IntroductionPatients with symptomatic single-level combination of degenerative stenosis and low-grade spondylolisthesis are often treated by nerve root decompression and spinal fusion. The gold standard is traditional open decompression and fusion, but minimally invasive method is more and more prevailing. However, there is lack of high-quality studies comparing these two techniques in order to obtain the advantages and certain indications to use one of these methods. The current study includes clinical, safety and radiological endpoints to determine the effectiveness of minimally invasive decompression and fusion (MIS-TLIF) over the traditional open one (O-TLIF).Methods and analysisAll patients aged 40–75 years with neurogenic claudication or bilateral radiculopathy caused by single-level combination of degenerative stenosis and low-grade spondylolisthesis, confirmed by MRI with these symptoms persisting for at least 3 months prior to surgery, are eligible. Patients will be randomised into MIS-TLIF or traditional O-TLIF. The primary outcome measure is Oswestry Disability Index at 3-month follow-up term. The secondary outcomes are patient-reported outcome measures by the number of clinical scales, radiological parameters including sagittal balance parameters, safety endpoints and cost-effectiveness of each method. All patients will be analysed preoperatively, as well as on the 14th day of hospital stay (or on the day of hospital discharge), 3 months, 6 months, 12 months and 24 months postoperatively. The study has the design of a parallel group to demonstrate the non-inferior clinical results of MIS-TLIF compared with the traditional O-TLIF.Ethics and disseminationThe study will be performed according to Helsinki Declaration. The study protocol was approved by the Local Ethical Committee of Priorov National Medical Research Center of Traumatology and Orthopedics in August 2020. Preliminary and final results will be presented in peer-reviewed journals, especially orthopaedic and spine surgery journals, at national and international congresses.Trial registration numberNCT04594980.
Objective: The result of treatment of patients with degenerative disc diseases is partly determined by the psychological characteristics of the patients. The aim of this study was to examine the correlations between the psychological scales scores in patients with degenerative lumbar disc diseases and the effectiveness of surgical treatment. Methods: The efficacy of the operation and patients’ satisfaction were compared with the preoperative psychological characteristics, according to the questionnaires and scales (BBQ Symonds, Zung Scale, FABQ, PCI, BBQ Catastrophization). Results: In patients with neurogenic intermittent claudication syndrome without significant pain, the operative treatment depended significantly on the value of the BBQ Symonds scale (p = 0.016). In patients with severe radicular pain in the lower extremity, the effectiveness of the operation depended significantly on the value of the subscale “protection” of the PCI questionnaire (p = 0.04), the ODI index filled out before the operation (p = 0.0). In patients with lumbar syndrome, the effectiveness of operation depended significantly on the value of the PCI questionnaire as a whole (p = 0.042) and its subscores “rest” (p = 0.028), the index of the Oswestry filled out before the operation (p = 0.035). Conclusion: The effectiveness of the operation of degenerative lumbar disc diseases is associated with the results of preoperative psychological testing. It has been established that the BBQ Symonds scale, PCI protection and rest subscales, and the ODI questionnaire are the most significant; these psychological scales have the power to predict the effectiveness of surgical treatment. Level of Evidence II; Therapeutic Study - Investigating the Results of Treatment.
Lumbar intervertebral disc degeneration (DD) disease is one of the main risk factors for low back pain and a leading cause of population absenteeism and disability worldwide. Despite a variety of biological studies, lumbar DD is not yet fully understood, partially because there are only few studies that use systematic and integrative approaches. This urges the need for studies that integrate different omics (including genomics and transcriptomics) measured on samples within a single cohort. This protocol describes a disease-oriented Russian disc degeneration study (RuDDS) biobank recruitment and analyses aimed to facilitate further omics studies of lumbar DD integrating genomic, transcriptomic and glycomic data. A total of 1,100 participants aged over 18 with available lumbar MRI scans, medical histories and biological material (whole blood, plasma and intervertebral disc tissue samples from surgically treated patients) will be enrolled during the three-year period from two Russian clinical centers. Whole blood, plasma and disc tissue specimens will be used for genotyping with genome-wide SNP-arrays, glycome profiling and RNA sequencing, respectively. Omics data will be further used for a genome-wide association study of lumbar DD with in silico functional annotation, analysis of plasma glycome and lumbar DD disease interactions and transcriptomic data analysis including an investigation of differential expression patterns associated with lumbar DD disease. Statistical tests applied in each of the analyses will meet the standard criteria specific to the attributed study field. In a long term, the results of the study will expand fundamental knowledge about lumbar DD development and contribute to the elaboration of novel personalized approaches for disease prediction and therapy. Additionally to the lumbar disc degeneration study, a RuDDS cohort could be used for other genetic studies, as it will have unique omics data. Trial registration number NCT04600544.
Objective. To analyze the literature data and to present recommendations on the use of the minimum clinically important difference (MCID) in the practice of spinal surgeon-researcher.Material and Methods. The article is a non-systematic review of the literature. A search was performed for sources, which describe the calculation and analysis of the MCID parameter on a cohort of patients with degenerative spinal diseases in the PubMed, Scopus and Web of Science databases. Further, the analysis of the literature was carried out on the application of MCID to assess the effectiveness of surgical treatment.Results. The MCID parameter is illustrated for the most common clinical scales used to assess the effectiveness of treatment in spinal surgery, with their detailed description and discussion of their benefits and drawbacks. The specific MCID values for cervical and lumbar pathologies, first of all degenerative ones, and follow-up periods, which can be used in assessing the results of the treatment, as well as in planning prospective comparative studies are presented.Conclusion. The MCID parameter is required for sample size calculation and for the analysis of treatment outcomes. The MCID reflects not just the change in the baseline indicator, but also the clinical significance for the patient.
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