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Showing 1-20 of 71 trials
NCT04992572
Explore efficacy, complications, and other factors associated with anaesthetic choice- To evaluate the efficacy of local + MAC as an alternative anesthetic to general anesthesia and to analyze patients' outcomes and experiences.
NCT07469020
The goal of this interventional study is to evaluate the rate of existing lower limb peripheral artery disease (PAD) in patients with surgically lumbar spinal stenosis (LSS). PAD and LSS can present similar symptoms and it can be difficult to diagnose PAD using conventional methods, depending on the location of the arterial disease. The main questions it aims to answer are : * What's the prevalence of PAD in LSS patients? * Which exam among routine tools is the most accurate to diagnose PAD in this population? Around their surgery for LSS (a few weeks before or after), participants will be included in a vascular medicine service. After checking of eligibility criteria, they will undergo a contrast-enhanced CT scan for the diagnosis of PAD and various routine diagnostic tests: Doppler ultrasound, treadmill tests, pressure index, pulse palpation.
NCT04192591
To compile real-world outcomes of the Superion™ IDS in routine clinical practice.
NCT05029726
Opioid overuse is a widespread public health crisis in the United States with increasing rates of addiction and overdose deaths from prescription opioids. Reducing the need for opiate analgesics in the post-operative setting has become a high priority in minimizing long-term opioid use in surgical patients. This study will serve to demonstrate the efficacy of the addition of regional analgesic techniques in reducing post-operative opioid requirements in patients undergoing common lumbar spinal surgical procedures.
NCT06763224
Chronic neuropathic pain following lumbar spine surgery is often under-diagnosed and difficult to relieve. It can persist long after the operation, sometimes for months or even years, and has a major impact on the quality of life of patients who suffer from it. However, the scientific literature on the subject remains relatively poor, as evidenced by the absence of scientific studies on the prevalence of neuropathic pain after lumbar spinal surgery, whether instrumented or not. The main aim of this study is to determine whether lumbar spine surgery has an impact on the prevalence of neuropathic pain. Participants will be followed up and complete a quality-of-life questionnaire for one year after surgery.
NCT05058287
This study seeks to evaluate the impact of intra-operative topical epidural steroid usage in patients undergoing 1-2 level lumbar laminectomy. The study will examine post-operative opioid usage, length of stay, return to work, and patient reported outcomes following these procedures.
NCT05273879
Long-term clinical results of two methods of surgical treatment (spinal decompression with or without fusion) in patients with single-level lumbar stenosis will be compared. A clear framework for surgical treatment methods and standardized postoperative rehabilitation treatment will be set to obtain the maximum homogeneity of the patient groups. This trial should provide the first level of evidence for the need for spinal fusion in patients with single-level lumbar stenosis, subject to the high homogeneous comparison groups. Additional results will allow comparing the economic aspects of different surgical treatments for 2 years after surgery.
NCT04075539
The main objective of the study is to compare the efficacy on back-specific activity limitations at 4 months after-randomisation of home-based cycling using connected ergometric bicycles associated with usual care to usual care.
NCT05633550
Orthopedic surgeons often face the dilemma of whether to add fusion to a decompression procedure of the spine. Their decision mainly relies on personal experience to determine if a level is unstable preoperatively or if a specific decompression procedure might destabilize the spine. Lumbar spine flexion-extension radiographs aim to provide clinicians with images to assess the dynamism of a vertebral level, which crucial for evaluating spinal instability. However, the lack of a standardized imaging protocol for taking such flexion-extension radiographs leads to wide variability in their quality. This impacts the efficacy of radiographic measurements of angular and translational motion used for diagnosis. To effectively and reliably diagnose instability, it is crucial to control and standardize the flexion-extension radiograph protocols to promote the repeatability of intervertebral motion that characterizes a patient's full range of motion. The objective of this study is to evaluate the test-retest reliability of a standardized flexion - extension radiograph imaging protocol for the lumbar spine. This is an exploratory reliability study. A non-probability purposive sample of 45 patients with back pain from two tertiary care hospitals in The Netherlands is used. There is bo intervention. The main study parameter/endpoint is the agreement between the participants' first ("test") and second ("retest") kinematic results from their lumbar flexion-extension radiographs.
NCT03853356
This study aims to evaluate the performance and safety of the Orthoss® as a bone graft extender in lumbar spondylodesis involving 1-2 levels (L4-L5 and/or L5-S1).
NCT03115983
The LimiFlex™ Clinical Trial is a prospective, concurrently controlled, multi-center study to evaluate the safety and effectiveness of decompression and stabilization with the Empirical Spine LimiFlex™ Paraspinous Tension Band compared to decompression and transforaminal lumbar interbody fusion (TLIF) with concomitant posterolateral fusion (PLF) for the treatment of lumbar degenerative spondylolisthesis (Grade I per Meyerding classification) with spinal stenosis. Clinical trial sites will enroll solely LimiFlex subjects or solely TLIF/PLF subjects.
NCT03733626
The objective of this study is to perform a prospective, randomized, controlled clinical trial to compare radiographic fusion rates and patient reported outcomes, including pain and function preoperatively and postoperatively, using Depuy ViviGen® Cellular Bone Matrix mixed with cortical/cancellous allograft in conjunction with an approved Depuy Synthes pedicle screw system compared to autograft mixed with cortical/cancellous allograft in conjunction with the same DePuy Synthes pedicle screw system used for a one or two - level posterolateral lumbar fusion.
NCT06579391
The goal of this clinical trial is to prospectively evaluate the effects of essential amino acid (EAA) supplementation on the volume and structure of the muscles surrounding the spine (paraspinal musculature). The main questions it aims to answer are: * Does EAA supplementation preserve paraspinal muscle volume (PMV) and influence changes to spinal alignment following lumbar spine surgery? * Does preserving paraspinal muscle volume (PMV) improve post-operative functional status? * Does preserving PMV reduce post-operative complications, pain, and opioid consumption? Participants will be asked to: * Consume either EAA supplement or placebo (alanine) twice daily for one week before and two weeks after lumbar spine surgery * Record pain levels and medication use in a diary * Perform functional assessments at routine follow-up visits after surgery * Undergo blood draws to monitor nutrition status and health * Undergo one spine magnetic resonance imaging (MRI) before surgery as part of routine surgical planning * Undergo one additional spine MRI after surgery to monitor PMV after treatment Researchers will compare the group that consumed EAA supplement and the group that consumed placebo to see if there is a difference in paraspinal muscle volume changes and measures of spinal alignment, functional abilities, pain levels, and opioid use.
NCT06907849
This clinical trial will use the amyloid-binding radiotracer, 124I-evuzamitide, to potentially detect amyloid, in the heart and elsewhere, in patients who have a history of lumbar spinal stenosis and/or carpal tunnel syndrome.
NCT05523388
This study is to improve the understanding of the role of postural and ambulatory biomechanics for symptoms in patients with sLSS and to correlate patient-reported outcome measures (PROMs) with dynamic compensation (difference between static and dynamic sagittal spinal alignment) in patients with symptomatic lumbar spinal stenosis sLSS).
NCT04795284
The aim of this study is to compare biomechanical walking parameters between patients with symptomatic lumbar spinal stenosis and healthy elderly.
NCT04250753
The objective is to observe the evolution of walking parameters during the surgery process and find which of all calculated walking parameters represent the best indicators of functional disabilities and postoperative recovery for patient with lumbar spinal stenosis.
NCT04540068
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.
NCT05309447
This study assesses spinal imbalance and motion in patients with sLSS and elicits fatigue via back exercises and compares spinal imbalance and motion before and after the fatigue exercise and compares these to healthy controls, allowing to associate sLSS-specific motion patterns to paraspinal muscle fatigue.
NCT05791422
Degenerative lumbar spine disease is a leading cause of disability in the world; it encompasses conditions such as spondylolisthesis, disc degeneration, and lumbar spinal stenosis. Those conditions present with a variety of clinical symptoms, including lower extremity pain, weakness, and low back pain (LBP) of varying levels of severity and in severe cases urine and stool incontinence may result.