assess the comparative effectiveness and potential harms of cervical ripening in the outpatient compared with the inpatient setting, or different methods of ripening in the outpatient setting alone. DATA SOURCES Searches for articles in English included MEDLINE, EMBASE, CINAHL, Cochrane Library, ClinicalTrials.gov, and reference lists (up to August 2020). METHODS OF STUDY SELECTION Using predefined criteria and DistillerSR software, 10,853 citations were dual-reviewed for randomized controlled trials (RCTs) and cohort studies of outpatient cervical ripening using prostaglandins and mechanical methods in pregnant women at or beyond 37 weeks of gestation. TABULATION, INTEGRATION, AND RESULTS Using prespecified criteria, study data abstraction and risk of bias assessment were conducted by two reviewers, random-effects meta-analyses were conducted and strength of evidence was assessed. We included 30 RCTs and 10 cohort studies (N=9,618) most generalizable to women aged 25-30 years with low-risk pregnancies. All findings were low or insufficient strength of evidence and not statistically significant. Incidence of cesarean delivery was not different for any comparison of inpatient and outpatient settings, or comparisons of different methods in the outpatient setting (most evidence available for single-balloon catheters and dinoprostone). Harms were inconsistently reported or inadequately defined. Differences were not found for neonatal infection (eg, sepsis) with outpatient compared with inpatient dinoprostone, birth trauma (eg, cephalohematoma) with outpatient compared with inpatient single-balloon catheter, shoulder dystocia with outpatient dinoprostone compared with placebo, maternal infection (eg, chorioamnionitis) with outpatient compared with inpatient single-balloon catheters or outpatient prostaglandins compared with placebo, and postpartum hemorrhage with outpatient catheter compared with inpatient dinoprostone. Evidence on misoprostol, hygroscopic dilators, and other outcomes (eg, perinatal mortality and time to vaginal birth) was insufficient. CONCLUSION In women with low-risk pregnancies, outpatient cervical ripening with dinoprostone or single-balloon catheters did not increase cesarean deliveries. Although there were no clear differences in harms when comparing outpatient with inpatient cervical ripening, the certainty of evidence is low or insufficient to draw definitive conclusions. SYSTEMATIC REVIEW REGISTRATION PROSPERO, CRD42020167406.

Study Design: Systematic review. Objectives: To systematically review, critically appraise and synthesize evidence on use of stem cells from autologous stem cells from bone marrow aspirate, adipose, or any other autologous sources for fusion in the cervical spine compared with other graft materials. Methods: A systematic search of PubMed/MEDLINE was conducted for literature published through October 31, 2018 and through February 20, 2020 for EMBASE and ClinicalTrials.gov comparing autologous cell sources for cervical spine fusion to other graft options. Results: From 36 potentially relevant citations identified, 10 studies on cervical fusion met the inclusion criteria set a priori. Two retrospective cohort studies, one comparing cancellous bone marrow (CBM) versus hydroxyapatite (HA) and the other bone marrow aspirate (BMA) combined with autograft and HA versus autograft and HA alone, were identified. No statistical differences were seen between groups in either study for improvement in function, symptoms, or fusion; however, in the study evaluating BMA, the authors reported a statistically greater fusion rate and probability of fusion over time in the BMA versus the non-BMA group. Across case series evaluating BMA, authors reported improved function and pain and fusion ranged from 84% to 100% across the studies. In general, complications were poorly reported. Conclusions: The overall quality (strength) of evidence of effectiveness and safety of autologous BMA for cervical arthrodesis in the current available literature was very low. Based on currently available data, firm conclusions regarding the effectiveness or safety of BMA in cervical fusions cannot be made.

Study Design: A systematic cross-sectional survey of systematic reviews (SRs). Objective: To evaluate the methodological quality of spine surgery SRs published in 2018 using the updated AMSTAR 2 critical appraisal instrument. Methods: We identified the PubMed indexed journals devoted to spine surgery research in 2018. All SRs of spine surgical interventions from those journals were critically appraised for quality independently by 2 reviewers using the AMSTAR 2 instrument. We calculated the percentage of SRs achieving a positive response for each AMSTAR 2 domain item and assessed the levels of confidence in the results of each SR. Results: We identified 28 SRs from 4 journals that met our criteria for inclusion. Only 49.5% of the AMSTAR 2 domain items satisfied the AMSTAR 2 criteria. Critical domain items were satisfied less often (39.1%) compared with noncritical domain items (57.3%). Domain items most poorly reported include accounting for individual study risk of bias when interpreting results (14%), list and justification of excluded articles (18%), and an a priori establishment of methods prior to the review or registered protocol (18%). The overall confidence in the results was rated “low” in 2 SRs and “critically low” in 26. Conclusions: The credibility of a SR and its value to clinicians and policy makers are dependent on its methodological quality. This appraisal found significant methodological limitations in several critical domains, such that the confidence in the findings of these reviews is “critically low.”

Objectives. Although the health benefits of physical activity are well described for the general population, less is known about the benefits and harms of physical activity in people dependent upon, partially dependent upon, or at risk for needing a wheelchair. This systematic review summarizes the evidence for physical activity in people with multiple sclerosis, cerebral palsy, and spinal cord injury regardless of current use or nonuse of a wheelchair. Data sources. We searched MEDLINE®, CINAHL®, PsycINFO®, Cochrane CENTRAL, Embase®, and Rehabilitation and Sports Medicine Source from 2008 through November 2020, reference lists, and clinical trial registries. Review methods. Predefined criteria were used to select randomized controlled trials, quasiexperimental nonrandomized trials, and cohort studies that addressed the benefits and harms of observed physical activity (at least 10 sessions on 10 different days of movement using more energy than rest) in participants with multiple sclerosis, cerebral palsy, and spinal cord injury. Individual study quality (risk of bias) and the strength of bodies of evidence for key outcomes were assessed using prespecified methods. Dual review procedures were used. Effects were analyzed by etiology of impairment and physical activity modality, such as treadmill, aquatic exercises, and yoga, using qualitative, and when appropriate, quantitative synthesis using random effects meta-analyses. Results. We included 146 randomized controlled trials, 15 quasiexperimental nonrandomized trials, and 7 cohort studies (168 studies in 197 publications). More studies enrolled participants with multiple sclerosis (44%) than other conditions, followed by cerebral palsy (38%) and spinal cord injury (18%). Most studies were rated fair quality (moderate risk of bias). The majority of the evidence was rated low strength. • In participants with multiple sclerosis, walking ability may be improved with treadmill training and multimodal exercise regimens that include strength training; function may be improved with treadmill training, balance exercises, and motion gaming; balance is likely improved with postural control exercises (which may also reduce risk of falls) and may be improved with aquatic exercises, robot-assisted gait training, treadmill training, motion gaming, and multimodal exercises; activities of daily living may be improved with aquatic therapy; sleep may be improved with aerobic exercises; aerobic fitness may be improved with multimodal exercises; and female sexual function may be improved with aquatic exercise. • In participants with cerebral palsy, balance may be improved with hippotherapy and motion gaming, and function may be improved with cycling, treadmill training, and hippotherapy. • In participants with spinal cord injury, evidence suggested that activities of daily living may be improved with robot-assisted gait training. • When randomized controlled trials were pooled across types of exercise, physical activity interventions were found to improve walking in multiple sclerosis and likely improve balance and depression in multiple sclerosis. Physical activity may improve function and aerobic fitness in people with cerebral palsy or spinal cord injury. When studies of populations with multiple sclerosis and cerebral palsy were combined, evidence indicated dance may improve function. • Evidence on long-term health outcomes was not found for any analysis groups. For intermediate outcomes such as blood pressure, lipid profile, and blood glucose, there was insufficient evidence from which to draw conclusions. There was inadequate reporting of adverse events in many trials. Conclusions. Physical activity was associated with improvements in walking ability, general function, balance (including fall risk), depression, sleep, activities of daily living, female sexual function, and aerobic capacity, depending on population enrolled and type of exercise utilized. No studies reported long-term cardiovascular or metabolic disease health outcomes. Future trials could alter these findings; further research is needed to examine health outcomes, and to understand the magnitude and clinical importance of benefits seen in intermediate outcomes.

Objectives Although the health benefits of physical activity are well described for the general population, less is known about the benefits and harms of physical activity in people dependent upon, partially dependent upon, or at risk for needing a wheelchair. This systematic review summarizes the evidence for physical activity in people with multiple sclerosis, cerebral palsy, and spinal cord injury regardless of current use or nonuse of a wheelchair. Data sources We searched MEDLINE®, CINAHL®, PsycINFO®, Cochrane CENTRAL, Embase®, and Rehabilitation and Sports Medicine Source from 2008 through November 2020, reference lists, and clinical trial registries. Review methods Predefined criteria were used to select randomized controlled trials, quasiexperimental nonrandomized trials, and cohort studies that addressed the benefits and harms of observed physical activity (at least 10 sessions on 10 different days of movement using more energy than rest) in participants with multiple sclerosis, cerebral palsy, and spinal cord injury. Individual study quality (risk of bias) and the strength of bodies of evidence for key outcomes were assessed using prespecified methods. Dual review procedures were used. Effects were analyzed by etiology of impairment and physical activity modality, such as treadmill, aquatic exercises, and yoga, using qualitative, and when appropriate, quantitative synthesis using random effects meta-analyses. Results We included 146 randomized controlled trials, 15 quasiexperimental nonrandomized trials, and 7 cohort studies (168 studies in 197 publications). More studies enrolled participants with multiple sclerosis (44%) than other conditions, followed by cerebral palsy (38%) and spinal cord injury (18%). Most studies were rated fair quality (moderate risk of bias). The majority of the evidence was rated low strength. In participants with multiple sclerosis, walking ability may be improved with treadmill training and multimodal exercise regimens that include strength training; function may be improved with treadmill training, balance exercises, and motion gaming; balance is likely improved with postural control exercises (which may also reduce risk of falls) and may be improved with aquatic exercises, robot-assisted gait training, treadmill training, motion gaming, and multimodal exercises; activities of daily living may be improved with aquatic therapy; sleep may be improved with aerobic exercises; aerobic fitness may be improved with multimodal exercises; and female sexual function may be improved with aquatic exercise. In participants with cerebral palsy, balance may be improved with hippotherapy and motion gaming, and function may be improved with cycling, treadmill training, and hippotherapy. In participants with spinal cord injury, evidence suggested that activities of daily living may be improved with robot-assisted gait training. When randomized controlled trials were pooled across types of exercise, physical activity interventions were found to improve walking in multiple sclerosis and likely improve balance and depression in multiple sclerosis. Physical activity may improve function and aerobic fitness in people with cerebral palsy or spinal cord injury. When studies of populations with multiple sclerosis and cerebral palsy were combined, evidence indicated dance may improve function. Evidence on long-term health outcomes was not found for any analysis groups. For intermediate outcomes such as blood pressure, lipid profile, and blood glucose, there was insufficient evidence from which to draw conclusions. There was inadequate reporting of adverse events in many trials. Conclusions Physical activity was associated with improvements in walking ability, general function, balance (including fall risk), depression, sleep, activities of daily living, female sexual function, and aerobic capacity, depending on population enrolled and type of exercise utilized. No studies reported long-term cardiovascular or metabolic disease health outcomes. Future trials could alter these findings; further research is needed to examine health outcomes, and to understand the magnitude and clinical importance of benefits seen in intermediate outcomes.

To assess the comparative effectiveness and potential harms of cervical ripening in the outpatient compared with the inpatient setting, or different methods of ripening in the outpatient setting alone.Searches for articles in English included MEDLINE, EMBASE, CINAHL, Cochrane Library, ClinicalTrials.gov, and reference lists (up to August 2020).Using predefined criteria and DistillerSR software, 10,853 citations were dual-reviewed for randomized controlled trials (RCTs) and cohort studies of outpatient cervical ripening using prostaglandins and mechanical methods in pregnant women at or beyond 37 weeks of gestation.Using prespecified criteria, study data abstraction and risk of bias assessment were conducted by two reviewers, random-effects meta-analyses were conducted and strength of evidence was assessed. We included 30 RCTs and 10 cohort studies (N=9,618) most generalizable to women aged 25-30 years with low-risk pregnancies. All findings were low or insufficient strength of evidence and not statistically significant. Incidence of cesarean delivery was not different for any comparison of inpatient and outpatient settings, or comparisons of different methods in the outpatient setting (most evidence available for single-balloon catheters and dinoprostone). Harms were inconsistently reported or inadequately defined. Differences were not found for neonatal infection (eg, sepsis) with outpatient compared with inpatient dinoprostone, birth trauma (eg, cephalohematoma) with outpatient compared with inpatient single-balloon catheter, shoulder dystocia with outpatient dinoprostone compared with placebo, maternal infection (eg, chorioamnionitis) with outpatient compared with inpatient single-balloon catheters or outpatient prostaglandins compared with placebo, and postpartum hemorrhage with outpatient catheter compared with inpatient dinoprostone. Evidence on misoprostol, hygroscopic dilators, and other outcomes (eg, perinatal mortality and time to vaginal birth) was insufficient.In women with low-risk pregnancies, outpatient cervical ripening with dinoprostone or single-balloon catheters did not increase cesarean deliveries. Although there were no clear differences in harms when comparing outpatient with inpatient cervical ripening, the certainty of evidence is low or insufficient to draw definitive conclusions.PROSPERO, CRD42020167406.

Study design: Systematic review. Objectives: To systematically review, critically appraise and synthesize evidence on use of autologous stem cells sources for fusion in the lumbar spine. Methods: A systematic search of PubMed/MEDLINE, EMBASE and ClinicalTrials.gov through February 20, 2020 was conducted comparing autologous cell grafts to other biologics for lumbar spine fusion. The focus was on studies comparing distinct patient groups. Results: From 343 potentially relevant citations, 15 studies met the inclusion criteria set a priori. Seven studies compared distinct patient groups, with BMA being used in combination with allograft or autograft not as a standalone material. No economic evaluations were identified. Most observational studies were at moderately high risk of bias. When used for primary lumbar fusion, no statistical differences in outcomes or complications were seen between BMA+autograft/or +allograft compared to autograft/allograft alone. Compared with allograft, data from a RCT suggested statistically better fusion and lower complication rates with concentrated BMA+allograft. When used in revisions, no differences in outcomes were seen between BMA+allograft and either autograft or rh-BMP-2 but fusion rates were lower with BMA+allograft, leading to additional revision surgery. Conclusions: There was substantial heterogeneity across studies in patient populations, sample size, biologic combinations, and surgical characteristics making direct comparisons difficult. The overall quality of evidence for fusion rates and the safety of BMA in lumbar fusion procedures was considered very low, with studies being at moderately high or high risk of bias.

Study Design: Systematic review. Objectives: The primary objective of this systematic review was to define the change in impairment, disability, and pain following surgical intervention in patients with degenerative cervical myelopathy (DCM). Secondary objectives included to assess the impact of preoperative disease severity and duration of symptoms on outcomes and to summarize complications associated with surgery. Methods: A systematic literature search was conducted to identify prospective studies evaluating the effectiveness and safety of operative treatment in patients with DCM. Outcomes of interest were functional status, disability, pain, and complications. The quality of each study was evaluated using the Newcastle-Ottawa Scale, and the strength of the overall body of evidence was rated using guidelines outlined by the Grading of Recommendation Assessment, Development and Evaluation (GRADE) Working Group. Results: Of the 385 retrieved citations, 32 met inclusion criteria and are summarized in this review. Based on our results, pooled standard mean differences showed a large effect for improvement in Japanese Orthopaedic Association or modified Japanese Orthopaedic Association score from baseline at short-, medium-, and long-term follow-up: 6 to 12 months (1.92; 95% confidence interval [CI] = 1.41 to 2.43), 13 to 36 months (1.40; 95% CI = 1.12 to 1.67), and ≥36 months (1.92; 95% CI = 1.14 to 2.69) (moderate evidence). Surgery also resulted in significant improvements in Nurick, Neck Disability Index, and Visual Analogue Scale scores (low to very low evidence). The cumulative incidence of complications was low (14.1%; 95% CI = 10.1% to 18.2%). Conclusion: Surgical intervention for DCM results in significant improvements in functional impairment, disability, and pain and is associated with an acceptably low rate of complications.

Study Design: Systematic review. Objective: To conduct a systematic review and synthesis of the literature to assess the comparative effectiveness, safety, and cost-effectiveness of early (≤24 hours) versus late decompression (>24 hours) in adults with acute spinal cord injury (SCI). Methods: A systematic search was conducted of Medline, EMBASE, the Cochrane Collaboration Library, and Google Scholar to identify studies published through November 6, 2014. Studies published in any language, in humans, and with an abstract were considered for inclusion. Included studies were critically appraised and the overall strength of evidence was determined using methods proposed by the Grading of Recommendation Assessment, Development and Evaluation working group. Results: The search yielded 449 potentially relevant citations. Sixteen additional primary studies were identified through other sources. Six studies met inclusion criteria. All but 2 studies were considered to have moderately high risk of bias. Across studies and injury levels, the impact of early surgical decompression (≤24 hours) on clinically important improvement in neurological status was variable. Isolated studies reported statistically significant and clinically important improvements at 6 months (cervical injury, low strength of evidence) and following discharge from inpatient rehabilitation (all levels, very low strength of evidence) but not at other time points; another study observed a statistically significant 6 point improvement in ASIA Impairment Scale (AIS) among patients with AIS B, C, or D, but not for those with AIS A (very low strength of evidence). In one study of acute central cord syndrome without instability, a clinically and statistically meaningful improvement in total motor scores was reported at 6 and 12 months in patients treated early (versus late). There were, however, no significant differences in AIS improvement between early and late surgical groups at 6- or 12-months (very low strength of evidence). One of 3 studies found a shorter length of hospital stay associated with early surgical decompression. Of 3 studies reporting on safety, no significant differences in rates of complications (including mortality, neurologic deterioration, pneumonia or pressure ulcers) were noted between early and late decompression groups. Conclusions: Results surrounding the efficacy of early versus late decompressive surgery, as well as the quality of evidence available, were variable depending on the level of SCI, timing of follow-up, and specific outcome considered. Existing evidence supports improved neurological recovery among cervical SCI patients undergoing early surgery; however, evidence regarding remaining SCI populations and clinical outcomes was inconsistent.

Srivastava RN, Agrahari AK, Singh A, Chandra T, Raj S. Effectiveness of bone marrow-derived mononuclear stem cells for neurological recovery in participants with spinal cord injury: a randomized controlled trial. Asian J Transfus Sci. 2019;13(2):120-128.

Study Design:Systematic review.Objectives:To review, critically appraise, and synthesize evidence on the use of allogenic stem cell products for spine fusion compared with other bone graft materials.Methods:Systematic searches of PubMed/MEDLINE, through October 31, 2018 and of EMBASE and ClinicalTrials.gov through April 13, 2018 were conducted for literature comparing allogenic stem cell sources for fusion in the lumbar or cervical spine with other fusion methods. In the absence of comparative studies, case series of ≥10 patients were considered.Results:From 382 potentially relevant citations identified, 6 publications on lumbar fusion and 5 on cervical fusion met the inclusion criteria. For lumbar arthrodesis, mean Oswestry Disability Index (ODI), visual analogue scale (VAS) pain score, and fusion rates were similar for anterior lumbar interbody fusion (ALIF) using allogenic multipotent adult progenitor cells (Map3) versus recombinant human bone morphogenetic protein–2 (rhBMP-2) in the one comparative lumbar study (90% vs 92%). Across case series of allogenic stem cell products, function and pain were improved relative to baseline and fusion occurred in ≥90% of patients at ≥12 months. For cervical arthrodesis across case series, stem cell products improved function and pain compared with baseline at various time frames. In a retrospective cohort study fusion rates were not statistically different for Osteocel compared with Vertigraft allograft (88% vs 95%). Fusion rates varied across time frames and intervention products in case series.Conclusions:The overall quality (strength) of evidence of effectiveness and safety of allogenic stem cells products for lumbar and cervical arthrodesis was very low, meaning that we have very little confidence that the effects seen are reflective of the true effects.

Study Design Systematic review. Clinical Questions Compared with no stimulation, does electrical stimulation promote bone fusion after lumbar spinal fusion procedures? Does the effect differ based on the type of electrical stimulation used? Methods Electronic databases and reference lists of key articles were searched up to October 15, 2013, to identify randomized controlled trials (RCTs) comparing the effect of electrical stimulation to no electrical stimulation on fusion rates after lumbar spinal fusion for the treatment of degenerative disease. Two independent reviewers assessed the strength of evidence using the Grades of Recommendation Assessment, Development and Evaluation (GRADE) criteria. Results Six RCTs met the inclusion criteria. The following types of electrical stimulation were investigated: direct current (three studies), pulsed electromagnetic field (three studies), and capacitive coupling (one study). The control groups consisted of no stimulation (two studies) or placebo (four studies). Marked heterogeneity in study populations, characteristics, and design prevented a meta-analysis. Regardless of the type of electrical stimulation used, cumulative incidences of fusion varied widely across the RCTs, ranging from 35.4 to 90.6% in the intervention groups and from 33.3 to 81.9% in the control groups across 9 to 24 months of follow-up. Similarly, when stratified by the type of electrical stimulation used, fusion outcomes from individual studies varied, leading to inconsistent and conflicting results. Conclusion Given the inconsistency in study results, possibly due to heterogeneity in study populations/characteristics and quality, we are unable to conclude that electrical stimulation results in better fusion outcomes compared with no stimulation. The overall strength of evidence for the conclusions is low.

Study Design Systematic review. Clinical Question What is the prevalence of incidental magnetic resonance imaging (MRI) findings of the spine in asymptomatic pediatric patients? Methods Electronic databases and reference lists of key articles were searched up to December 15, 2013, to identify studies reporting the incidence or prevalence of incidental findings on MRI in asymptomatic pediatric patients. Athletes or children with a known history of trauma, infection, or congenital abnormalities were excluded. Results Seven publications, one prospective cohort, and six cross-sectional studies met the inclusion criteria. The most commonly reported findings on MRI were disc-related and included degenerative disc disease (seven studies, prevalence 19.6%), disc herniation/protrusion (four studies, 2.9%), disc height/narrowed disc space (two studies, 33.7%), and endplate changes (two studies, 5.3%). Other disc-related findings, reported by one study each, included bulging disc, abnormal nucleus shape, annular tear, high intensity zone, and nerve root compression, with prevalences ranging from 4.5 to 51.6%. Spondylolisthesis and spondylolysis were reported by one study each with a prevalence of 2.3 and 0%, respectively. Other findings reported included tumors and infections (one study, 0% for both) and Scheuermann-type changes (one study, 7.7%). Conclusions The prevalence of positive MRI findings in the asymptomatic pediatric population is higher than previously assumed, particularly in regard to disc morphology, highlighting the importance of correlating the history and physical examination to the MRI findings to avoid misdiagnosis or over-treatment in the pediatric population.

Study design Systematic review. Objective To determine whether there are magnetic resonance imaging (MRI) characteristics in patients with cervical spondylotic myelopathy that affect treatment decisions or predict postsurgical outcomes or adverse events. Summary of background data Although the role of MRI in confirming the clinical diagnosis of cervical spondylotic myelopathy and directing surgical management is well established, its potential value as a prognostic tool is largely unknown. Methods A systematic search was conducted using PubMed and the Cochrane Collaboration Library for articles published between January 1, 1956, and November 20, 2012. The overall body of evidence with respect to each clinical question was determined on the basis of precepts outlined by the Grading of Recommendation Assessment, Development and Evaluation Working Group and recommendations made by the Agency for Healthcare Research and Quality. Results The initial search yielded 268 citations. Twenty publications met all inclusion criteria and were included in the review. Three of these assessed MRI predictors of clinical deterioration in the case of conservative treatment and 17 evaluated MRI anatomic or cord characteristics that could predict surgical outcome or adverse events. There is low evidence suggesting that a high signal intensity (SI) grade on T2WI is not associated with patient deterioration during conservative treatment. High SI grade on T2WI, along with compression ratio and canal diameter, was not an important predictor of outcome. There is low evidence identifying number of high SI segments on T2WI, low SI segments on T1WI, combined T1/T2 SI, and SI ratio as important negative predictors of surgical outcome. Conclusion On the basis of this review and on low-quality evidence, we have identified 3 important negative predictors of surgical outcome: number of high SI segments on T2WI, combined T1/T2 signal change, and SI ratio.EVIDENCE-BASED CLINICAL RECOMMENDATIONS: Recommendation 1 We suggest that when clinically feasible, surgeons rely on MRI to confirm the diagnosis of CSM and rely on clinical history and examination to determine progression and severity of disease. Overall strength of evidence Low. Strength of recommendation Weak. Recommendation 2 T2 signal may be a useful prognostic indicator when used in combination with low SI change on T1WI, or as a ratio comparing compressed with noncompressed segments, or as a ratio of T2 compared with T1WI. We suggest that if surgeons use MRI signal intensity to estimate the risk of a poor outcome after surgery, they use high SI change on T2WI in combination with other signal intensity parameters, and not in isolation. Overall strength of evidence Low. StrENGTH OF RECOMMENDATION: Weak.

STUDY DESIGN Literature review. OBJECTIVE To identify case series that have been confused with cervical spondylotic myelopathy (CSM) to develop a comprehensive differential diagnosis. SUMMARY OF BACKGROUND DATA Myelopathy can be caused by a number of different etiologies. In those patients with CSM, the presentation is not always clear. Distinct radiographical and clinical characteristics, which are not always obvious, aid in arriving at the correct diagnosis. METHODS A PubMed search was done to identify reports written in English describing conditions that may present in a manner similar to CSM to differentiate them from CSM. Material from review articles and relevant textbooks was also considered. Information regarding the number of patients, the specific diagnosis presenting as myelopathy, the diagnostic findings, and the method(s) for distinguishing CSM from the initial diagnosis was abstracted from included articles. Salient features of the conditions were summarized. RESULTS A total of 35 citations (totaling 474 patients) that reported on diagnoses confused with CSM based on clinical presentation were included. All were case reports or small case series. The differential diagnoses were organized into 7 categories: congenital/anatomic, degenerative, neoplastic, inflammatory/autoimmune, idiopathic, circulatory, and metabolic. The primary conditions in the differential included amyotrophic lateral sclerosis, multiple sclerosis, syringomyelia, and spinal tumors. CONCLUSION In the vast majority of cases, magnetic resonance imaging was an invaluable tool in determining the correct diagnosis. Electrodiagnostic studies, cerebrospinal fluid profile, unique symptomatology, and consideration of patient demographics can also aid in the diagnosis. Bilateral sensory complaints in the hands are suspicious for cervical cord pathology and MR imaging of the same should be done even if the electromyography/nerve conduction studies (NCS) suggest bilateral carpal tunnel syndrome. SUMMARY STATEMENTS: Physical exam findings are not always consistent with severity of disease in CSM; therefore, correlation to plain radiographs, MRI, and patient symptomatology is essential for arriving at the correct diagnosis. In some cases where these studies are still equivocal, use of other studies should be considered including electrodiagnostic studies as well as cerebrospinal fluid examination.

Study design: Systematic review. Study rationale: Disc degeneration is a common process starting early in life. Often disc herniation is an early step in disc degeneration, which may cause pain or stenosis. How quickly this subsequent disc degeneration occurs following a disc herniation and subsequent surgical treatment and whether certain spinal procedures increase the rate of degeneration remain unclear. Objectives: To investigate the risk of subsequent radiographic disc degeneration following discectomy, discography, and conservative care in patients with a first-time diagnosed herniated nucleus pulpous (HNP) and to ascertain whether this risk in these defined groups changes over time. Methods: A systematic review of pertinent articles published up to June 2012. Key articles were searched to identify studies evaluating the risk of subsequent radiographic disc degeneration following treatment for HNP. Studies that included patients undergoing secondary surgery for disc herniation or that did not use a validated classification system to measure the severity of disc degeneration were excluded. Two independent reviewers assessed the strength of evidence using the GRADE criteria and disagreements were resolved by consensus. Results: From a total of 147 possible citations, three cohort studies (class of evidence III) met our inclusion criteria and form the basis for this report. The risk of subsequent lumbar disc degeneration following standard discectomy was significantly greater compared with both microdiscectomy (48.7% vs 9.1%) and asymptomatic controls (90% vs 68%) in two studies with mean follow-ups of 5.5 and 25.3 years, respectively. Following conservative care for first-time HNP in the third study, the risk of progression of lumbar disc degeneration was 47.6% over the first 2 years of follow-up and 95.2% over the next 6 years of follow-up. In the same study, the risk of lumbar disc degeneration was shown to increase incrementally over the course of the 8-year follow-up, with all patients showing signs of degeneration at final examination. Conclusion: Standard discectomy in first-time lumbar HNP may increase the risk of subsequent same-level lumbar disc degeneration compared with microdiscectomy as seen in one low-quality study. However, disc degeneration is likely a natural, temporal consequence following HNP, as demonstrated in a second low-quality study. The overall strength of evidence for the conclusions is very low.

Study Design Systematic review. Study Rationale To seek out and assess the best quality evidence available comparing opening wedge osteotomy (OWO) and closing wedge osteotomy (CWO) in patients with ankylosing spondylitis to determine whether their results differ with regard to several different subjective and objective outcome measures. Objective The aim of this study is to determine whether there is a difference in subjective and objective outcomes when comparing CWO and OWO in patients with ankylosing spondylitis suffering from clinically significant thoracolumbar kyphosis with respect to quality-of-life assessments, complication risks, and the amount of correction of the spine achieved at follow-up. Methods A systematic review was undertaken of articles published up to July 2012. Electronic databases and reference lists of key articles were searched to identify studies comparing effectiveness and safety outcomes between adult patients with ankylosing spondylitis who received closing wedge versus opening wedge osteotomies. Studies that included pediatric patients, polysegmental osteotomies, or revision procedures were excluded. Two independent reviewers assessed the strength of evidence using the GRADE criteria and disagreements were resolved by consensus. Results From a total of 67 possible citations, 4 retrospective cohorts (class of evidence III) met our inclusion criteria and form the basis for this report. No differences in Oswestry Disability Index, visual analog scale for pain, Scoliosis Research Society (SRS)-24 score, SRS-22 score, and patient satisfaction were reported between the closing and opening wedge groups across two studies. Regarding radiological outcomes following closing versus opening osteotomies, mean change in sagittal vertical axis ranged from 8.9 to 10.8 cm and 8.0 to 10.9 cm, respectively, across three studies; mean change in lumbar lordosis ranged from 36 to 47 degrees and 19 to 41 degrees across four studies; and mean change in global kyphosis ranged from 38 to 40 degrees and 28 to 35 degrees across two studies. Across all studies, overall complication risks ranged from 0 to 16.7% following CWO and from 0 to 23.6% following OWO. Conclusion No statistically significant differences were seen in patient-reported or radiographic outcomes between CWO and OWO in any study. The risks of dural tear, neurological injury, and reoperation were similar between groups. Blood loss was greater in the closing wedge compared with the opening wedge group, while the risk of paralytic ileus was less. The overall strength of evidence for the conclusions is low.

Study design: Systematic review. Clinical question: Does single-level unconstrained, semiconstrained, or fully constrained cervical artificial disc replacement (C-ADR) improve health outcomes compared with single-level anterior cervical discectomy and fusion (ACDF) in the long-term? Methods: A systematic review was undertaken for articles published up to October 2011. Electronic databases and reference lists of key articles were searched to identify US Food and Drug Administration (FDA) studies reporting long-term (≥ 48 months) follow-up results of C-ADR compared with ACDF. Non-FDA trials and FDA trials reporting outcomes at short-term or mid-term follow-up periods were excluded. Two independent reviewers assessed the strength of evidence using the GRADE criteria and disagreements were resolved by consensus. Results: Two FDA trials reporting outcomes following C-ADR (Bryan disc, Prestige disc) versus ACDF at follow-up periods of 48 months and 60 months were found (follow-up rates are 68.7% [318/463] and 50.1% [271/541], respectively). Patients in the C-ADR group showed a higher rate of overall success, greater improvements in Neck Disability Index, neck and arm pain scores, and SF-36 PhysicalComponent Scores at long-term follow-up compared with those in the ACDF group. The rate of adjacent segment disease was less in the C-ADR group versus the ACDF group at 60 months (2.9% vs 4.9%). Normal segmental motion was maintained in the C-ADR group. Furthermore, rates of revision and supplemental fixation surgical procedures were lower in the arthroplasty group. Conclusions: C-ADR is a viable treatment option for cervical herniated disc/spondylosis with radiculopathy resulting in improved clinical outcomes, maintenance of normal segmental motion, and low rates of subsequent surgical procedures at 4 to 5 years follow-up. More studies with long-term follow-up are warranted.

Study design: Systematic review. Clinical questions: What is the effectiveness of multilevel cervical artificial disc replacement (C-ADR) compared with multilevel fusion with respect to pain and functional outcomes, and are the two procedures comparable in terms of safety? What is the effectiveness of multilevel C-ADR compared with single-level C-ADR with respect to pain and functional outcomes, and are the two procedures comparable in terms of safety? Methods: A systematic review was undertaken for articles published up to October 2011. Electronic databases and reference lists of key articles were searched to identify studies comparing multilevel C-ADR with multilevel anterior cervical discectomy and fusion (ACDF) or comparing multilevel C-ADR with single-level C-ADR. Studies which compared these procedures in the lumbar or thoracic spine or that reported alignment outcomes only were excluded. Two independent reviewers assessed the strength of evidence using the GRADE criteria and disagreements were resolved by consensus. Results: Two studies compared multilevel C-ADR with multilevel ACDF. While both reported improved Neck Disability Index (NDI) and Short-Form 36 (SF-36) scores after C-ADR compared with ACDF, only one study reported statistically significant results. Seven studies compared single-level C-ADR with multilevel C-ADR. Results were similar in terms of overall success, NDI and SF-36 scores, and patient satisfaction. There is discrepant information regarding rates of heterotopic ossification; dysphagia rate may be higher in multilevel C-ADR. Conclusions: The literature suggests that outcomes are at least similar for multilevel C-ADR and ACDF and may favor C-ADR. Future studies are necessary before firm recommendations can be made favoring one treatment strategy. Multilevel C-ADR seems to have similar results to single-level C-ADR but may have higher rates of heterotopic ossification and dysphagia.

Administrative data provide researchers with relatively inexpensive access to large numbers of patients nationwide and are increasingly being used for epidemiological, effectiveness, and safety outcomes studies. Publically available databases from sources such as the NIS and CMS provide information on large proportions of medical visits in the United States, and provide a good source of “real-world” health care data for reliably reported data. However, because administrative data are primarily gathered for billing purposes rather than research purposes, there are several limitations that must be considered, including the potential for inaccuracy and bias. As for all study types, critical appraisal of administrative database studies are critical to avoid arriving at inaccurate conclusions.

This systematic review for a clinical practice guideline by the ACP summarizes evidence about the benefits and harms of nonpharmacologic therapies, including acupuncture, exercise, tai chi, yoga, m...

Background: Lateral mass screw fixation with plates or rods has become the standard method of posterior cervical spine fixation and stabilization for a variety of surgical indications. Despite ubiquitous usage, the safety and efficacy of this technique have not yet been established sufficiently to permit “on-label” U.S. Food and Drug Administration approval for lateral mass screw fixation systems. The purpose of this study was to describe the safety profile and effectiveness of such systems when used in stabilizing the posterior cervical spine. Methods: A systematic search was conducted in MEDLINE and the Cochrane Collaboration Library for articles published from January 1, 1980, to December 1, 2011. We included all articles evaluating safety and/or clinical outcomes in adult patients undergoing posterior cervical subaxial fusion utilizing lateral mass instrumentation with plates or rods for degenerative disease (spondylosis), trauma, deformity, inflammatory disease, and revision surgery that satisfied our a priori inclusion and exclusion criteria. Results: Twenty articles (two retrospective comparative studies and eighteen case series) satisfied the inclusion and exclusion criteria and were included. Both of the comparative studies involved comparison of lateral mass screw fixation with wiring and indicated that the risk of complications was comparable between treatments (range, 0% to 7.1% compared with 0% to 6.3%, respectively). In one study, the fusion rate reported in the screw fixation group (100%) was similar to that in the wiring group (97%). Complication risks following lateral mass screw fixation were low across the eighteen case series. Nerve root injury attributed to screw placement occurred in 1.0% (95% confidence interval, 0.3% to 1.6%) of patients. No cases of vertebral artery injury were reported. Instrumentation complications such as screw or rod pullout, screw or plate breakage, and screw loosening occurred in

Study Design. Systematic review. Objective. To answer the following 3 clinical questions: (1) What is the evidence supporting a heritable predisposition for cervical spondylotic myelopathy (CSM) and ossification of the posterior longitudinal ligament (OPLL)? (2) What specific genetic polymorphisms have been associated with CSM and OPLL? (3) What is the evidence supporting a genetic basis for predicting postoperative outcomes for patients with CSM and OPLL? Summary of Background Data. OPLL and CSM are thought to be multifactorial conditions resulting from a combination of environmental and genetic factors. Methods. A systematic review of the English language literature was undertaken for articles published between 1980 and November 7, 2012. The strength of evidence was determined by 2 independent reviewers using the Grading of Recommendation Assessment, Development and Evaluation (GRADE) criteria for studies addressing the first question of heritability and using the criteria set forth by the HuGENet Working Group in the Venice Interim Guidelines to address the last 2 questions of genetic association. Results. Of the 118 citations identified through the initial literature search, a total of 23 articles remained after application of inclusion/exclusion criteria. The 3 family association studies related to question 1 supported the principle of an inherited predisposition to CSM and OPLL; however, the strength of evidence supporting these findings was low. Within the 19 case-control studies related to question 2, 2 single nucleotide polymorphisms (COL6A1/Intron 32(−29) and COL11A2/Intron 6(−4)) were observed at higher frequencies in OPLL cases than in controls in more than 1 study and may be associated with its development. There was insufficient evidence to support an association between CSM and any specific single nucleotide polymorphism or haplotype or to support the association of specific gene alleles with postoperative CSM outcomes. Conclusion. Existing family studies provide support for the principle of an inherited predisposition to CSM and OPLL. Multiple studies support the association of 2 collagen gene related single nucleotide polymorphisms with OPLL; however, there is insufficient evidence to support the association between CSM and any genetic polymorphism or to support a genetic predictor of surgical outcome. Conclusion. Summary Statements. Conclusion. Statement 1: Existing family studies provide support for the principle of an inherited predisposition to CSM and OPLL. Conclusion. Statement 2: Two SNPs related to the collagen 6A1 gene (COL6A1/Intron 32(−29)) and the collagen 11A2 gene (COL11A2/Intron 6(−4)) have been associated with OPLL in multiple studies and may be associated with its development. Conclusion. Statement 3: No statement can be made from the literature regarding the association of specific SNPs or haplotypes with CSM. Conclusion. Statement 4: No statement can be made from the literature regarding genetic predictors of surgical outcome in the context of OPLL or CSM.

IntroductionThe primary objective of this work was to define the neurological benefit conferred by surgical intervention to patients with degenerative cervical myelopathy (DCM). Secondary objective...

Study design Systematic review. Objective We performed a systematic review to determine the risk and to define potential identifiable risk factors for the development of adjacent segment pathology (ASP) after cervical fusion surgery. Summary of background data During the past several decades, the indications for spinal arthrodesis have expanded, with a dramatic increase in the rate of cervical spine fusion in the United States during the past decade. However, as more of these procedures are performed over time, there have been concerns regarding the potential for these patients to develop changes at levels adjacent to the index procedure. Questions remain whether the development of clinical ASP (CASP) are iatrogenic in nature or part of natural history. Methods A systematic review of the literature was undertaken for articles published in English language between 1990 and March 15, 2012. Electronic databases and reference lists of key articles were searched to identify articles reporting risk factors for CASP after cervical fusion. Two independent reviewers assessed the level of evidence and the overall quality of the literature using the Grades of Recommendation Assessment, Development, and Evaluation criteria. Disagreements were resolved by consensus. Results We identified 5 studies (4 retrospective cohorts, 1 database study) from our search strategy that met the inclusion criteria from a total of 176 possible studies for review. The prevalence of CASP ranged from 11% to 12% at 5 years, 16% to 38% at 10 years, and 33% at 17 years. Factors that may contribute to the development of CASP include age less than 60 years, fusing adjacent to the C5-C6 and/or C6-C7 levels, a pre-existing disc herniation, and/or dural compression secondary to spinal stenosis with a mean anteroposterior diameter spinal canal of 13 mm or smaller. Conclusion CASP remains a controversial topic despite multiple attempts of elucidating an iatrogenic effect of spinal fusion versus the natural history of spinal degeneration. The mean rate of the development of symptomatic degeneration in the cervical spine after arthrodesis is estimated between 1.6% and 4.2% per year. The mean rate of reoperation for CASP is estimated at 0.8% per year. In addition, fusing adjacent to but not including the C5-C6 and/or C6-C7 disc spaces seems to consistently increase the risk of developing CASP. Consensus statement 1. The risk of developing new symptoms secondary to adjacent segment pathology causing radiculopathy and/or myelopathy after cervical fusion surgery ranges from a cumulative rate of 1.6% to 4.2% per year. Strength of Statement: Strong. 2. The risk of developing adjacent-level symptoms may be increased if disc protrusion, disc degeneration, or cord effacement is present at C5–C6 and/or C6–C7 and if those levels are adjacent to the planned surgical level. Strength of Statement: Strong.

Study design Systematic review. Objective To determine the population risk of radiographical degeneration in the lumbar and cervical spine as well as the risk of adjacent segment pathology (ASP) among patients who receive and do not receive (but were eligible for) fusion for lumbar or cervical degeneration. Summary of background data The etiology of ASP remains unclear. It has been suggested that ASP results because of a biomechanical stress transfer from the fusion. It has also been suggested that ASP is a continuation of natural arthritic disease. We sought to examine the literature and compare the rates of spinal degeneration without fusion and the rates of adjacent segment degeneration. Similarities or differences may yield insight into the etiology of ASP. Methods A systematic review of the English language literature was undertaken for articles published between 1990 and March 15, 2012. Electronic databases and reference lists of key articles were searched to identify articles reporting prevalence and/or incidence of radiographical spinal degeneration (de novo degeneration) or radiographical adjacent segment pathology (RASP) (degeneration after fusion). Two independent reviewers assessed the level of evidence and the overall quality of the literature using the Grades of Recommendation Assessment, Development and Evaluation criteria. Disagreements were resolved by consensus. Results We identified 15 studies from our search strategy that met the inclusion criteria from a total of 235 possible studies. Various definitions of radiographical spinal degeneration were used across the studies. For the population risk of radiographical lumbar and cervical spine degeneration, the cumulative incidence ranged from 12.7% to 51.5% during a 5- to 25-year period across 3 studies. One study of the cervical spine reported that there was a baseline prevalence of disc degeneration of 21.7% and, in their follow-up study, reported that 47.9% of individuals had evidence of progression of degeneration during a mean 5.8-year follow-up. The rate of progression per 100 person-years showed an age- and sex-specific trend, with females progressing at a faster rate than males through the 50s, males progressing faster than females during the 60s and 70s, with rates becoming identical in the 80s. Regarding age-specific risk, the prevalence of lumbar degeneration increased with age across 2 studies. For RASP following fusion, the cumulative incidence ranged from 6.3% to 44.4% during 6 to 12.6 years of follow-up across the 7 studies; the risk of cervical RASP was higher than that of lumbar despite the shorter mean follow-up periods. Conclusion RASP may occur at a higher rate than natural history and suggests that another factor (such as biomechanical effect of fusion) may accelerate pathologic changes. Consensus statement ASP may occur at a higher rate than natural spinal degeneration and suggests that another factor (such as biomechanical effect of fusion) may accelerate pathologic changes. Strength of Statement: Weak.