ABSTRACT
INTRODUCTION: Robotic guidance (RG) and computer-assisted navigation (NV) have seen increased adoption in instrumented spine surgery over the last decade. Although there exists some evidence that these techniques increase radiological pedicle screw accuracy compared with conventional freehand (FH) surgery, this may not directly translate to any tangible clinical benefits, especially considering the relatively high inherent costs. As a non-randomised, expertise-based study, the European Robotic Spinal Instrumentation Study aims to create prospective multicentre evidence on the potential comparative clinical benefits of RG, NV and FH in a real-world setting. METHODS AND ANALYSIS: Patients are allocated in a non-randomised, non-blinded fashion to the RG, NV or FH arms. Adult patients that are to undergo thoracolumbar pedicle screw instrumentation for degenerative pathologies, infections, vertebral tumours or fractures are considered for inclusion. Deformity correction and surgery at more than five levels represent exclusion criteria. Follow-up takes place at 6 weeks, as well as 12 and 24 months. The primary endpoint is defined as the time to revision surgery for a malpositioned or loosened pedicle screw within the first postoperative year. Secondary endpoints include patient-reported back and leg pain, as well as Oswestry Disability Index and EuroQOL 5-dimension questionnaires. Use of analgesic medication and work status are recorded. The primary analysis, conducted on the 12-month data, is carried out according to the intention-to-treat principle. The primary endpoint is analysed using crude and adjusted Cox proportional hazards models. Patient-reported outcomes are analysed using baseline-adjusted linear mixed models. The study is monitored according to a prespecified monitoring plan. ETHICS AND DISSEMINATION: The study protocol is approved by the appropriate national and local authorities. Written informed consent is obtained from all participants. The final results will be published in an international peer-reviewed journal. TRIAL REGISTRATION NUMBER: Clinical Trials.gov registry NCT03398915; Pre-results, recruiting stage.
Subject(s)
Lumbar Vertebrae , Pedicle Screws/adverse effects , Postoperative Complications , Reoperation , Robotic Surgical Procedures , Spinal Diseases , Spinal Fusion , Thoracic Vertebrae , Europe/epidemiology , Female , Humans , Lumbar Vertebrae/diagnostic imaging , Lumbar Vertebrae/surgery , Male , Middle Aged , Multicenter Studies as Topic , Observational Studies as Topic , Outcome Assessment, Health Care , Postoperative Complications/diagnosis , Postoperative Complications/etiology , Postoperative Complications/surgery , Reoperation/methods , Reoperation/statistics & numerical data , Robotic Surgical Procedures/adverse effects , Robotic Surgical Procedures/instrumentation , Robotic Surgical Procedures/methods , Spinal Diseases/diagnostic imaging , Spinal Diseases/epidemiology , Spinal Diseases/surgery , Spinal Fusion/adverse effects , Spinal Fusion/instrumentation , Spinal Fusion/methods , Surgery, Computer-Assisted/adverse effects , Surgery, Computer-Assisted/instrumentation , Surgery, Computer-Assisted/methods , Thoracic Vertebrae/diagnostic imaging , Thoracic Vertebrae/surgeryABSTRACT
Peptides, such as many hormones, cytokines and growth factors play a central role in biological processes. Furthermore, as degradation products and processed forms of larger proteins they are part of the protein turnover. Thus, they can reflect disease-related changes in an organism's homeostasis in several ways. Since two-dimensional gel electrophoresis is restricted to analysis and display of proteins with relative molecular masses above 5000, we developed Differential Peptide Display (DPD), a new technology for analysis and visualization of peptides. Here we describe its application to cerebrospinal fluid of three subjects without a disease of the central nervous system (CNS) undergoing routine myelography and of two patients suffering from a primary CNS lymphoma. Peptides with a relative molecular mass below 20000 were extracted and analysed by a combination of chromatography and mass spectrometry. The peptide pattern of a sample was depicted as a multi-dimensional peptide mass fingerprint with each peptide's position being characterized by its molecular mass and chromatographic behaviour. Such a fingerprint of a CNS sample consists of more than 6000 different signals. Data analysis of peptide patterns from patients with CNS lymphoma compared to controls revealed obvious differences regarding the peptide content of the samples. By analysing peptides within a mass range of 750-20000, DPD extends 2D gel electrophoresis, thus offering the chance to investigate CNS diseases on the level of peptides. This represents a new approach for diagnosis and possible therapy.
