Spinal Stenosis

The purpose of this multi-center, prospective, observational registry is to gather information on the clinical outcomes and real-world use of commercially available bone graft substitutes manufactured by OssDsign® AB, in patients who require spine fusion.

Spinal conditions are a major public health issue. Their management by surgical treatment is constantly improving and surgical procedures or implantable medical devices are experiencing significant progress. These innovations have not yet all been precisely evaluated but have already led to significant changes in care practices. The primary objective of our study is to describe, via an exhaustive collection of data, the quarterly evolution over 5 years of practices in the management of spinal pathologies.

This is a prospective, multi-center, observational Post-Market Clinical Follow-Up (PMCF) study designed to collect additional safety and clinical performance data on CE-marked Titania® spinal instrumentation and fusion systems, and Bonegraft® bone filling materials (synthetic bone grafts and bone cements). The study aims to evaluate short-term (12-month) safety and effectiveness, identify previously unknown side effects, monitor defined complications, and assess risks based on real-world evidence in patients undergoing spinal surgery. All investigated products are used within their intended purpose under routine clinical practice.

The goal of this clinical study is to learn how blood glucose levels change after an epidural steroid injection (ESI) with dexamethasone in adults. It will specifically compare the glycemic response between patients with type 2 diabetes and those without diabetes. The main questions it aims to answer are: Does the injection cause higher or longer-lasting blood glucose elevation in diabetic patients compared to non-diabetic patients? How do the mean glucose level and Time in Range (TIR) change after the injection in both groups? Researchers will compare a Type 2 Diabetes group to a Non-Diabetes group to see the differences in glycemic fluctuations using a continuous glucose monitoring (CGM) device. Participants will: * Wear a small CGM sensor on their arm for about 15 days to monitor blood glucose levels continuously * Receive an epidural steroid injection containing 5 mg of dexamethasone on Day 3 * Visit the clinic 3 times (Day 1, Day 3, and Day 15) for sensor attachment, the injection procedure, and data collection

The goal of this clinical trial is to evaluate safety and tolerability of multiple oral doses of EC5026 in male and female patients with neuropathic pain due to traumatic or non-traumatic (degenerative) spinal cord injury. The main question it aims to answer is whether EC5026 is safe and well tolerated in SCI patients with neuropathic pain. In addition, this trial will also study the effects of EC5026 on pain. Researchers will compare EC5026 to placebo. Participants will be asked to: * Take EC5026 or placebo in a masked fashion, once daily, for 14 consecutive days. * Undergo physical exams, vital signs assessments, ECGs, and blood draws * Complete assessments of pain, sleep, functional status, and perception of change

The investigators aim to compare the postoperative analgesic efficacy of the classical thoracolumbar interfascial plane block and the Quadro-iliac plane block for postoperative analgesia management after lumbar disc surgery.

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.

Research Rationale and Study Design Lumbar spinal stenosis (LSS) is a common degenerative musculoskeletal disorder characterized by narrowing of the spinal canal, often leading to pain and disability. One of the primary contributors to this condition is hypertrophy (thickening) of the ligamentum flavum (LF), along with facet joint degeneration, intervertebral disc herniation, and ligament ossification. However, the pathophysiological mechanisms behind these changes remain incompletely understood. Histological changes in hypertrophied LF include fibrocartilaginous metaplasia, type II collagen proliferation, ossification, calcium crystal deposition, and degeneration of elastic and collagen fibers. Both mechanical stress and inflammatory processes, particularly macrophage infiltration, are considered key contributors to degeneration, especially in the aging population. Yet, inflammation linked to systemic metabolic disorders-such as obesity and sarcopenia-may also significantly influence the degeneration of spinal structures. Metabolic Inflammation and the Role of Adipokines Recent research has highlighted the role of adipokines in the pathogenesis of degenerative spinal and joint diseases. Disrupted lipid metabolism and chronic low-grade inflammation contribute to tissue remodeling, extracellular matrix (ECM) degradation, and ectopic fat deposition in spinal structures. Epidural fat, normally present in the spinal canal, can become inflamed and secrete pro-inflammatory cytokines, potentially affecting adjacent tissues such as muscles and ligaments. Conditions like spinal epidural lipomatosis, which is associated with obesity, exemplify this pathological mechanism. While adipokines like leptin and visfatin have been previously associated with LF ossification and degeneration, the presence and role of others-such as adipsin, vaspin, resistin, lipocalin-2, progranulin, chemerin, omentin-1, and GDF-15-have not yet been studied in LF or epidural fat. Given their known effects on inflammation and ECM remodeling, these molecules are strong candidates for involvement in spinal canal narrowing. Research Hypotheses and Objectives This study hypothesizes that adipose tissue-derived cytokines, particularly from epidural fat, contribute to LF degeneration and LSS through inflammatory and metabolic signaling. The main research objectives are to: 1. Identify differences in biomarker concentrations in LF, paraspinal muscle, and epidural fat from patients with and without LSS. 2. Determine correlations between tissue and blood biomarker levels and clinical parameters such as pain, disability, and body mass. 3. Select potential biomarkers for monitoring surgical outcomes of spinal decompression. 4. Identify cytokines that modulate LF inflammation and metabolism. 5. Evaluate the direct effects of adipokines on LF cell behavior in vitro. Study Design and Methods Study population: • 100 patients undergoing lumbar spine surgery at the Orthopaedic-Rehabilitation Clinical Hospital in Poznań: o 50 with LSS (ages 40-90) * 50 with disc herniation only (ages 18-40; control group) Tissue collection (intraoperative): • Ligamentum flavum • Paraspinal muscles • Epidural adipose tissue Blood samples: • Collected from all participants: o Within 48 hours before surgery o Two months post-surgery Clinical assessments: • Disability and pain scales * Preoperative MRI scans Laboratory analysis: • Molecular testing: * mRNA expression of selected cytokines and adipokines using PCR * Protein levels determined via ELISA in both serum and tissue homogenates • Cell culture studies: * One-third of collected tissue is used to establish primary cell cultures from LF, paraspinal muscles, and epidural fat * Cells will be stimulated with conditioned media from epidural fat and with selected recombinant cytokines (e.g., vaspin, lipocalin-2, GDF-15) * Experiments will assess the gene and protein expression of key molecules involved in inflammation, ECM remodeling, bone metabolism, fibrosis, and matrix degradation. The goal is to clarify the local and systemic roles of adipokines and inflammation in the pathogenesis of LF hypertrophy and LSS. This knowledge may aid in identifying biomarkers for disease progression and therapeutic targets for non-surgical interventions in the future.

Establish a data repository of patients who have undergone single, two-, or three-level lumbar instrumented arthrodesis procedures supplemented by the Implanet Jazz System.

This randomised controlled trial will evaluate the comparative effects of Maitland versus Mulligan spinal mobilization techniques, when combined with canal enlargement exercises, in patients with lumbar spinal stenosis (LSS). A total of 38 participants aged 25-40 years with confirmed unilateral LSS will be randomly assigned to receive either Maitland mobilizations or Mulligan mobilizations, along with standard physiotherapy and canal enlargement exercises. The intervention will be administered over three weeks, with four sessions per week. Primary outcomes will include pain intensity (measured by Numeric Pain Rating Scale), disability (Modified Oswestry Disability Index), and symptom severity (Swiss Spinal Stenosis Score), assessed at baseline and post-treatment. This study aims to inform physiotherapy practice by identifying the more effective manual therapy technique for improving functional outcomes in LSS.

This is a randomized controlled multicenter trail comparing physical therapy to surgical decompression in patients with lumbar spinal stenosis. The 0-hypothesis is that there is no difference in the efficacy of structured physical therapy compared to surgical decompression. Our aim is to evaluate if physical therapy can serve as a nonsurgical alternative for patients with LSS, where the severity of symptoms indicates the need of surgical decompression.

The overarching aim of this project is to modulate the pulse-width during stimulation of pedicle screws and record the response thresholds associated with each PWM setting. During this initial phase of the investigation, no further data will be collected.

The goal of this clinical trial is to learn about the effect of ketamine on intraoperative motor evoked potentials in adult patients undergoing thoracolumbar spinal fusions. Participants will undergo a standard anesthetic. In addition to the standard anesthetic, the patients will be administered increasing doses of ketamine with motor-evoked potentials being measured at each dose, to assess any impacts.

The recent development and expansion of endoscopic surgery has made it possible to offer an alternative to this therapeutic escalation. This method allows decompression procedures to be performed using optimized and minimally destructive surgical approaches, which contributes to preserving the physiological function of the lumbar spine and in particular its stability. The main hypothesis of the research is that the use of endoscopic techniques for decompression of the lumbar spine allows a reduction in the indication for lumbar arthrodesis.

To assess the need for additional fusion surgery versus the risk of a revision surgery in patients with degenerative lumbar spinal disease and to assess efficacy and risk of the ligamentous fixation technique (vertebropexy)

The present study aims to adapt and modify a brief presurgical Acceptance and Commitment Therapy (ACT) intervention aimed at preventing the transition to Chronic Post-Surgical Pain (CPSP) and reducing long-term opioid use. Investigators will then assess the acceptability, feasibility, and preliminary efficacy of the finalized intervention to prevent the transition to CPSP and reduce post-surgical opioid use six months following lumbar spine surgery. Finally, investigators will identify psychosocial and psychophysical phenotypes associated with response to this intervention.

The primary objective of the study is a data collection initiative. The study will collect clinical and radiographic outcomes of patients implanted with patient specific rods. The secondary objective is to collect clinical and radiographic outcomes of patients with hardware as a control cohort to the patient-specific rods.

elderly patients in our hospital who received spinal fusion surgery after the year 2025 will receive ERAS treatment.

This study is a prospective, single-center, randomized controlled trial to compare whether applying cognitive intervention therapy before and after surgery in elderly patients aged 65 years or older undergoing non-cardiac surgery can reduce the incidence of postoperative delirium compared to conservative treatment.

Our primary objective is to design a cohort to determine the treatment outcome of different surgical interventions of the degenerative lumbar spine highlighting the expediency and value of the current surgical treatment program.

This study investigates the effect of hospital-based intensive non-surgical treatment in musculoskeletal patients admitted to an integrated hospital that offers both complementary and alternative medicine (CAM) and conventional medicine treatment.

Deep surgical site infection (DSSI) is one of the most challenging complications for spinal surgeons and can lead to a poor clinical outcome. This ambispective study was designed to examine the effect of vancomycin powder mixed with autogenous bone graft and bone substitute on preventing deep surgical site infection (DSSI) in degenerative lumbar fusion surgeries as well as any interference with bony fusion.