View clinical trials related to Intervertebral Disc Displacement.
Filter by:This study includes one type of product named C-CURVE which is a Stand-alone Cervical Interbody Cage. This product is available in two materials: PEEK and Titanium. The C-Curve Cervical Interbody Devices is one single implant used for insertion between two adjacent vertebrae (cervical spine). C-Curve has been designed to restore and/or maintain adequate interbody height, and thus help stabilize one or more cervical levels while fusion occurs. This system has also as objectives to increase of the quality of life, decrease patient's pain and decrease a potential dysphagia (clinical performances). This system must only be used in the cervical spine. This post-market clinical follow-up (PMCF) study aims to confirm the acceptable benefits/risk profile of the device for the patients and to fill essential requirements to maintain the CE mark through a clinical evaluation.
The aim of this study was to determine the Turkish validity and reliability of Lumbar Spine Surgery Expectations Survey developed by Mancuso.
Study Purpose: This study is intended to monitor outcomes for 1 year following cervical TFESI. Based on current clinic volume and enrollment rates into a current study of cervical epidural injections that is nearing completion, we conservatively estimate a study enrollment period of 18 months and a total period of 2.5 years from enrollment to final follow-up data collection. If the study were to theoretically start enrolling in July 2019, we would anticipate completion by February 2022. Objectives: 1. Determine the proportion of patients with an 80% or greater improvement in arm and neck numerical rating scale pain (NRS) score following an initial cervical transforaminal steroid injection (TFESI) at 4 weeks post-injection and the duration of response up to 12 months. 2. Determine the proportion of patients with a 50%-79% improvement in arm and neck NRS score following an initial cervical TFESI at 4 weeks post-injection and the duration of response up to 12 months. 3. Determine the proportion of patients with less than 50% improvement in arm and neck NRS score following an initial cervical TFESI at 4 weeks post-injection and the duration of response up to 12 months. 4. Determine the proportion of patients with an initial injection plus up to 3 additional injections that maintain 80% or greater, as well as 50-79%, improvement in arm and neck NRS score for up to 12 months. 5. Determine the proportion of patients with a clinically significant change in function defined by a minimally clinically significant change (MCIC) (≥10 point improvement ) or 30% improvement in Neck Disability Index (NDI) score following an initial cervical TFESI at 4 weeks post-injection and the duration of response up to 12 months. 6. Determine the proportion of patients with clinically significant improvement in the Medication Quantification Scale (MQS III) score (≥6.8 point change , equivalent to 10 oral morphine equivalents ) following an initial cervical TFESI at 4 weeks post-injection and the duration of response up to 12 months. 6. Determine the proportion of patients with clinically significant improvement in the categorical EuroQol 5 Dimensions tool (EQ-5D) defined by ≥0.03 following an initial cervical TFESI at 4 weeks post-injection and the duration of response up to 12 months. 7. Compare patient demographic, clinical, and imaging characteristics between response groups and perform predictive modeling to better understand variables that increase the likelihood of a successful clinical outcome. 8. Report adverse effects.
Rationale: Treatment with transforaminal epidural injections is part of usual care in patients suffering from lumbar radiculopathy. However, not all patients experience a satisfactory result from this treatment and it is unclear what percentage of patients responds well and if any clinical or radiological factors exist that predict a positive response. Objectives: Primary: to develop a model based on demographic, clinical and radiological parameters for prediction of treatment success after TEI Secondary: to estimate the short-term efficacy of TEI in patients with LDH and spinal stenosis based on pain, functionality and perceived recovery scores, to determine the correlation between clinical and radiological baseline parameters and physical and psychological patient outcome measures, to determine the rate of additional injections and rate of surgery after treatment with TEI, to determine the short-term (cost)effectiveness of TEI on physical and psychological patient outcome measures, and to determine the rate of complications associated with TEI Study design: Prospective cohort study Study population: Patients that are scheduled for TEI as part of usual care suffering from a new episode of lumbar radiculopathy Main study parameters/endpoints: leg and back pain scores at baseline, 30 minutes, 2 and 6 weeks after treatment. ODI, HADS, Quality of Life and PCI at baseline, 2 and 6 weeks after treatment. Perceived recovery at 2 and 6 weeks after treatment. Usage of healthcare at baseline, 2 and 6 weeks after treatment.
Disc herniation is a common cause of low back pain and leg pain. Electromyography is the only test that can objectively examine nerve damage caused by a lumbar disc herniation. This study aimed to compare the MRI findings of disc herniation and the aspects of electromyography.
The proposed investigation is a multi-center, prospective, randomized, controlled comparison of the BAGUERA®C to the control, a similar, legally marketed total disc replacement device in subjects with symptomatic cervical disc disease (SCDD). Subjects will be randomized in a 2:1 ratio to the one-level BAGUERA®C Cervical Disc Prosthesis (investigational group) or to the one-level Mobi-C® Cervical Disc (control group). Subjects enrolled in the study will be evaluated pre-operatively, at the time of surgery, discharge, and at 6 weeks, 3, 6, 12, and 24 months and then annually until 7 years post-surgery.
The aim of this study was to assessment on the interaction of spatial and temporal gait parameters and gait asymmetry in patients with Lumbar Disc Herniation (LDH) before and 15 days after surgery.
Bilateral sacroiliac joint injection in symptomatic lumbar disc prolapse under ultrasound guidance and studying the effect of this technique on pain, spine mobility and activity of daily living.
This study will be conducted at Research Institute of Traumatology and Orthopedics (NRITO) n.a. Ya.L.Tsivyan, Novosibirsk, Russia. The current study is prospective observational study to evaluate the efficacy of preoperative estimation of disc herniation recurrence among patients with lumbar disc herniation using predictive mathematical model at terms 3 years postoperatively . It is expected to enroll 350 patients aged 18-70 with lumbar disc herniation. Risk estimation of disc herniation recurrence will be evaluated preoperatively, then patient will undergo conventional microdiscectomy. Postoperative eximanation will include Visits every 6-months during 3 years to evaluate clinical outcomes.
This is a prospective, single arm clinical study to evaluate fusion status and patient reported outcomes utilizing the Stryker Tritanium® C Anterior Cervical interbody device at one or two contiguous levels. Subjects that are recommended for surgical treatment of either a 1- or 2-level ACDF (Anterior Cervical Discectomy and Fusion) between the levels of Cervical Spine 2 to Thoracic 1 (C2-T1) and diagnosed with degenerative disc disease will be screened for the study.