Clinical Research Directory

MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study

This prospective longitudinal study will compare incidence rates of Medicare beneficiary surgical and minimally invasive intervention post index procedure, as well as harms associated with the MILD procedure, at 24 months post-treatment with MILD, tested against a control group of similar patients that have had a comparable procedure. This study will start with patients treated with a study procedure having an index date on or after January 1, 2017, and enrollment will continue until stopped by the sponsor.

A 5-year Superion™ IDS Clinical Outcomes Post-Approval Evaluation (SCOPE)

To compile real-world outcomes of the Superion™ IDS in routine clinical practice.

Opioid Free and Opioid Based Anesthesia in Elective Lumbar Spine Surgery

This prospective, observational, non-randomized clinical study aims to evaluate the intraoperative and postoperative effects of opioid-free multimodal anesthesia compared with opioid-containing anesthesia methods in adult patients undergoing lumbar spinal surgery. Patients will be managed according to routine clinical practice and assigned to one of three groups based on the analgesic strategy used by the attending anesthesiologist: (1) opioid-free anesthesia using multimodal agents and/or erector spinae plane (ESP) block; (2) ESP block plus intraoperative opioids; or (3) opioid-based anesthesia without regional blocks. The primary objective is to compare postoperative pain control and opioid requirements within the first 48 hours after surgery. Secondary objectives include evaluating opioid-related side effects such as nausea, vomiting, pruritus, constipation, delayed mobilization, urinary retention, and postoperative complications classified according to the Clavien-Dindo system. Standard postoperative analgesia, including intravenous morphine patient-controlled analgesia (PCA), acetaminophen, and NSAIDs, will be provided for all patients. The study aims to determine whether an opioid-free multimodal analgesic approach can reduce opioid consumption and related adverse effects while maintaining adequate analgesia in patients undergoing lumbar spinal surgery.

Study Comparing Local/ MAC Anesthesia in Lumbar Decompression

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.

CLE-PAD : Prevalence of PAD in Patients With Surgically Lumbar Spinal Stenosis

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.

Presence of Dural Pulsation in Patients Diagnosed With Lumbar Spinal Stenosis

Lumbar spinal stenosis is defined as the narrowing of the spinal canal resulting from degenerative changes in the spinal joints, intervertebral discs, and the ligamentum flavum. Pressure fluctuations within the cerebral and spinal vascular systems lead to the formation of pulsations. The periodic occurrence of these pulsations in the dura mater is referred to as spinal dural pulsation.The vibratory movements of the dura mater have been interpreted as an indicator that the spinal cord is freely mobile within the subarachnoid space and not subjected to any external compression.This study aims to investigate whether the presence of dural pulsation is associated with clinical and radiological parameters in patients diagnosed with lumbar spinal stenosis

Regional Anesthesia in Minimally Invasive Lumbar Spine Surgery

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.

Continuous Erector Spinae Block for Analgesia Following Lumbar Decompression

Lumbar spinal surgery is common, and the incidence of spinal fusion has increased dramatically over the past three decades. Patients requiring spinal surgery are typically prescribed several analgesics, (including opioids) while awaiting surgery. Postoperatively, use of high doses of opioids or anti-inflammatory medications have drawbacks. Severe post-operative pain is reported by 45-80% of patients and rates are generally higher in the opioid tolerant patients. Regional anesthesia (blocking nerves with local anesthetics) works locally, thereby avoiding many side effects associated with other analgesics. One type of nerve block is called erector spinae plane block (ESP). Single injection nerve blocks have been found to decrease pain, nausea, and opioid consumption, while increasing patient satisfaction and quality of recovery. However, these effects only last for 24 hours or less while the worst pain occurs around 36 hours after surgery. Surgeon-placed indwelling catheters could allow infusions of local anesthetics for 54 hours. This randomized control trial seeks to assess the effectiveness of surgeon-placed ESP catheters for pain control after lumbar spine surgery. Hypothesis: Patients receiving a cESP will have less pain, improved quality of recovery, and opioid use following lumbar fusion surgery than those receiving current standard of care pain management. Methodology: Adult patients undergoing lumbar spine surgery under orthopedic surgery in Halifax will be eligible. The study will include 100 participants, randomly assigned to 2 study arms of 50 participants (1:1 basis to Ropivacaine and placebo groups). At the end of surgery, the surgeon will place the ESP catheters in all study patients under sterile conditions before closing the wound. Ropivacaine 0.5% or normal saline (placebo) 15ml will be injected through each catheter (total 30ml). In the postanesthetic care unit (PACU), two elastomeric pumps will be attached to the ESP catheters. These will be filled with either Ropivacaine 0.2% or normal saline (placebo). The elastomeric pumps are small bottle that patients can carry with them after discharge home. The pumps automatically run at an infusion rate of 10 ml/hr for 54 hours. All patients will also receive the standard of care for pain management for this patient population, which is opioid based with acetaminophen. A quality of recovery (QoR-15) questionnaire will be completed at 72 hours post-operatively. Pain, catheter complication, and opioid use data will be gathered from the patient's charts at 24, 48, and 72 hours post-operatively. At 3- and 6-month follow-ups, patients will complete the Brief Pain Inventory questionnaire. We will analyze differences in pain and opioid consumption at 24, 48, and 72 hours, quality of recovery index scores at 72 hours, postoperative complication rates, and persistent pain at 3 and 6 months.

Lumbar Steroid Use in Patients Undergoing Posterior Lumbar Decompression

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.

Gait and Paraspinal sEMG in Degenerative Spinal Diseases

This cross-sectional observational study aims to quantitatively compare three-dimensional gait parameters, surface electromyography (EMG) patterns, and radiological parameters among patients with different degenerative spinal conditions-including lumbar disc herniation (LDH), lumbar spinal stenosis (LSS), lumbar sagittal imbalance (LSI), degenerative lumbar scoliosis (DLS), and cervical spondylotic myelopathy (CSM)-alongside a healthy control group. The analysis focuses on spatiotemporal gait characteristics (step length, stride length, cadence), lower limb kinematics and kinetics (hip/knee/ankle joint angles, moments, and powers during stance and swing phases), and surface EMG amplitudes (thoracic erector spinae, multifidus, gluteus maximus, and rectus abdominis muscles) during standardized walking tasks. Additionally, radiological parameters (e.g., pelvic incidence-lumbar lordosis mismatch, C2-C7 sagittal vertical axis, coronal Cobb angle) will be correlated with gait and muscle activation deviations. The study employs motion capture systems, force plates, and high-density EMG to objectively differentiate disease-specific movement impairments. Findings from this study may establish biomechanical and neuromuscular signatures for each degenerative condition, providing a framework for personalized rehabilitation strategies, gait retraining, and surgical outcome assessment in spinal disorders. Comparative analysis with healthy controls will further elucidate pathological alterations in gait and muscle recruitment patterns caused by degenerative spinal diseases.

Effectiveness and Safety of Korean Medicine for Low Back Pain or Sciatica Due to Lumbar Stenosis/Spondylolisthesis

A prospective observational study investigating the effectiveness and safety of integrative Korean medicine treatment in lumbar stenosis or spondylolisthesis patients with low back pain or sciatica at 3 locations of Jaseng Hospital of Korean Medicine as assessed through of pain, functional disability, walking ability, and quality of life patient-reported outcomes

Necessity of Fusion Following Decompression Surgery in Patients With Single-level Lumbar Stenosis

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.

Lumbosacral Spinal Stenosis - Non-Invasive Postural Therapy for Older Adult Veterans

Lumbosacral spinal stenosis (LSS) is a leading cause of limited mobility, reduced independence, and poor health outcomes in older adults, and is very common in older adult Veterans. Several years ago, major research studies indicated that surgery for LSS was more effective than usual (medical) management. Nonetheless, there are many patients for whom surgery is not the ideal therapy. There have been reports that modifications in daily activities including temporary use of a modified rolling walker and changes in sleep positioning may help relieve LSS. The investigators have assembled a VA team to study this carefully. The investigators will recruit a small group of older adult Veterans with LSS to try out this program; the investigators will monitor them closely for relief of their symptoms and improvements in walking. The investigators will, as part of this small study, try to understand potential barriers to use of this therapy. The investigators will interview the Veterans and healthcare providers to identify problems that may arise in trying this therapy. If this small study works, the investigators plan to expand the effort.

Decompressive Laminectomy Versus Laminectomy With Transpedicular Fixation in Lumbar Spinal Stenosis

Lumbar spinal stenosis is a condition where the spinal canal becomes narrowed and can cause symptoms such as back pain, numbness, leg pain, and difficulty walking. Surgery is often considered when symptoms do not improve with medical treatment. This study will compare two types of surgery used to treat lumbar spinal stenosis: decompressive laminectomy alone and decompressive laminectomy with transpedicular screw fixation. Patients will be randomly assigned to one of the two surgical options. The purpose of this study is to determine which approach provides better pain relief, improved function, fewer complications, and better spinal stability after surgery.

Analysis of Lumbar Spine Stenosis Specimens for Identification of Transthyretin Cardiac Amyloidosis

Primary objective: To identify older adults with transthyretin cardiac amyloidosis (ATTR-CA) early in the course of the illness, at a time when disease modifying therapies are most effective. The specific aims of this epidemiologic investigation include: 1. To identify subjects with previous lumbar spinal stenosis (LSS) Surgery who have evidence of transthyretin (TTR) amyloid deposits in spinal specimens and could be at risk for ATTR cardiac amyloidosis. 2. To evaluate for ATTR-CA among those with localized TTR in the spinal tissue. The study will also explore the following: 1. The prevalence of amyloid in lumbar spinal stenosis specimens by Congo Red staining. 2. The prevalence of TTR deposits among subjects with amyloid as determined by mass spectrometry. 3. Evaluation of a novel artificial intelligence technique for that can identify amyloid histologically with standard H\&E staining. 4. Difference in ATTR-CA prevalence between subjects with TTR and indeterminate amyloid deposits in subject's spine by myocardial uptake of technetium pyrophosphate scan (Tc99-PYP).

Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device

This is a prospective, multi-center open-label single arm post-market study where the purpose is to evaluate the effectiveness and safety of the market approved Spinal Simplicity Minuteman G5 MIS Fusion Plate and bone graft material in patients with degenerative conditions of the lumbar spine resulting in chronic low back pain with lower extremity symptoms and concurrent neurogenic claudication. The indication for the device under study is degenerative conditions of the lumbar spine resulting in back pain with lower extremity symptoms and neurogenic claudication.

SLIP II Registry: Spinal Laminectomy Versus Instrumented Pedicle Screw Fusion

The purpose of the project is to perform an RCT comparing patient satisfaction and outcome with or without the use of an expert panel. The purpose is also to create a registry to compare the effectiveness of decompression alone versus decompression with fusion for patients with degenerative grade I spondylolisthesis and symptomatic lumbar spinal stenosis. Primary analysis will focus on the patients' improvement from baseline patient-reported outcome questionnaires. In addition, the SLIP II registry aims to (i) develop an algorithm which could identify cases in which surgical experts are likely to recommend one treatment (i.e. \>80% of experts recommend one form of treatment) and (ii) develop a radiology-based machine learning algorithm that would prospectively classify patients as either 'stable' or 'unstable.' In addition to patient reported outcomes, step counts will be collected in order to determine the correlation of step count with patient-reported outcomes (ODI and EQ-5D) and the need for re-operation. This registry portion of the study aims to prospectively collect comparative data for these patients treated with either decompression alone or decompression with fusion.

Flexion-Extension Radiograph Imaging Protocol Reliability Study

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.

Evidence For Fusion In Spine With Orthoss®

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).

Neuropathic Pain in Patients With Degenerative Lumbar Stenosis

Pre- and postoperative pain in patients with degenerative stenosis requires great attention, as it can mislead the doctor about treatment tactics. Neuropathic pain in the legs before and after the surgical procedure, as well as the residual or recurrent pain syndrome existing against this background, overshadow the patient's recovery and cast doubt on the fullness of the performed decompression. Neural compression in the spinal canal and back pain may be the cause of the patient's antalgic posture and sagittal imbalance as seen on X-Ray, to need for corrective interventions surgical procedure. Thus, it is necessary to clarify the role and the influence of the pain and its type on the perioperative period in patients with degenerative lumbar spinal stenosis.

Efficacy of M640 in Acute Lumbosacral Musculoskeletal Conditions.

The goal of this clinical trial is to learn if a modification to metaxalone 640 mg can reduce low back and leg pain. The participants will be 18 to 80 years old, healthy with newly occurring back or leg pain. The main question aims to compare a group taking active treatment and a group taking a look-alike substance containing no active treatment. All participants will answer questions on Day 1, before treatment, and on 7-day after treatment, about: * Amount and quality of pain * Interference with physical activity * Interference with sleep

LimiFlex Clinical Trial for the Treatment of Degenerative Spondylolisthesis With Spinal Stenosis

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.

Artificial Intelligence (AI)-Based Prediction of Treatment Response in Sciatica Patients Receiving Transforaminal Epidural Steroid Injection

This prospective observational study aims to develop artificial intelligence (AI)-based predictive models to estimate treatment response in patients with sciatica undergoing transforaminal epidural steroid injection (TFESI). Approximately 1500 adult patients diagnosed with sciatica and scheduled for TFESI at Marmara University Training and Research Hospital Algology Clinic will be enrolled. Clinical, radiological, laboratory, and psychological data will be systematically collected before the procedure and at multiple follow-up points (1 hour, 3 weeks, 3 months, and 6 months post-treatment). Pain relief, measured by a 50% or greater reduction in the Numeric Rating Scale (NRS), will be the primary outcome. The study will use these comprehensive data sets to train and validate AI algorithms, aiming to create a decision-support system that can predict individual patient responses to TFESI and improve personalized treatment planning.

Is it Really Necessary Going All Over the Top in Patients With Symptomatic Lumbar Spinal Stenosis?

The goal of this clinical trial is to evaluate the theory of epidural pressure by comparing a surgical procedure that aims to perform less bone resection compared to conventional surgery in patients with lumbar spinal stenosis. The main questions it aims to answer is: Is bony decompression of the lumbar canal performed until normalization of epidural pressure not inferior to conventional surgery in achieving clinical improvement in patients with symptomatic lumbar canal stenosis? Researchers will: Compare conventional open laminectomy to bony decompression of the lumbar canal until normalization of epidural pressure is achieved. Participants will: * Be randomized to one of the two surgical interventions: laminectomy guided by epidural pressure measure or conventional laminectomy. * Visit the clinic for checkups and tests until 1 year of follow-up.