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Study protocol for an observational study of cerebrospinal fluid pressure in patients with degenerative cervical myelopathy undergoing surgical deCOMPression of the spinal CORD: the COMP-CORD study.

ABSTRACT: INTRODUCTION:Degenerative cervical myelopathy (DCM) is a disabling spinal disorder characterised by sensorimotor deficits of upper and lower limbs, neurogenic bladder dysfunction and neuropathic pain. When suspected, cervical MRI helps to reveal spinal cord compression and rules out alternative diagnoses. However, the correlation between radiological findings and symptoms is weak. Cerebrospinal fluid pressure (CSFP) analysis may complement the appreciation of cord compression and be used for intraoperative and postoperative monitorings in patients undergoing surgical decompression. METHODS AND ANALYSIS:Twenty patients diagnosed with DCM undergoing surgical decompression will receive standardised lumbar CSFP monitoring immediately before, during and 24?hours after operation. Rest (ie, opening pressure, CSF pulsation) and stimulated (ie, Valsalva, Queckenstedt's) CSFP-findings in DCM will be compared with 20 controls and results from CSFP monitoring will be related to clinical and neurophysiological findings. Arterial blood pressure will be recorded perioperatively and postoperatively to calculate spinal cord perfusion pressure and spinal vascular reactivity index. Furthermore, measures of CSFP will be compared with markers of spinal cord compression by means of MR imaging. ETHICS AND DISSEMINATION:The study protocol conformed to the latest revision of the Declaration of Helsinki and was approved by the local Ethics Committee of the University Hospital of Zurich (KEK-ZH number PB-2016-00623). The main publications from this study will cover the CSFP fluid dynamics and pressure analysis preoperative, perioperative and postoperative correlated with imaging, clinical scores and neurophysiology. Other publications will deal with preoperative and postoperative spinal perfusion. Furthermore, we will disseminate an analysis on waveform morphology and the correlation with blood pressure and ECG. Parts of the data will be used for computational modelling of cervical stenosis. TRIAL REGISTRATION NUMBER:ClinicalTrials.gov Registry (NCT02170155).

SUBMITTER: Zipser CM

PROVIDER: S-EPMC7507854 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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Study protocol for an observational study of cerebrospinal fluid pressure in patients with degenerative cervical myelopathy undergoing surgical deCOMPression of the spinal CORD: the COMP-CORD study.

Zipser Carl Moritz CM Pfender Nikolai N Spirig Jose Miguel JM Betz Michael M Aguirre Jose J Hupp Markus M Farshad Mazda M Curt Armin A Schubert Martin M

BMJ open 20200921 9

<h4>Introduction</h4>Degenerative cervical myelopathy (DCM) is a disabling spinal disorder characterised by sensorimotor deficits of upper and lower limbs, neurogenic bladder dysfunction and neuropathic pain. When suspected, cervical MRI helps to reveal spinal cord compression and rules out alternative diagnoses. However, the correlation between radiological findings and symptoms is weak. Cerebrospinal fluid pressure (CSFP) analysis may complement the appreciation of cord compression and be used ...[more]

PMID: 32958488

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Project description: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.

Project description:Background: Degenerative cervical myelopathy (DCM), also known as cervical spondylotic myelopathy is the leading cause of spinal cord compression in adults. The mainstay of treatment is surgical decompression, which leads to partial recovery of symptoms, however, long term prognosis of the condition remains poor. Despite advances in treatment methods, the underlying pathobiology is not well-known. A better understanding of the disease is therefore required for the development of treatments to improve outcomes following surgery. Objective: To systematically evaluate the pathophysiology of DCM and the mechanism underlying recovery following decompression. Methods: A total of 13,808 published articles were identified in our systematic search of electronic databases (PUBMED, WEB OF SCIENCE). A total of 51 studies investigating the secondary injury mechanisms of DCM or physiology of recovery in animal models of disease underwent comprehensive review. Results: Forty-seven studies addressed the pathophysiology of DCM. Majority of the studies demonstrated evidence of neuronal loss following spinal cord compression. A number of studies provided further details of structural changes in neurons such as myelin damage and axon degeneration. The mechanisms of injury to cells included direct apoptosis and increased inflammation. Only four papers investigated the pathobiological changes that occur in spinal cords following decompression. One study demonstrated evidence of axonal plasticity following decompressive surgery. Another study demonstrated ischaemic-reperfusion injury following decompression, however this phenomenon was worse when decompression was delayed. Conclusions: In preclinical studies, the pathophysiology of DCM has been poorly studied and a number of questions remain unanswered. The physiological changes seen in the decompressed spinal cord has not been widely investigated and it is paramount that researchers investigate the decompressed spinal cord further to enable the development of therapeutic tools, to enhance recovery following surgery.

Project description:Background and purposeAlthough current radiologic evaluation of degenerative cervical myelopathy by conventional MR imaging accurately demonstrates spondylosis or degenerative disc disease causing spinal cord dysfunction, conventional MR imaging still fails to provide satisfactory anatomic and clinical correlations. In this context, we assessed the potential value of quantitative cervical spinal cord T1 mapping regarding the evaluation of patients with degenerative cervical myelopathy.Materials and methodsTwenty patients diagnosed with mild and moderate-to-severe degenerative cervical myelopathy and 10 healthy subjects were enrolled in a multiparametric MR imaging protocol. Cervical spinal cord T1 mapping was performed with the MP2RAGE sequence procedure. Retrieved data were processed and analyzed regarding the global spinal cord and white and anterior gray matter on the basis of the clinical severity and the spinal canal stenosis grading.ResultsNoncompressed levels in healthy controls demonstrated significantly lower T1 values than noncompressed, mild, moderate, and severe stenotic levels in patients. Concerning the entire spinal cord T1 mapping, patients with moderate-to-severe degenerative cervical myelopathy had higher T1 values compared with healthy controls. Regarding the specific levels, patients with moderate-to-severe degenerative cervical myelopathy demonstrated a T1 value increase at C1, C7, and the level of maximal compression compared with healthy controls. Patients with mild degenerative cervical myelopathy had lower T1 values than those with moderate-to-severe degenerative cervical myelopathy at the level of maximal compression. Analyses of white and anterior gray matter confirmed similar results. Strong negative correlations between individual modified Japanese Orthopaedic Association scores and T1 values were also observed.ConclusionsIn this preliminary study, 3D-MP2RAGE T1 mapping demonstrated increased T1 values in the pathology tissue samples, with diffuse medullary alterations in all patients with degenerative cervical myelopathy, especially relevant at C1 (nonstenotic level) and at the maximal compression level. Encouraging correlations observed with the modified Japanese Orthopaedic Association score make this novel approach a potential quantitative biomarker related to clinical severity in degenerative cervical myelopathy. Nevertheless, patients with mild degenerative cervical myelopathy demonstrated nonsignificant results compared with healthy controls and should now be studied in multicenter studies with larger patient populations.

Project description:Previous studies aimed at identifying predictors of clinical outcomes following surgical decompression for degenerative cervical myelopathy (DCM) are limited by multicollinearity among predictors, whereby the high degree of correlation between covariates precludes detection of potentially significant findings. We apply partial least squares (PLS), a data-driven approach, to model multi-dimensional variance and dissociate patient phenotypes associated with functional, disability, and quality of life (QOL) outcomes in DCM. This was a post-hoc analysis of DCM patients enrolled in the prospective, multi-center AOSpine CSM-NA/CSM-I studies. Baseline clinical covariates evaluated as predictors included demographic (e.g., age, sex), clinical presentation (e.g., signs and symptoms), and treatment (e.g., surgical approach) characteristics. Outcomes evaluated included change in functional status (∆mJOA), disability (∆NDI), and QOL (∆SF-36) at 2 years. PLS was used to derive latent variables (LVs) relating specific clinical covariates with specific outcomes. Statistical significance was estimated using bootstrapping. Four hundred and seventy-eight patients met eligibility criteria. PLS identified 3 significant LVs. LV1 indicated an association between presentation with hand muscle atrophy, treatment by an approach other than laminectomy alone, and greater improvement in physical health-related QOL outcomes (e.g., SF-36 Physical Component Summary). LV2 suggested the presence of comorbidities (respiratory, rheumatologic, psychological) was associated with lesser improvements in functional status post-operatively (i.e., mJOA score). Finally, LV3 reflected an association between more severe myelopathy presenting with gait impairment and poorer mental health-related QOL outcomes (e.g., SF-36 Mental Component Summary). Using PLS, this analysis uncovered several novel insights pertaining to patients undergoing surgical decompression for DCM that warrant further investigation: (1) comorbid status and frailty heavily impact functional outcome; (2) presentation with hand muscle atrophy is associated with better physical QOL outcomes; and (3) more severe myelopathy with gait impairment is associated with poorer mental QOL outcomes.

Project description:BackgroundDegenerative cervical myelopathy (DCM) is widely accepted as the most common cause of adult myelopathy worldwide. Despite this, there is no specific term or diagnostic criteria in the International Classification of Diseases 11th Revision and no Medical Subject Headings (MeSH) or an equivalent in common literature databases. This makes searching the literature and thus conducting systematic reviews or meta-analyses imprecise and inefficient. Efficient research synthesis is integral to delivering evidence-based medicine and improving research efficiency.ObjectiveThis study aimed to illustrate the difficulties encountered when attempting to carry out a comprehensive and accurate evidence search in the field of DCM by identifying the key sources of imprecision and quantifying their impact.MethodsTo identify the key sources of imprecision and quantify their impact, an illustrative search strategy was developed using a validated DCM hedge combined with contemporary strategies used by authors in previous systematic reviews and meta-analyses. This strategy was applied to Medical Literature Analysis and Retrieval System Online (MEDLINE) and Excerpta Medica dataBASE (EMBASE) databases looking for relevant DCM systematic reviews and meta-analyses published within the last 5 years.ResultsThe MEDLINE via PubMed search strategy returned 24,166 results, refined to 534 papers after the application of inclusion and exclusion criteria. Of these, 32.96% (176/534) results were about DCM, and 18.16% (97/534) of these were DCM systematic reviews or meta-analyses. Non-DCM results were organized into imprecision categories (spinal: 268/534, 50.2%; nonspinal: 84/534, 15.5%; and nonhuman: 8/534, 1.5%). The largest categories were spinal cord injury (75/534, 13.67%), spinal neoplasms (44/534, 8.24%), infectious diseases of the spine and central nervous system (18/534, 3.37%), and other spinal levels (ie, thoracic, lumbar, and sacral; 18/534, 3.37%). Counterintuitively, the use of human and adult PubMed filters was found to exclude a large number of relevant articles. Searching a second database (EMBASE) added an extra 12 DCM systematic reviews or meta-analyses.ConclusionsDCM search strategies face significant imprecision, principally because of overlapping and heterogenous search terms, and inaccurate article indexing. Notably, commonly employed MEDLINE filters, human and adult, reduced search sensitivity, whereas the related articles function and the use of a second database (EMBASE) improved it. Development of a MeSH labeling and a standardized DCM definition would allow comprehensive and specific indexing of DCM literature. This is required to support a more efficient research synthesis.

Dataset Information

Study protocol for an observational study of cerebrospinal fluid pressure in patients with degenerative cervical myelopathy undergoing surgical deCOMPression of the spinal CORD: the COMP-CORD study.

Publications

Study protocol for an observational study of cerebrospinal fluid pressure in patients with degenerative cervical myelopathy undergoing surgical deCOMPression of the spinal CORD: the COMP-CORD study.

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