View clinical trials related to Intervertebral Disc Displacement.
Filter by:This research protocol seeks to compare radiological and clinical outcomes of cervical spine disease patients following standard-of-care anterior cervical discectomy and fusion (ACDF) using allograft fusion versus Cohere porous polyetheretherketone (PEEK) fusion device. This clinical study presents little to no additional risk to study subjects beyond those associated with standard-of-care ACDF surgery. Adults age 18 and over who are undergoing an ACDF procedure will be enrolled in the study. The study consists of a completing a series of questionnaires and obtaining radiographs. The primary endpoint of the study will be the rate of successful spinal fusion for each group. For evaluation of the primary endpoint and additional assessments, descriptive statistics including mean, standard deviation, minimum, median, and maximum for continuous variables and frequency distribution for categorical variables will be provided, as well as tabular listings. All complications will be itemized including incidence, duration, and relationship to the device used and/or procedures performed.
Post-Marketing Clinical Follow-up of an Anular Closure System (Barricaid®) to Confirm Comparability of Outcome between Devices with Subcomponents from Two Different Suppliers
The purpose of this study is to evaluate clinical and patient-reported outcomes at 10 years following surgery for a cohort of Mobi-C subjects treated on the IDE/Post Approval studies
A multicenter patient registry was created with aim of documenting how spine and neurosurgeons are utilizing Burst Biologics products along with patient outcomes. These include radiographic measures such as fusion outcome, instrumentation integrity, and clinical outcomes (symptom and function improvement) based on surgeon and patient based outcome assessments.
The objective of this prospective controlled crossover study is to evaluate the efficacy and safety of pentoxifylline per os (800 mg daily) in the management of lumbar radiculopathy
Background: Patients suffering residual disability after anterior decompression and fusion (ACDF) surgery for cervical disc disease may be prescribed physical activity (PPA) or neck-specific exercises (NSE). Currently, we lack data for the success of either approach. There is also a knowledge-gap concerning the use of internet-based care for chronic neck pain, inclusive of cervical disc disease. The scarcity of these data, and the high proportion of patients with various degrees of incapacity following ACDF, warrants increased efforts to investigate and improve cost-effective rehabilitation. Objective: To investigate the effectiveness of a structured, internet-based NSE program, versus PPA following ACDF surgery. Methods: This is a prospective, randomised, experimental, longitudinal multicentre study, that includes 140 patients with residual disability (≥30% on the Neck Disability Index; NDI) following ACDF for radiculopathy due to cervical disc disease. Patient recruitment occurs following attendance at routine clinical appointments, scheduled for 3-months post-surgery. Patients are then randomised to one of two groups (70 patients/group), scheduled for a 3-month treatment of either internet-based NSE or PPA. Questionnaires on background data, pain and discomfort, physical and mental capacity, satisfaction with care, and health and workplace factors are completed, with physical measurements of neck-related function performed by independent test leaders blinded to randomisation. Measurements are performed at inclusion, after the 3-month treatments (end of treatment), and at a 2-year follow-up. Radiography will be completed at the 2-year follow-up. Preoperative data will be collected from the Swedish Spine Registry (Swespine). Data on healthcare consumption, drug use, and sick leave will be requested from the relevant national registers.
Multilevel decompression and bone graft fusion is a most effective measure for treating degenerative lumbar spinal diseases. Yet, the surgery is commonly associated with large amount of perioperative blood loss and high demand for homologous blood transfusion. Tranexamic acid (TXA) has been proved as efficient in reducing the gross blood loss in various kinds of surgeries. However, high quality evidence of its efficacy and safety is still lacking in lumbar spinal surgeries. Besides, systemic use of TXA carries the risks of thromboembolic complications such as deep venous thrombosis and pulmonary embolism, thus the optimal drug delivery route of TXA remains undetermined. The aim of this study is to test the non-inferiority of topical TXA application to its intravenous use in multilevel decompression and bone graft fusion surgeries. A prospective, randomized, double-blind, head-to-head comparison study design will be adopted.
This Post Market Clinical Follow-up (PMCF) is conducted to collect clinical and radiographic outcome information on patients suffering from intractable symptomatic cervical disc disease requiring 1- or 2-level reconstruction of the disc from C3-C7, after being treated with the Triadyme-C polycrystalline diamond compact cervical disc replacement.
This is an investigator-initiated study. The primary goal is to evaluate the efficacy of two different cervical disc devices (prosthesis vs rigid spacer) with respect to postoperative change in neck disability index. The evaluation will include clinical and radiological parameters.
This is an investigator-initiated study. The primary goal is to evaluate the efficacy of two different cervical disc prosthetic devices with respect to postoperative change in neck disability index. The evaluation will include clinical and radiological parameters.