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Background: Both shoulder surgeons and patients who are considering total shoulder arthroplasty are interested in the anticipated improvement in shoulder comfort and function after the procedure. The purpose of the present study was to characterize shoulder-specific functional gains in relation to preoperative shoulder function and to present this information in a way that can be easily communicated to patients who are considering this surgery.Methods: We analyzed the preoperative and follow-up shoulder function in patients managed with total shoulder arthroplasty for the treatment of primary glenohumeral osteoarthritis. Functional self-assessments were available for 102 (80%) of 128 shoulders after thirty to sixty months of follow-up. Outcome was assessed with respect to the change in the number of shoulder functions that were performable, the change in shoulder function as a percentage of the preoperative functional deficit, and the change in the ability to perform specific shoulder functions.Results: The average number of shoulder functions that were performable improved from four of twelve preoperatively to nine of twelve postoperatively (p < 0.01). Function improved in ninety-six shoulders (94%). The number of functions that were performable at the time of follow-up was positively associated with preoperative shoulder function (p < 0.05): the better the preoperative function, the better the follow-up function. The improvement in function was greatest for shoulders with less preoperative function (p < 0.01). On the average, patients regained approximately two-thirds of the functions that had been absent preoperatively. Significant improvement was noted in eleven of the twelve shoulder functions that were examined (p < 0.01). The chance of regaining a function that had been absent before surgery was 73%, whereas the chance of losing a function that had been present before surgery was 6%. Older men tended to have greater functional improvement than younger men.Conclusion: Total shoulder arthroplasty for the treatment of primary glenohumeral osteoarthritis significantly improves shoulder function. Postoperative function is related to preoperative function. The improvement that was observed in this clinical series can be conveyed to patients most simply by stating that, after surgery, shoulders typically regained approximately two-thirds of the functions that had been absent preoperatively. [ABSTRACT FROM AUTHOR]

Study Design: Retrospective cohort study of prospectively accrued data., Objective: To evaluate a large, prospective, multicentre dataset of surgically treated degenerative cervical myelopathy (DCM) cases on the contemporary risk of C5 palsy with surgical approach., Summary of Background Data: The influence of surgical technique on postoperative C5 palsy after decompression for DCM is intensely debated. Comprehensive, covariate-adjusted analyses are needed using contemporary data., Methods: Patients with moderate to severe DCM were prospectively enrolled in the multicenter, randomized, Phase III CSM-Protect clinical trial and underwent either anterior or posterior decompression between Jan 31, 2012 and May 16, 2017. The primary outcome was the incidence of postoperative C5 palsy, defined as the onset of muscle weakness by at least one grade in manual muscle test at the C5 myotome with slight or absent sensory disruption after cervical surgery. Two comparative cohorts were made based on the anterior or posterior surgical approach. Multivariate hierarchical mixed-effects logistic regression was used to estimate odds ratios (OR) with 95% confidence intervals (CI) for C5 palsy., Results: A total of 283 patients were included, and 53.4% underwent posterior decompression. The total incidence of postoperative C5 palsy was 7.4% and was significantly higher in patients who underwent posterior decompression compared with anterior decompression (11.26% vs. 3.03%, P =0.008). After multivariable regression, the posterior approach was independently associated with greater than four times the likelihood of postoperative C5 palsy ( P =0.017). Rates of C5 palsy recovery were comparable between the two surgical approaches., Conclusion: The odds of postoperative C5 palsy are significantly higher after posterior decompression compared to anterior decompression for DCM. This may influence surgical decision-making when there is equipoise in deciding between anterior and posterior treatment options for DCM., Level of Evidence: Therapeutic Level-II., Competing Interests: The authors report no conflicts of interest., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Study Design: A prospective observational international study., Objective: The aim of this study was to evaluate outcomes of decompressive surgery in patients with very severe degenerative cervical myelopathy (DCM)., Summary of Background Data: Although decompressive surgery has been evidenced as a safe and effective approach for patients with myelopathic deficiencies, studies have suggested residual disability following treatment in patients with more severe disease presentation., Methods: Postoperative outcomes of 60 patients with very severe DCM (modified Japanese Orthopaedic Association [mJOA] score ≤8) were compared to outcomes of 188 patients with severe DCM (mJOA 9-11). Postimputation follow-up rate was 93.1%. Unadjusted and adjusted analyses were performed using two-way repeated measures of covariance., Results: The two cohorts were similar in demographics, length of duration of myelopathy symptoms, source of stenosis, and surgical approaches used to decompress the spine. The very severe and severe cohorts differed in preoperative Nurick grades (4.97 vs. 3.91, respectively, P < 0.0001) and Neck Disability Index scores (45.20 vs. 56.21, respectively, P = 0.0006). There were no differences in Short Form 36 (SF-36v2) physical (PCS) and mental (MCS) component summary scores. Both cohorts improved in mJOA, Nurick, Neck Disability Index, and SF-36v2 PCS and MCS scores. Despite the substantial postoperative improvements, patients in both cohorts had considerable residual symptoms. Two-thirds of the patients in the very severe cohort had severe (mJOA ≤11) or moderate (mJOA ≤ 14) myelopathy symptoms at 24 months follow-up. Longer duration of disease was associated with poorer treatment response., Conclusion: Decompressive surgery is effective in patients with very severe DCM; however, patients have significant residual symptoms and disability. The very severe subgroup (mJOA ≤8) of patients with DCM represents a distinct group of patients and their different clinical trajectory is important for clinicians and patients to recognize. Duration of symptoms negatively affects chances for recovery. Whenever possible, patients with DCM should be treated before developing very severe symptomatology., Level of Evidence: 2.

Study Design: Analysis of a combined prospective dataset., Objective: To compare clinical outcomes in patients with and without preexisting depression or bipolar disorder undergoing surgery for degenerative cervical myelopathy (DCM)., Summary of Background Data: Psychiatric comorbidities, including depression, have been associated with worse clinical outcomes after lumbar spine surgery; however, it is unclear whether these psychiatric disorders are also predictive of outcomes in patients undergoing surgery for the treatment of DCM., Methods: Four hundred and one patients with symptomatic DCM were enrolled in the prospective AOSpine International or North America study at twelve North American sites. Patients were evaluated preoperatively and at 6, 12, and 24 months using the modified Japanese Orthopedic Association scale (mJOA), Nurick score, Neck Disability Index (NDI), and Short- Form 36v2 (SF-36v2) Health Survey. A mixed model analytic approach was used to evaluate differences in outcomes at 24 months among patients with and without psychiatric disorders, while controlling for relevant baseline characteristics and surgical factors., Results: Ninety-seven patients (24.19%) were diagnosed with preexisting depression or bipolar disorder. There were more females (65.98%) with these psychiatric disorders than males (34.02%) (P < 0.0001). Patients with psychiatric comorbidities were more likely to have cardiovascular (P = 0.0177), respiratory (P < 0.0001), gastrointestinal (P < 0.0001), rheumatologic (P = 0.0109), and neurologic (P = 0.0309) disorders. At 24 months after surgery, patients in both groups demonstrated significant improvements on the mJOA, Nurick, NDI, and SF-36v2 Physical Component Score (PCS). Patients with depression or bipolar disorder, however, did not exhibit a significant or clinically important change on the SF-36v2 Mental Component Score (MCS). There were no differences in mJOA and Nurick scores at 24 months among patients in each group. Improvement in NDI, SF-36v2 PCS, and MCS, however, were smaller in patients with depression or bipolar disorder than those without., Conclusion: Patients with depression or bipolar disorder have smaller functional and quality of life improvements after surgery compared to patients without psychiatric comorbidities., Level of Evidence: 2.

Study Design: A prospective multicenter cohort study., Objective: The aim of this study was to compare outcomes of surgery for the treatment for degenerative cervical myelopathy (DCM) between Caucasians and East Asians., Summary of Background Data: Numerous studies have indicated that race can influence both disease prevalence and clinical prognosis in a variety of medical conditions; however, none have evaluated the impact of race on surgical outcomes in patients with DCM., Methods: Four hundred and seventy-nine patients with symptomatic DCM were enrolled in the prospective AOSpine CSM-International study at 16 global sites. Preoperatively, and at each follow-up, patients were evaluated using the modified Japanese Orthopedic Association scale (mJOA), the Nurick score, the Neck Disability Index (NDI), and the Short- Form 36 (SF-36) Health Survey. A mixed-model analytic approach was used to evaluate differences in outcomes between races at 24 months postoperatively, while controlling for relevant baseline characteristics and surgical factors., Results: Three hundred and twenty-four (67.64%) patients were Caucasian and 106 (22.13%) were East Asian. There was no difference in the incidence of ossification of the posterior longitudinal ligament (OPLL) between the two races; however a greater percentage of Caucasians in India (46.15%) and Turkey (41.38%) displayed evidence of OPLL than Caucasians in other regions (P < 0.001). The frequency of spondylosis was significantly higher in Caucasians (P < 0.001). Caucasians had a longer duration of symptoms (27.33 ± 34.47 months) than East Asians (23.11 ± 35.68 months) (P < 0.001), and a lower preoperative score on the SF-36 Physical Component Score (33.85 ± 9.04) than East Asians (37.47 ± 8.67) (P < 0.001). At 24 months after surgery, there were no differences in functional status or QOL between East Asians and Caucasians, after adjusting for baseline characteristics, surgical preferences, and disease causation. Rates of perioperative complications were not significantly different between the races (P = 0.261)., Conclusion: Decompressive surgery for DCM results in comparable functional gains and is equally safe in Caucasians and East Asians., Level of Evidence: 2.

Study Design: A prospective, randomized, controlled, parallel, single-blinded noninferiority multicenter pivotal FDA IDE trial., Objective: The objective of this study was to investigate efficacy and safety of i-Factor Bone Graft (i-Factor) compared with local autograft in single-level anterior cervical discectomy and fusion (ACDF) for cervical radiculopathy., Summary of Background Data: i-Factor is a composite bone substitute material consisting of the P-15 synthetic collagen fragment adsorbed onto anorganic bone mineral and suspended in an inert biocompatible hydrogel carrier. P-15 has demonstrated bone healing efficacy in dental, orthopedic, and nonhuman applications., Methods: Patients randomly received either autograft (N = 154) or i-Factor (N = 165) in a cortical ring allograft. Study success was defined as noninferiority in fusion, Neck Disability Index (NDI), and Neurological Success endpoints, and similar adverse events profile at 12 months., Results: At 12 months (follow-up rate 87%), both i-Factor and autograft subjects demonstrated a high fusion rate (88.97% and 85.82%, respectively, noninferiority P = 0.0004), significant improvements in NDI (28.75 and 27.40, respectively, noninferiority P < 0.0001), and high Neurological Success rate (93.71% and 93.01%, respectively, noninferiority P < 0.0001). There was no difference in the rate of adverse events (83.64% and 82.47% in the i-Factor and autograft groups, respectively, P = 0.8814). Overall success rate consisting of fusion, NDI, Neurological Success and Safety Success was higher in i-Factor subjects than in autograft subjects (68.75% and 56.94%, respectively, P = 0.0382). Improvements in VAS pain and SF-36v2 scores were clinically relevant and similar between the groups. A high proportion of patients reported good or excellent Odom outcomes (81.4% in both groups)., Conclusion: i-Factor has met all four FDA mandated noninferiority success criteria and has demonstrated safety and efficacy in single-level ACDF for cervical radiculopathy. i-Factor and autograft groups demonstrated significant postsurgical improvement and high fusion rates., Level of Evidence: 1.

Study Design: Retrospective review of a prospective database., Objective: To describe a novel method that uses baseline normalization and area under the curve (AUC) to compare surgical outcomes between patients surgically treated anteriorly versus posteriorly for cervical spondylotic myelopathy (CSM)., Summary and Background Data: It is important to control for baseline characteristics, especially disease severity, when evaluating differences in outcomes between 2 treatment groups. However, current methods of reporting outcomes are limited perhaps diminish the health impact of the entire postoperative recovery experience., Methods: In the prospective, multicenter AO Spine North America CSM database, 147 patients had complete modified Japanese Orthopaedic Association (mJOA) data at baseline and at 6-, 12-, and 24-months postoperatively and were either treated anteriorly (n = 94) or posteriorly (n = 53). Each patient's follow-up mJOA scores were normalized by dividing them by the patient's baseline value. A graph was then plotted with the time point on the x-axis and the normalized score or "recovery index" on the y-axis. The AUC was calculated and then compared between the anterior and posterior surgical approach groups., Results: The non-normalized recovery profile of the anterior group was better than that of the posterior group, as the patients treated anteriorly had less functional impairment at baseline. After normalization, patients in the anterior and posterior group had similar recovery indices and AUCs at 6-months following surgery. At 24-months, patients treated posteriorly had a significantly higher recovery index (1.32) and a larger AUC (16.3) than those treated anteriorly (1.11, 14.5, P = 0.004 and P = 0.006, respectively)., Conclusion: This is the first study to apply AUC analysis to patients with CSM. In surgical patients with CSM, those treated anteriorly achieved a higher mJOA score at all time points than those treated posteriorly. The recovery indices, however, were not significantly different between approach groups at 6 months., Level of Evidence: 3.

Study Design: Analysis of the prospective AOSpine CSM-International and North America datasets and survey of AO Spine International., Objective: This study aims to define the minimum clinically important difference (MCID) of the modified Japanese Orthopaedic Association (mJOA) in patients with degenerative cervical myelopathy (DCM)., Summary of Background Data: The mJOA is the most frequently used clinician-administered tool to assess functional status in patients with DCM. By defining its MCID, clinicians can better evaluate treatment outcomes for this condition., Methods: Three methods were used to determine the MCID of the mJOA: (1) distribution-based, (2) anchor-based and receiver operating characteristic (ROC) analysis, and (3) professional opinion. Distribution-based methods were used to estimate the MCID by computing the half standard deviation and standard error of measurement. Using anchor-based methods, mJOA at 12 months after surgery was compared between patients who were "slightly improved" on the Neck Disability Index (NDI) and those who were "unchanged." ROC analysis was performed to compute a discrete integer value for the MCID that yielded the smallest difference between sensitivity and specificity. We repeated anchor-based methods for patients with mild (mJOA: 15-17), moderate (mJOA: 12-14), and severe disease (mJOA <12)., Results: The half standard deviation of the baseline mJOA was 1.36 and the standard error of measurement was 1.21. The difference in mJOA between patients who "slightly improved" on the NDI and "unchanged" patients was 1.11. ROC analysis yielded a value of 2 for the MCID. The survey of 416 spine professionals confirmed these estimates: the mean response was 1.65 ± 0.66. The MCID significantly varied depending on myelopathy severity: ROC analysis yielded a threshold of 1 for mild, 2 for moderate, and 3 for severe patients., Conclusion: The MCID of the mJOA is estimated to be between 1 and 2 points and varies with myelopathy severity. This knowledge will enable clinicians to identify meaningful functional improvements in DCM patients., Level of Evidence: N/A.

Study Design: Prospective, multicenter international cohort., Objective: To evaluate outcomes of surgical decompression for cervical spondylotic myelopathy (CSM) at a global level., Summary of Background Data: CSM is a degenerative spine disease and the most common cause of spinal cord dysfunction worldwide. Surgery is increasingly recommended as the preferred treatment strategy for CSM to improve neurological and functional status and quality of life. The outcomes of surgical intervention for CSM have never been evaluated at an international level., Methods: Between October 2007 and January 2011, 479 symptomatic patients with image evidence of CSM were enrolled in the prospective, multicenter AOSpine CSM-International study from 16 global sites. Preoperative and postoperative clinical status, functional impairment, and quality of life were evaluated using the modified Japanese Orthopaedic Assessment Scale, Nurick Scale, Neck Disability Index, and Short-Form-36v2. Preoperative and 12- and 24-month postoperative outcomes were compared using mixed-model analysis of covariance for repeated measurements., Results: The study cohort consisted of 310 males and 169 females, with a mean age of 56.37 ± 11.91 years. There were significant differences in age, etiology, and surgical approaches between the regions. At 24 months postoperatively, the mean modified Japanese Orthopaedic Assessment Scale score improved from 12.50 (95% confidence interval [CI], 12.24-12.76) to 14.90 (95% CI, 14.64-15.16); the Neck Disability Index improved from 36.38 (95% CI, 34.33-38.43) to 23.20 (95% CI, 21.24-25.15); and the SF36v2 Physical Component Score and Mental Composite Score improved from 34.28 (95% CI, 33.46-35.10) to 40.76 (95% CI, 39.71-41.81) and 39.45 (95% CI, 38.25-40.64) to 46.24 (95% CI, 44.94-47.55), respectively. The rate of neurological complications was 3.13%., Conclusion: Surgical decompression for CSM is safe and results in improved functional status and quality of life in patients around the world, irrespective of differences in medical systems and sociocultural determinants of health., Level of Evidence: 3.

Study Design: Prospective study., Objective: This study aims to determine the psychometric properties of the modified Japanese Orthopaedic Association (mJOA) scale., Summary of Background Data: Several outcome measures assess functional impairment and quality of life in patients with cervical myelopathy. However, a "gold standard" has not been established. One of the most widely accepted tools for assessing functional status is the mJOA scale., Methods: Two hundred and seventy-seven surgical patients with cervical spondylotic myelopathy were enrolled in the prospective cervical spondylotic myelopathy-North America study. Functional status was evaluated at baseline and at 6, 12, and 24 months postoperatively. The internal consistency of the mJOA was assessed by computing a Cronbach α for the total score and after removing 1 item at a time. Convergent validity and divergent validity were measured by correlating the mJOA with other assessment tools. The responsiveness of the scale was determined by comparing mJOA scores at baseline and 12 months after surgery and computing a Cohen effect size., Results: The internal consistency of the scale was moderate with a Cronbach α of 0.63. Sphincter dysfunction measured a different dimension than the other 3 scale components. The mJOA was correlated with the Nurick score (r =-0.625) but was not associated with subscales of the Short-Form 36 that measure different constructs. These findings suggest convergent and divergent validity. The mJOA was responsive to change as reflected by a Cohen effect size of 1., Conclusion: The mJOA is a useful tool in the assessment of cervical spondylotic myelopathy and it should be adopted as the standard for evaluating functional status in this population.

Study Design: A prospective multicenter cohort study., Objective: To establish the relationship between preoperative quantitative magnetic resonance imaging (MRI) parameters and clinical presentation and postoperative outcomes in patients with cervical spondylotic myelopathy., Summary of Background Data: Correlation of magnetic resonance imaging with clinical presentation and outcomes in cervical spondylotic myelopathy is poorly understood., Methods: A total of 134 magnetic resonance imaging scans were reviewed from 12 sites across North America. The transverse area (TA) of the spinal cord at the site of maximal compression was computed, and spinal cord signal intensity (SI) changes on T1-/T2-weighted imaging (WI) were evaluated. Detailed clinical assessments--neurological signs, symptoms, Nurick grade, modified Japanese Orthopaedic Association, segmental-tract score, and long-tract score of modified Japanese Orthopaedic Association, 30-m walk test, Short-Form 36 questionnaire, and neck disability index were performed at admission, 6 months, and 12 months postoperatively., Results: The total number of neurological signs in a patient correlated with TA (P = 0.01) and SI changes on T1-/T2WI (P = 0.05). Pre- and postoperative Nurick grade (P = 0.03, P = 0.02), modified Japanese Orthopaedic Association score (P = 0.005, P = 0.001), segmental-tract score (P = 0.05, P = 0.006), and long-tract score (P = 0.006, P = 0.002), 30-m walk test (P = 0.002, P = 0.01) correlated with TA. There was no significant difference in pre- and postoperative clinical scores in patients with/without SI changes. Patients with severe cord compression showed SI changes on T1-/T2WI more frequently (r =-0.27, r =-0.38). Pyramidal signs--plantar response, Hoffmann reflex and hyper-reflexia correlated with TA (P = 0.003, P = 0.0004, P = 0.024, respectively) and SI changes on T1/T2WI (P = 0.02)., Conclusion: TA closely mirrors the clinical presentation of cervical spondylotic myelopathy and may be used in predicting surgical outcomes. Pyramidal signs correlated with TA and/or SI changes on T1-/T2WI. The total number of neurological signs in a patient correlated with TA. There was no significant relationship between TA, age and duration of symptoms., Level of Evidence: 3.

Study Design: A prospective observational multicenter study., Objective: To help solve the debate regarding whether the anterior or posterior surgical approach is optimal for patients with cervical spondylotic myelopathy (CSM)., Summary of Background Data: The optimal surgical approach to treat CSM remains debated with varying opinions favoring anterior versus posterior surgical approaches. We present an analysis of a prospective observational multicenter study examining outcomes of surgical treatment for CSM., Methods: A total of 278 subjects from 12 sites in North America received anterior/posterior or combined surgery at the discretion of the surgeon. This study focused on subjects who had either anterior or posterior surgery (n = 264, follow-up rate, 87%). Outcome measures included the modified Japanese Orthopedic Assessment scale, the Nurick scale, the Neck Disability Index, and the Short-Form 36 (SF-36) Health Survey version 2 Physical and Mental Component Scores., Results: One hundred and sixty-nine patients were treated anteriorly and 95 underwent posterior surgery. Anterior surgical cases were younger and had less severe myelopathy as assessed by mJOA and Nurick scores. There were no baseline differences in Neck Disability Index or SF-36 between the anterior and posterior cases. Improvement in the mJOA was significantly lower in the anterior group than posterior group (2.47 vs. 3.62, respectively, P < 0.01), although the groups started at different levels of baseline impairment. The extent of improvement in the Nurick Scale, Neck Disability Index, SF-36 version 2 Physical Component Score, and SF-36 version 2 Mental Component Score did not differ between the groups., Conclusion: Patients with CSM show significant improvements in several health-related outcome measures with either anterior or posterior surgery. Importantly, patients treated with anterior techniques were younger, with less severe impairment and more focal pathology. We demonstrate for the first time that, when patient and disease factors are controlled for, anterior and posterior surgical techniques have equivalent efficacy in the treatment of CSM., Level of Evidence: 3.

Study Design: Subgroup analysis of a prospective multicenter study., Objective: Outcome analysis of nonoperatively treated elderly patients with type II odontoid fractures, including assessment of consequence of a fracture nonunion., Summary of Background Data: Odontoid fractures are among the most common fractures in the elderly, and controversy exists regarding treatment., Methods: Subgroup analysis of a prospective multicenter study of elderly patients (≥65 yr) with type II odontoid fracture. Neck Disability Index and Short-Form 36 (SF-36) version 2 were collected at baseline and 6 and 12 months. Fifty-eight (36.5%) of the 159 patients were treated nonoperatively., Results: Of the 58 patients initially treated nonoperatively, 8 died within 90 days and were excluded. Of the remaining 50 patients, 11 (22.0%) developed nonunion, with 7 (63.6%) requiring surgery. Four of the 39 (10.3%) patients classified as having "successful union" required surgery due to late fracture displacement. Thus, 15 (30.0%) patients developed primary or secondary nonunion and 11 (22.0%) required surgery. The overall 12-month mortality was 14.0% (nonunion = 2, union = 5; P= 0.6407). For union and nonunion groups, Neck Disability Index and SF-36 version 2 declined significantly at 12 months compared with preinjury values (P< 0.05), except for SF-36 version 2 Physical Functioning (P= 0.1370). There were no significant differences in outcome parameters based on union status at 12 months (P> 0.05); however, it is important to emphasize that the 12-month outcomes for the nonunion patients reflect the status of the patient after delayed surgical treatment in the majority of these cases., Conclusion: Nonoperative treatment for type II odontoid fracture in the elderly has high rates of nonunion and mortality. Patients with nonunion did not report worse outcomes compared with those who achieved union at 12 months; however, the majority of patients with nonunion required delayed surgical treatment. These findings may prove useful for patients who are not surgical candidates or elect for nonoperative treatment., Level of Evidence: 2.

Study Design: Descriptive article and narrative review., Objective: To explain the rationale and design of the cervical spondylotic myelopathy (CSM)-Protect clinical trial that aims to elucidate the efficacy and safety of riluzole in the context of CSM., Summary of Background Data: CSM is the most common cause of spinal cord-related dysfunction internationally. Although surgery is effective in preventing the progression of impairment, and in some cases improving functional outcomes, many patients continue to exhibit significant disability in the postoperative setting. Evidence from preclinical studies suggests that glutamate-related excitotoxicity may contribute to the pathology of CSM and that administration of the sodium and glutamate-blocking medication riluzole, when combined with spinal cord decompression, may mitigate this effect and improve neurobehavioral outcomes. Although riluzole is FDA approved and has been shown to be safe and effective in the context of amyotrophic lateral sclerosis, its efficacy and safety in the context of CSM remain unknown., Methods: Descriptive article with narrative review of the literature., Results: In addition to providing pertinent preclinical background on the topic, this descriptive article and narrative review discusses the design and current status of an ongoing phase III randomized controlled trial evaluating the efficacy and safety of riluzole, combined with surgical decompression, in the treatment of CSM., Conclusion: On the basis of current projections, we estimate that the interim analysis for this study will take place in the spring of 2014, at which time an adaptive sample size adjustment may take place.

Study Design: Retrospective, multicenter cohort study., Objective: Assess for differences in short- and long-term mortality between operative and nonoperative treatment for elderly patients with type II odontoid fractures., Summary of Background Data: There is controversy regarding whether operative or nonoperative management is the best treatment for elderly patients with type II odontoid fractures., Methods: This is a retrospective study of consecutive patients aged 65 years or older with type II odontoid fracture from 3 level I trauma centers from 2003-2009. Demographics, comorbidities, and treatment were abstracted from medical records. Mortality outcomes were obtained from medical records and a public database. Hazard ratios (HRs) and 95% confidence intervals (CI) were calculated., Results: A total of 322 patients were included (mean age, 81.8 yr; range, 65.0-101.5 yr). Compared with patients treated nonoperatively (n = 157), patients treated operatively (n = 165) were slightly younger (80.4 vs. 83.2 yr, P = 0.0014), had a longer hospital (15.0 vs. 7.4 d, P < 0.001) and intensive care unit (1.5 vs. 1.1 d, P = 0.008) stay, and were more likely to receive a feeding tube (18% vs. 5%, P = 0.0003). Operative and nonoperative treatment groups had similar sex distribution (P = 0.94) and Charlson comorbidity index (P = 0.11). Within 30 days of presentation, 14% of patients died, and at maximal follow-up (average = 2.05 yr; range = 0 d-7.02 yr), 44% had died. On multivariate analysis, nonoperative treatment was associated with higher 30-day mortality (HR = 3.00, 95% CI = 1.51-5.94, P = 0.0017), after adjusting for age (HR = 1.10, 95% CI = 1.05-1.14; P < 0.0001), male sex (P = 0.69), and Charlson comorbidity index (P = 0.16). At maximal follow-up, there was a trend toward higher mortality associated with nonoperative treatment (HR = 1.35, 95% CI = 0.97-1.89, P = 0.079), after adjusting for age (HR = 1.07, 95% CI = 1.05-1.10; P < 0.0001), male sex (HR = 1.55, 95% CI = 1.10-2.16; P = 0.012), and Charlson comorbidity index (HR = 1.28, 95% CI = 1.16-1.40; P < 0.0001)., Conclusion: Surgical treatment of type II odontoid fracture in this elderly population did not negatively impact survival, even after adjusting for age, sex, and comorbidities. The data suggest a significant 30-day survival advantage and a trend toward improved longer-term survival for operatively treated over nonoperatively treated patients., Level of Evidence: 4.

Study Design: Multicenter prospective cohort study., Objective: To identify patient and treatment characteristics associated with treatment success or failure in the management of odontoid fractures., Summary of Background Data: Odontoid fractures are the most common cervical spine fractures in the elderly and represent a significant management challenge with widely divergent views regarding operative versus nonoperative management., Methods: A total of 159 patients 65 years and older with radiographically confirmed type II odontoid fractures were enrolled at 10 sites in the United States and 1 site in Canada between January 2006 and May 2009. Subjects were followed at 6 and 12 months post-initial treatment with Neck Disability Index and SF-36v2 scores. Final treatment outcome was classified as failure or success. Treatment failure was defined as death by any cause, decline in Neck Disability Index by more than 9.5 absolute points, or occurrence of a major treatment-related complication. Baseline characteristics between the groups were compared using t test for the continuous variables and χ2 test for the categorical variables. Baseline characteristics associated with treatment outcomes were identified by multiple logistic stepwise regression analysis., Results: A total of 101 (63.5%) patients were treated surgically and 58 (36.5%) conservatively. Forty-four (27.7%) patients had a successful outcome and 86 (54.1%) had a treatment failure; for 29 patients (18.2%), treatment status could not be determined (3 withdrew; 26 were lost to follow-up). Twenty-nine (18.2%) patients expired before the 12-month follow-up. Follow-up information was available for 103 of 127 surviving (81.1%) patients. Twelve-month SF-36v2 scores were worse in the failure group. The characteristics associated with treatment failure were older age (odds ratio [OR] = 1.08 for each year of age); initial nonsurgical treatment (OR = 3.09); male sex (OR = 4.33), and baseline neurological system comorbidity (OR = 4.13)., Conclusion: Older age, initial nonsurgical treatment, and male sex are associated with failure of treatment in patients with geriatric odontoid fractures.

Study Design: A retrospective cohort study of operative versus nonoperative treatment of isolated type II odontoid fractures in patients aged 80 years and more without neurologic deficit admitted to a level 1 spinal cord injury center between June 1985 and July 2006., Objective: To assess the presentation and acute complications of operatively and nonoperatively managed type II odontoid fractures in the octogenarian population., Summary of Background Data: Type II odontoid fractures are the most common cervical spine fracture in the elderly. Studies suggest acute in-hospital complication rates in type II odontoid fractures in the elderly exceed 50%. Few studies have examined the acute in-hospital outcomes of isolated type II odontoid fractures in the octogenarian population., Methods: The medical records of 223 consecutive C2 fractures from June 1985 to July 2006 over the age of 80 years were reviewed retrospectively. Patients with associated cervical spine fractures were excluded. Eighty neurologically intact patients over age 80 were identified with isolated acute type II odontoid fractures. The charts were reviewed and mechanism of injury, comorbidities, date of injury, date of admission, date of discharge, radiology reports, discharge disposition, associated injuries, fracture management, type of surgical fixation (if any), and documented complications were abstracted., Results: Thirty-two patients received operative treatment (10 anterior and 22 posterior) and 40 patients received nonsurgical treatment. Eight patients were excluded because the medical record could not be located. The mean age was 85.5+/-3.5 years in the surgical and 87.3+/-4.7 years in the nonsurgical group (P>0.05); mean length of acute hospital stay was 11.2+/-8.5 days in the nonsurgical and 22.8+/-28.3 days in the surgical group (P<0.05); mean comorbidity score was 2.3+/-1.2 in the nonsurgical and 2.0+/-1.0 in the surgical group (P>0.5); mean fracture displacement was 4.1+/-3.5 mm in the nonsurgical and 3.9+/-3.4 mm in the surgical group (P>0.5). Acute in-hospital mortality rate was 15% in the nonsurgical group and 12.5% in the surgical group (P>0.05). The percentage of patients experiencing at least one significant complication was higher in the operative group than the nonoperative group (62% vs. 35%, respectively, P<0.05)., Conclusions: Type II odontoid fractures in the octogenarian population are associated with substantial morbidity and mortality, irrespective of management method. Prospective studies are needed to better elucidate management strategies for this difficult clinical problem.