Neurological recovery after early versus delayed surgical decompression for acute traumatic spinal cord injury.

The aim of this study was to determine whether early surgical treatment results in better neurological recovery 12 months after injury than late surgical treatment in patients with acute traumatic spinal cord injury (tSCI). Patients with tSCI requiring surgical spinal decompression presenting to 17 centres in Europe were recruited. Depending on the timing of decompression, patients were divided into early (≤ 12 hours after injury) and late (> 12 hours and < 14 days after injury) groups. The American Spinal Injury Association neurological (ASIA) examination was performed at baseline (after injury but before decompression) and at 12 months. The primary endpoint was the change in Lower Extremity Motor Score (LEMS) from baseline to 12 months. The final analyses comprised 159 patients in the early and 135 in the late group. Patients in the early group had significantly more severe neurological impairment before surgical treatment. For unadjusted complete-case analysis, mean change in LEMS was 15.6 (95% confidence interval (CI) 12.1 to 19.0) in the early and 11.3 (95% CI 8.3 to 14.3) in the late group, with a mean between-group difference of 4.3 (95% CI -0.3 to 8.8). Using multiply imputed data adjusting for baseline LEMS, baseline ASIA Impairment Scale (AIS), and propensity score, the mean between-group difference in the change in LEMS decreased to 2.2 (95% CI -1.5 to 5.9). Compared to late surgical decompression, early surgical decompression following acute tSCI did not result in statistically significant or clinically meaningful neurological improvements 12 months after injury. These results, however, do not impact the well-established need for acute, non-surgical tSCI management. This is the first study to highlight that a combination of baseline imbalances, ceiling effects, and loss to follow-up rates may yield an overestimate of the effect of early surgical decompression in unadjusted analyses, which underpins the importance of adjusted statistical analyses in acute tSCI research.

Design recommendations for exoskeletons: Perspectives of individuals with spinal cord injury.

OBJECTIVE: This study investigated the expectations of individuals with spinal cord injury (SCI) regarding exoskeletons. DESIGN: The survey consisted out of questions regarding multiple aspects of exoskeleton technology. SETTING: An online survey was distributed via the monthly newsletter of the Dutch Patient Association for Spinal Cord Injury (SCI). PARTICIPANTS: Individuals with SCI who are members of the Dutch Patient Association for SCI. OUTCOME MEASURES: General impression of exoskeleton technology, expectations regarding capabilities and user-friendliness, training expectations and experiences, future perspectives and points of improvement. RESULTS: The survey was filled out by 95 individuals with SCI, exoskeletons were considered positive and desirable by 74.7%. About 11 percent (10.5%) thought one could ambulate faster, or just as fast, while wearing an exoskeleton as able-bodied people. Furthermore, 18.9% expected not to use a wheelchair or walking aids while ambulating with the exoskeleton. Twenty-five percent believed that exoskeletons could replace wheelchairs. Some main points of improvement included being able to wear the exoskeleton in a wheelchair and while driving a car, not needing crutches while ambulating, and being able to put the exoskeleton on by oneself. CONCLUSION: Individuals with SCI considered exoskeletons as a positive and desirable innovation. But based on the findings from the surveys, major points of improvement are necessary for exoskeletons to replace wheelchairs in the future. For future exoskeleton development, we recommend involvement of individuals with SCI to meet user expectations and improve in functionality, usability and quality of exoskeletons.

Orthopedic Interventions for Foot Deformities in Non-Ambulant People with Duchenne Muscular Dystrophy: A Retrospective Study on Indications, Post-Operative and Long-Term Outcomes.

BACKGROUND: Progressive equinovarus deformities are common in people with Duchenne Muscular Dystrophy (DMD); they may provoke pain, pressure spots, cause problems with wearing footwear, and may lead to an unstable sitting position. OBJECTIVE: Explore indications and compare complications and long-term outcomes after soft tissue and osseous interventions in people with DMD. METHODS: Retrospective, monocenter, longitudinal study. Data on indications, equinus and varus deformity before and after surgery, wound healing problems, 'pain', edema, and long-term outcomes were collected from medical files. Soft tissue interventions were compared with osseous interventions. RESULTS: From a series of 18 patients, data on 32 surgical interventions and 169 follow-up visits were analyzed. 'Footrest placement' was the most frequent surgical indication, followed by pain. Osseous interventions were performed in older patients with rigid deformities. Directly after surgery remaining deformities were reported after soft tissue interventions (18 %), no remaining deformities were reported after osseous interventions. Pain and edema were frequently present, especially after osseous surgery. Longitudinal follow-up showed that surgical interventions could lead to a neutral foot for a for more than 3 years on average years. Relapses of foot deformity occurred, especially the recurrence of varus deformity after osseous interventions. CONCLUSIONS: Surgical interventions can successfully lead to a neutral foot position for for more than 3 years on average. Soft tissue interventions appear to be superior to osseous corrections, considering the varus recurrence period and complications, and may be considered when feet are still (partly) correctable. Pain management and edema prevention should be anticipated before surgery. Future research on patient reported outcomes as well as evaluating the outcome of the initial indication is needed to further identify benefits.

Reliability, validity and responsiveness of the Dutch version of the AOSpine PROST (Patient Reported Outcome Spine Trauma).

PURPOSE: To validate the Dutch version of AOSpine PROST (Patient Reported Outcome Spine Trauma). METHODS: Patients were recruited from two level-1 trauma centers from the Netherlands. Next to the AOSpine PROST, patients also filled out SF-36 for concurrent validity. Descriptive statistics were used to analyze the characteristics. Content validity was assessed by evaluating the number of inapplicable or missing questions. Also floor and ceiling effects were analyzed. Internal consistency was assessed by calculating Cronbach's α and item-total correlation coefficients (itcc). Spearman correlation tests were performed within AOSpine PROST items and in correlation with SF-36. Test-retest reliability was analyzed using Intraclass Correlation Coefficients (ICC). Responsiveness was assessed by calculating effect sizes (ES) and standardized response mean (SRM). Factor analysis was performed to explore any dimensions within AOSpine PROST. RESULTS: Out of 179 enrolled patients, 163 (91.1%) were included. Good results were obtained for content validity. No floor or ceiling effects were seen. Internal consistency was excellent (Cronbach's α = 0.96, itcc 0.50-0.86), with also good Spearman correlations (0.25-0.79). Compared to SF-36, the strongest correlation was seen for physical functioning (0.79; p < .001). Also test-retest reliability was excellent (ICC = 0.92). Concerning responsiveness analysis, very good results were seen with ES = 1.81 and SRM = 2.03 (p < 0.001). Factor analysis revealed two possible dimensions (Eigenvalues > 1), explaining 65.4% of variance. CONCLUSIONS: Very satisfactory results were obtained for reliability, validity and responsiveness of the Dutch version of AOSpine PROST. Treating surgeons are encouraged to use this novel and validated tool in clinical setting and research to contribute to evidence-based and patient-centered care.

Clinical relevance of occipital condyle fractures.

CONTEXT: No consensus about classification, treatment, and clinical relevance of occipital condyle fractures (OCFs) exists. AIMS: The aim of the study was to determine radiological, clinical, and functional outcome of OCFs and thereby determine its clinical relevance. SETTINGS AND DESIGN: This was a retrospective analysis of a prospective follow-up study. MATERIALS AND METHODS: From May 2005 to May 2008, all OCFs were included from a Level-1 trauma center. Patient files were reviewed for patient and fracture characteristics. Fracture classification was done according to the Anderson criteria. Clinical outcome was assessed by completing two questionnaires, radiological outcome by computed tomography imaging, and functional outcome by measuring active cervical range of motion using a Cybex EDI-320. STATISTICAL ANALYSIS USED: A Fisher's exact Test was used in categorical variables and a one-sample t-test for comparing means of active cervical range of motion in occipital fracture patients with normal values. An independent samples t-test was carried out to compare the means of groups with and without accompanying cervical fractures for each motion. RESULTS: Thirty-nine patients were included (4 type I, 16 type II, and 19 type III). Twenty-seven patients completed follow-up, of whom 26 were treated conservatively. Fracture healing was established in 25 of 28 fractures at a median follow-up of 19 months. Eleven patients had none to minimal pain or disability at follow-up, 12 had mild, and two had moderate pain or disability on questionnaires. No statistically significant difference in active cervical range of motion was identified comparing means stratified for accompanying cervical fractures. CONCLUSIONS: Conservatively treated patients with an OCF generally show favorable radiological and clinical outcome.

Recovery after traumatic thoracic- and lumbar spinal cord injury: the neurological level of injury matters.

STUDY DESIGN: Multicenter prospective cohort. OBJECTIVE: To discern neurological- and functional recovery in patients with a traumatic thoracic spinal cord injury (TSCI), conus medullaris syndrome (CMS), and cauda equina syndrome (CES). SETTING: Specialized spinal cord injury centers in Europe. METHOD: Lower extremity motor score (LEMS) and spinal cord independent measure (SCIM) scores from patients with traumatic TSCI, CMS, and CES were extracted from the EMSCI database. Scores from admittance and during rehabilitation at 1, 3, 6, and 12 months were compared. Linear mixed models were used to statistically analyse differences in outcome, which were corrected for the ASIA Impairment Scale (AIS) in the acute phase. RESULTS: Data from 1573 individuals were analysed. Except for the LEMS in patients with a CES AIS A, LEMS, and SCIM significantly improved over time for patients with a TSCI, CMS, and CES. Irrespectively of the AIS score, recovery in 12 months after trauma as measured by the LEMS showed a statistically significant difference between patients with a TSCI, CMS, and CES. Analysis of SCIM score showed no difference between patients with TSCI, CMS, or CES. CONCLUSION: Difference in recovery between patients with a traumatic paraplegia is based on neurological (motor) recovery. Regardless the ceiling effect in CES patients, patients with a mixed upper and lower motor neuron syndrome (CMS) showed a better recovery compared with patients with a upper motor neuron syndrome (TSCI). These findings enable stratifications of patients with paraplegia according to the level and severity of SCI.

[Dysphagia caused by osteophytes of the cervical spine]. / Dysfagie door osteofyten van de cervicale wervelkolom.

BACKGROUND: Diffuse idiopathic skeletal hyperostosis (DISH) is a systemic condition characterised by ossification of the ligaments around the spinal column due to unknown aetiology. This is often asymptomatic, but it can cause dysphagia in rare cases. CASE DESCRIPTION: A 64-year-old man was referred to the ENT department with progressive dysphagia symptoms he had had for years. Extensive analysis by the ENT specialist did not reveal any abnormalities of the swallowing motor functions. However, osteophytes of the cervical spine of the patient were visible in the X-ray of the cervical spine. The patient was referred to an orthopaedic surgeon. The osteophytes were surgically removed from the cervical spine using a ventral approach. Immediately after the surgery, the patient no longer had problems swallowing. CONCLUSION: In rare cases, dysphagia can be caused by osteophytes of the cervical spine in patients with DISH. Surgical removal of these osteophytes usually has good results.

Neurological recovery after traumatic spinal cord injury: what is meaningful? A patients' and physicians' perspective.

STUDY DESIGN: Cross-sectional survey. OBJECTIVES: Most studies on neurological recovery after traumatic spinal cord injury (tSCI) assess treatment effects using the American Spinal Injury Association Impairment Scale (AIS grade) or motor points recovery. To what extent neurological recovery is considered clinically meaningful is unknown. This study investigated the perceived clinical benefit of various degrees of neurological recovery one year after C5 AIS-A tSCI. SETTING: The Netherlands. METHODS: By means of a web-based survey SCI patients and physicians evaluated the benefit of various scenarios of neurological recovery on a scale from 0 to 100% (0% no benefit to 100% major benefit). Recovery to AIS-C and D, was split into C/C+ and D/D+, which was defined by the lower and upper limit of recovery for each grade. RESULTS: A total of 79 patients and 77 physicians participated in the survey. Each AIS grade improvement from AIS-A was considered significant benefit (all p < 0.05), ranging from 47.8% (SD 26.1) for AIS-B to 86.8% (SD 24.3) for AIS-D+. Motor level lowering was also considered significant benefit (p < 0.05), ranging from 66.1% (SD 22.3) for C6 to 81.7% (SD 26.0) for C8. CONCLUSIONS: Meaningful recovery can be achieved without improving in AIS grade, since the recovery of functional motor levels appears to be as important as improving in AIS grade by both patients and physicians. Moreover, minor neurological improvements within AIS-C and D are also considered clinically meaningful. Future studies should incorporate more detailed neurological outcomes to prevent potential underestimation of neurological recovery by only using the AIS grade.

Highest ambulatory speed using Lokomat gait training for individuals with a motor-complete spinal cord injury: a clinical pilot study.

BACKGROUND: Motor impairment and loss of ambulatory function are major consequences of a spinal cord injury (SCI). Exoskeletons are robotic devices that allow SCI patients with limited ambulatory function to walk. The mean walking speed of SCI patients using an exoskeleton is low: 0.26 m/s. Moreover, literature shows that a minimum speed of 0.59 m/s is required to replace wheelchairs in the community. OBJECTIVE: To investigate the highest ambulatory speed for SCI patients in a Lokomat. METHODS: This clinical pilot study took place in the Rehabilitation Center Kladruby, in Kladruby (Czech Republic). Six persons with motor-complete sub-acute SCI were recruited. Measurements were taken at baseline and directly after a 30 min Lokomat training. The highest achieved walking speed, vital parameters (respiratory frequency, heart rate, and blood pressure), visual analog scale for pain, and modified Ashworth scale for spasticity were recorded for each person. RESULTS: The highest reached walking speed in the Lokomat was on average 0.63 m/s (SD 0.03 m/s). No negative effects on the vital parameters, pain, or spasticity were observed. A significant decrease in pain after the Lokomat training was observed: 95% CI [0.336, 1.664] (p = 0.012). CONCLUSION: This study shows that it is possible for motor-complete SCI individuals to ambulate faster on a Lokomat (on average 0.63 m/s) than what is currently possible with over-ground exoskeletons. No negative effects were observed while ambulating on a Lokomat. Further research investigating walking speed in exoskeletons after SCI is recommended.

Pathogenesis of Idiopathic Ventral Herniation of Spinal Cord: Neuropathologic Analysis.

BACKGROUND: Idiopathic ventral herniation of the spinal cord is rarely seen as a cause of gradually increasing neurologic deficit. Its cause has never been clarified. It could be the result of a developmental disorder at 30- to 60-day gestational age. Neuropathologic analysis of herniated spinal cord tissue could probably support this hypothesis. CASE DESCRIPTION: In a patient suffering from idiopathic ventral herniation of the spinal cord, a biopsy was performed in order to reduce the space-occupying effect. The biopsy was taken while intraoperative neuromonitoring was used. The patient recovered uneventfully without any additional deficit. Tissue analysis included histopathologic, immunohistochemical, and molecular examination (methylation profiling). The tissue did not appear as a normally functioning spinal cord; instead, a non-neoplastic glio-(neuronal) proliferation was found. CONCLUSION: These findings support a developmental disorder as a cause for idiopathic ventral spinal cord herniation.

Discontinuous ventilator weaning of patients with acute SCI.

STUDY DESIGN: Retrospective, single centre cohort study. OBJECTIVES: To determine factors associated with ventilator weaning success and failure in patients with acute spinal cord injury (SCI); determine length of time and attempts required to wean from the ventilator successfully and determine the incidence of pneumonia. SETTING: BG Klinikum Hamburg, Level 1 trauma centre, SCI Department, Germany. METHODS: From 2010 until 2017, 165 consecutive patients with cervical SCI, initially dependent on a ventilator, were included and weaned discontinuously via tracheal cannula. Data related to anthropometric details, neurological injury, respiratory outcomes, and weaning parameters were prospectively recorded in a database and retrospectively analysed. RESULTS: Seventy-nine percent of all patients were successfully weaned from ventilation. Average duration of the complete weaning process was 37 days. Ninety-one percent of the successfully weaned patients completed this on first attempt. Age (>56 years), level of injury (C4 and/or above), vital capacity (<1500 ml), obesity (>25 kg/m2), and chronic obstructive pulmonary disease (COPD) significantly decreased the chance of successful weaning. These factors also correlated with a higher number of weaning attempts. High level of injury, older age, and reduced vital capacity also increased the duration of the weaning process. Patients with low vital capacity and concurrent therapy with Baclofen and Dantrolene showed higher rates of pneumonia. CONCLUSIONS: We conclude that mentioned factors are associated with weaning outcome and useful for clinical recommendations and patient counselling. These data further support the complexity of ventilator weaning in the SCI population due to associated complications, therefore we recommend conducting weaning of patients with SCI on intensive or intermediate care units (ICU/IMCU) in specialised centres.

The diagnostic value of 18F-FDG-PET/CT and MRI in suspected vertebral osteomyelitis - a prospective study.

PURPOSE: The aim of this study was to determine the diagnostic value of 18F-fluorodeoxyglucose (FDG) positron emission tomography and computed tomography (PET/CT) and magnetic resonance imaging (MRI) in diagnosing vertebral osteomyelitis. METHODS: From November 2015 until December 2016, 32 patients with suspected vertebral osteomyelitis were prospectively included. All patients underwent both 18F-FDG-PET/CT and MRI within 48 h. All images were independently reevaluated by two radiologists and two nuclear medicine physicians who were blinded to each others' image interpretation. 18F-FDG-PET/CT and MRI were compared to the clinical diagnosis according to international guidelines. RESULTS: For 18F-FDG-PET/CT, sensitivity, specificity, PPV, and NPV in diagnosing vertebral osteomyelitis were 100%, 83.3%, 90.9%, and 100%, respectively. For MRI, sensitivity, specificity, PPV, and NPV were 100%, 91.7%, 95.2%, and 100%, respectively. MRI detected more epidural/spinal abscesses. An important advantage of 18F-FDG-PET/CT is the detection of metastatic infection (16 patients, 50.0%). CONCLUSION: 18F-FDG-PET/CT and MRI are both necessary techniques in diagnosing vertebral osteomyelitis. An important advantage of 18F-FDG-PET/CT is the visualization of metastatic infection, especially in patients with bacteremia. MRI is more sensitive in detection of small epidural abscesses.

Symptomatic Adjacent Segment Disease After Anterior Cervical Discectomy for Single-level Degenerative Disk Disease.

STUDY DESIGN: A prospective cohort of 142 patients underwent either anterior cervical discectomy alone, anterior cervical discectomy with fusion by cage stand-alone, or anterior cervical discectomy with arthroplasty. We then followed up on their condition for a mean of 9.1±1.9 years (5.6-12.2 y) later. OBJECTIVE: We aimed to evaluate the annual rate of clinically symptomatic adjacent segment disease (ASD) and to analyze predictive factors. SUMMARY OF BACKGROUND DATA: Until recent, ASD has been predominantly evaluated radiologically. It is not known whether all patients had complaints. A frequent cited annual rate of ASD is 2.9%, but a growing number of studies report a lower annual rate. Furthermore, maintaining motion to prevent ASD is one reason for implanting a cervical disk prosthesis. However, the results of studies contradict one another. METHODS: Participants took part in a randomized controlled trial that ended prematurely because of the publication of evidence that did not justify continuation of the trial. The patients were randomly allocated to 3 groups, each of which received one of the abovementioned treatments. We defined symptomatic ASD as signs and symptoms caused by degeneration of an intervertebral disk adjacent to a level of previous anterior cervical disk surgery. At the last follow-up, we were able to ascertain whether clinically symptomatic ASD was present in any of the participants. RESULTS: The overall annual rate of symptomatic ASD was 0.7%. We found no statistically significant correlations between any of the investigated factors and symptomatic ASD except for the surgical method used. Symptomatic ASD was seen less often in anterior cervical discectomy solely or anterior cervical discectomy with arthroplasty than in anterior cervical discectomy with fusion by plate fixation. CONCLUSIONS: The annual rate of symptomatic ASD after an anterior cervical discectomy procedure was estimated to be 0.7%. This seems to be related to the procedure, although firm conclusions cannot be drawn. LEVEL OF EVIDENCE: Level 2-prospective cohort.

Substantial clinical benefit for Neck Disability Index revisited: establishing the goal for treatment?

PURPOSE: It is difficult for clinicians to inform patients about the success rate of a treatment as a cervical anterior discectomy procedure. Ideally, a proportion of good outcome as rated by patients is known. Patient-reported outcome measurements are helpful. The purpose is to relate the difference in Neck Disability Index (NDI) after a cervical anterior discectomy procedure for single level cervical degenerative disc disease with the patients' rating of their actual clinical situation after long-term follow-up to define the substantial clinical benefit (SCB). METHODS: After completion of the NDI, patients who were surgically treated for cervical single level degenerative disease were asked to complete a five-item Likert scale to rate their clinical situation. After dichotomisation of the outcome in good versus less than good, a cut-off value was defined by determining the value of the difference of NDI with the highest specificity and sensitivity. Funding was not obtained. RESULTS: SCB for NDI after surgery for cervical single level degenerative disease should be set at ten with area under the curve (AUC) of 0.71 for sensitivity as well specificity. CONCLUSIONS: The goal for each treatment is a good outcome. While comparing treatments for cervical degenerative disc disease only those with an SCB of ten will be relevant for the patient, as patients who achieved this difference in NDI rated their actual situation at long-term follow-up as good.

The Pathogenesis of Ventral Idiopathic Herniation of the Spinal Cord: A Hypothesis Based on the Review of the Literature.

Idiopathic ventral herniation of the spinal cord (SC) is not often encountered in daily practice. Its clinical prevalence, however, will increase through increasing awareness and more frequent use of MRI. A clear explanation of its pathophysiology has never been formulated. It was hypothesized that the findings during surgery might indicate the real causative mechanism. An extensive literature search was performed, using Embase, PubMed, and Google Scholar. Titles and abstracts were screened by two investigators, using strict inclusion and exclusion criteria. Reference lists of the full paper versions of each included article were checked. The following data were registered for the articles included: age, gender, level of herniation, relation to intervertebral disk, duration of symptoms, findings from surgery, and outcomes. Nine cases treated at our department were added. A total of 117 articles reporting on 259 patients were included. Including our cases, 268 patients were reviewed. Females outnumbered males (160/100). The mean age was 51.3 ± 12.0 years. In 236 patients, the duration of symptoms was reported: 55.5 ± 55.6 months. In 178 patients, the intraoperative findings for the herniated part of the SC were not mentioned. In 59 patients, a tumor-like extrusion was seen, without any alteration to the SC. Deformation of the SC itself was never observed. Biopsies of these structures were without clinical consequence. Based on the intraoperative findings reported in literature and the cases presented, acquired causes, such as trauma and erosion of the dura due to a herniated disk, were not plausible. We hypothesize that a non-functioning appendix to the SC can only develop during an early embryologic phase, in which several layers separate. We propose renaming this entity as congenital transdural appendix of the SC.

Ten Meters Walking Speed in Spinal Cord-Injured Patients: Does Speed Predict Who Walks and Who Rolls?

BACKGROUND: Walking speed is assumed to be a key factor in regaining ambulation after spinal cord injury (SCI). However, from the literature it remains unclear which walking speed usually results in independent community ambulation. OBJECTIVE: The primary aim of this study was to determine at which walking speed SCI patients tend to walk in the community instead of using a wheelchair. The secondary aim was to investigate clinical conditions that favor independent ambulation in the community. METHODS: Data from SCI patients were collected retrospectively from the European Multicenter Study about Spinal Cord Injury database. We determined a cutoff walking speed at which the patients tend to walk in the community by plotting a receiver operating characteristics curve, using the Spinal Cord Independence Measure for outdoor mobility. Univariate analyses investigated which factors influence independent community ambulation. RESULTS: A walking speed of 0.59 m/s is the cutoff between patients who do and do not ambulate independently in the community, with a sensitivity of 91.6% and a specificity of 80.3%. Age, injury severity, and lower limb muscle strength have a significant influence on independent community ambulation. CONCLUSIONS: Patients with an SCI who regain a walking speed of 0.59 m/s tend to achieve a level of walking effectiveness that allows for independent community walking. Although such patients tend to be younger and less severely injured, this walking speed can be a target for locomotor training in rehabilitation and clinical trials that lead to a meaningful outcome level of community walking.

What's the best surgical treatment for patients with cervical radiculopathy due to single-level degenerative disease? A randomized controlled trial.

BACKGROUND: To investigate the efficacy of adding supplemental fusion or arthroplasty after cervical anterior discectomy for symptomatic mono-level cervical degenerative disease (radiculopathy), which has not been substantiated in controlled trials until now. METHODS: A randomized controlled trial is reported with 9 years follow up comparing anterior cervical anterior discectomy without fusion, with fusion by cage standalone, or with disc prosthesis. Patients suffering from symptomatic cervical disk degeneration at one level referred to spinal sections of department of neurosurgery or orthopedic surgery of a large general hospital with educational facilities were eligible. Neck Disability Index (NDI), McGill Pain Questionnaire Dutch language version (MPQ-DLV), physical-component summary (PCS), and mental-component summary (MCS) of the 36-item Short-Form Health Survey (SF-36), and re operation rate were evaluated. FINDINGS: 142 patients between 18 and 55 years were allocated. The median follow-up was 8.9±1.9 years (5.6 to 12.2 years). The response rate at last follow-up was 98.5%. NDI at the last follow-up did not differ between the three treatment groups, nor did the secondary outcomes as MPQ-DLV and PCS or MCS from SF-36. The major improvement occurred within the first 6 weeks after surgery. Afterward, it remained stable. Eleven patients underwent surgery for recurrent symptoms and signs due to nerve root compression at the index or adjacent level. CONCLUSIONS: This randomized trial could not detect a difference between three surgical modalities for treating a single-level degenerative disk disease. Anterior cervical discectomy without implant seems to be similar to anterior cervical discectomy with fusion by cage stand-alone or with disk prosthesis. Due to the small study sample size, this statement should be considered as inconclusive so far. TRIAL REGISTRATION: ISRCTN41681847.

A New Craniothoracic Mattress for Immobilization of the Cervical Spine in Critical Care Patients.

Current immobilization techniques of the cervical spine are associated with complications including pressure ulcers, discomfort, and elevated intracranial pressures with limited access to the thorax and airway. In this study, a newly developed craniothoracic immobilizer (Pharaoh mattress) for critical care patients with cervical injury was tested for its restriction of cervical movement, peak interface pressures, comfort, and radiolucency, and compared with headblocks strapped to a spineboard. Cervical movement was measured by roentgen stereophotogrammetric analysis in 5 fresh frozen cadavers. Peak interface and discomfort pressures were measured in 10 healthy volunteers. Radiographic absorption was calculated by measuring the total emission radiation with and without immobilizer. The Pharaoh mattress caused a mean restriction of 59% (SD: 15) flexion-extension, 77% (SD: 14) lateral bending, and 93% (SD: 3) rotation, compared with the unrestricted situation. No significant differences in restriction of cervical movement were found between headblocks strapped to a spineboard and the Pharaoh mattress. The mean peak pressures on the Pharaoh mattress were significantly lower than on the spineboard. Healthy volunteers gave significantly lower numeric discomfort scores on the Pharaoh mattress than on the spineboard. The Pharaoh mattress absorbed more x-rays than the spineboard. The Pharaoh mattress provides similar restriction of cervical movement compared with headblocks strapped to a spineboard but with lower interface pressures and increased comfort. This new mattress could be useful for immobilization of the cervical spine in critical care patients with mechanically instable spinal fractures.

Reporting the results of meta-analyses: a plea for incorporating clinical relevance referring to an example.

BACKGROUND CONTEXT: The results of meta-analyses are frequently reported, but understanding and interpreting them is difficult for both clinicians and patients. Statistical significances are presented without referring to values that imply clinical relevance. PURPOSE: This study aimed to use the minimal clinically important difference (MCID) to rate the clinical relevance of a meta-analysis. STUDY DESIGN: This study is a review of the literature. PATIENT SAMPLE: This study is a review of meta-analyses relating to a specific topic, clinical results of cervical arthroplasty. OUTCOME MEASURE: The outcome measure used in the study was the MCID. METHODS: We performed an extensive literature search of a series of meta-analyses evaluating a similar subject as an example. We searched in Pubmed and Embase through August 9, 2016, and found articles concerning meta-analyses of the clinical outcome of cervical arthroplasty compared with that of anterior cervical discectomy with fusion in cases of cervical degenerative disease. We evaluated the analyses for statistical significance and their relation to MCID. MCID was defined based on results in similar patient groups and a similar disease entity reported in the literature. RESULTS: We identified 21 meta-analyses, only one of which referred to MCID. However, the researchers used an inappropriate measurement scale and, therefore, an incorrect MCID. The majority of the conclusions were based on statistical results without mentioning clinical relevance. CONCLUSIONS: The majority of the articles we reviewed drew conclusions based on statistical differences instead of clinical relevance. We recommend introducing the concept of MCID while reporting the results of a meta-analysis, as well as mentioning the explicit scale of the analyzed measurement.

Restriction of Cervical Intervertebral Movement With Different Types of External Immobilizers: A Cadaveric 3D Analysis Study.

STUDY DESIGN: Cadaveric radiostereometric analysis study. OBJECTIVE: To quantify the ability of five commonly used immobilizers to restrict cervical spine movement, including intervertebral movement, in three directions. SUMMARY OF BACKGROUND DATA: Evidence about the ability of many clinically used cervical immobilizers to restrict cervical movement is limited. Furthermore, their effect on intervertebral movement is unknown. METHODS: Radiographic inert beads were implanted in the cervical vertebral bodies of five fresh-frozen human cadavers. After application of different immobilizers (Stifneck, Sternal Occipital Mandibular Immobilizer (SOMI), halo-traction, spineboard, halo-vest) and controlled flexion-extension, lateral bending, and rotation torques, radiostereometric analysis was used to determine the overall and intervertebral three-dimensional movement of each vertebral level. Restriction of cervical movement was described as a mean restriction percentage (MRP) and classified on an arbitrary basis (poor: <20%, fair: 20%-40%, moderate: 40%-60%, substantial: 60%-80%, nearly complete: >80%). RESULTS: Most of the restriction of flexion/extension was observed at C0-C1, while most rotational restriction was seen at C1-C2. Lateral bending was restricted at C1 to C7.The Stifneck provided the least immobilization with a moderate restriction of flexion-extension (MRP: 41%, SD: 14%), fair restriction of lateral bending (MRP: 29%, SD: 13%), and substantial restriction of rotation (MRP: 64%, SD: 15%). The halo-vest was the most restrictive immobilizer and reduced movement of the cervical spine substantially for flexion-extension (MRP: 70%, SD: 11%), substantially for lateral bending (MRP: 77%, SD: 14%), and nearly complete for rotation (MRP: 92%, SD: 3%). CONCLUSION: The restriction of movement from lowest to highest was: Stifneck, SOMI, halo-traction, head blocks on a spine board, and halo-vest. Notably, the standard deviations of the restrictions were smaller for the cranio-thoracic devices than for the cervico thoracic devices. With this new knowledge of external immobilizers and their ability to restrict intervertebral cervical movement, their indication and application in clinical practice can be improved for all patients with (suspected) cervical injury. LEVEL OF EVIDENCE: N/A.