Clinical Research Directory

Clariance ErYs Registry

International, prospective, single arm, multicenter and observational Post-Market Clinical Follow-up (PMCF). The overall objective of this study is to collect preoperative, intraoperative and postoperative (at 9 weeks, 6 months, 1 year and 2 years) data on the clinical complications and functional outcomes of the study devices to demonstrate safety and performance in a real-world setting. The primary objective is to demonstrate that the use of the study devices is safe. The secondary objective is to demonstrate that the use of the study devices decreases the pain, and improves the quality of life and the daily activities of the subjects.

Pre-operative Risk Assessment Combined With Targeted Intervention in the Chinese Elderly With Spine Surgery II

This multicenter, parallel-group, assessor-blinded randomized controlled trial will enroll 248 adults aged ≥75 years with degenerative lumbar spinal diseases scheduled for elective lumbar fusion surgery, and they will be randomized 1:1 into the intervention and usual care groups. The intervention group will receive a 6-week PHYSIO-Prehab multimodal prehabilitation program, including multicomponent exercise, nutritional intervention, comorbidity optimization, and cognitive prehabilitation with brain protection strategies. The control group will receive standard health education provided via a manual, and both groups will receive consistent perioperative Enhanced Recovery After Surgery care. The primary outcome will be the change in Barthel Index (a tool for assessing independence in activities of daily living) from baseline to 30 days postoperatively; secondary outcomes will include pain scores, disability, patient satisfaction, and the 30-day postoperative Comprehensive Complication Index. The trial will initiate recruitment in April 2026 and conclude in December 2027, aiming to evaluate the feasibility and efficacy of PHYSIO-Prehab and provide high-quality evidence for patient-centered perioperative care pathways in this population.

Occupational Exposure to Whole Body Vibration Among U.S. Military Veterans: Acute and Chronic Contributions to Musculoskeletal Disorders and Spine-Area Pain

Significance to VA: There is a lack of prospective longitudinal studies investigating the relationship between risk factors to Veterans and development and progression of musculoskeletal (MSK) spine injury and pain. Military operational exposure to whole body vibration (WBV) is known to contribute to MSK disorders and pain. Our preliminary studies identified accelerated lumbar and cervical spine degenerative changes in military fighter pilots and helicopter aircrew compared to age- and sex-matched civilian controls. Those changes were likely associated with WBV that military aircrew experience during flight training, primarily affected intervertebral discs (IVDs) and endplates, were associated with neck and back pain symptoms and reduced functional capacity, and are likely to lead to lifelong spine-related issues. Therefore, these aircrew, and other military personnel that experience occupational WBV, are likely to enter the VA Healthcare system with pre-existing degenerative changes and spine-related pain symptoms that can progress over time. Similarly, many Veterans enter civilian occupations that involve WBV such as truck drivers and heavy equipment operators that may also have detrimental effects to the spine and lead to spine-related pain. Development of informed interventions and treatment protocols requires a mechanistic understanding of how the spine is acutely and chronically affected by occupational WBV from both structural and physiological perspectives. Innovation and Impact: Novel multi-parametric application of noninvasive magnetic resonance imaging (MRI) techniques such as arterial spin labeling (ASL), T2\* decay from ultra short TE, and diffusion MRI can provide early objective indications of endplate degenerative state and IVD hydration and perfusion, and novel application of upright MR imaging allows for gravitational loading of the IVD while observing segmental and region IVD fluid distribution and transport patterns. Specific Aims: The goal of the proposed effort is to characterize the effects of previous military and current civilian occupational WBV on IVD and endplate health and degeneration (Aim 1), and segmental and regional IVD fluid distribution and transport differences (Aim 2). The endplates contain vasculature that permits IVD fluid exchange and may be linked to IVD fluid dynamics. We propose looking for connections between segmental and regional IVD fluid dynamics, degenerative state of the associated endplates, and WBV exposure (acute-controlled and longitudinal-occupational). Finally, we propose evaluating the impact of body hydration state on IVD fluid distribution and transport following acute (30 min) controlled WBV (Aim 3). Cumulatively, these results inform population-specific preventative measures to preserve endplate health for Veterans in occupations that present with WBV and identify potential areas for further research and targeted treatment of MSK disorders and MSK pain. Methodology: This study will explore acute and chronic changes to the structure and physiology of the spine by enrolling Veterans with prior military or current civilian occupation that involves daily WBV. Advanced MRI sequences will identify endplate sclerosis and physiological changes including disc hydration and perfusion. Acute effects of WBV will be assessed using pre/post MRI scans with experimental WBV. Path to translation/Implementation: Our existing relationships with VA clinicians, including spine surgeons, physical medicine and rehabilitation, and pain medicine, will ensure VA patient applicability of these findings and will help to translate any outcomes from this research and future studies directly into patient care.

Rate of Bone Union After Surgery With Stand-alone Fibergraft

Some people have back problems caused by degenerative conditions or instability of the spine (eg. Spondylolisthesis). These problems can lead to pain, nerve issues, or difficulties in walking. A common treatment is a type of back surgery called lumbar interbody fusion, which helps stabilize the spine. At the St. Maartenskliniek in the Netherlands, doctors have been using a special material called Fibergraft Bioactive Glass Putty for such surgeries since 2023. This material helps bones grow and heal, and it's placed inside the spine without needing extra bone from another part of the body. This study will look at how well this material works by evaluating how many patients' bones successfully healed after surgery using this material. It will also look at how patients feel and recover after the procedure

Evaluating the Efficacy of a Mobile Application in Postoperative Rehabilitation

This study aims to evaluate the effectiveness of a mobile application in improving postoperative rehabilitation outcomes among patients undergoing orthopedic surgery.

Proteomic and Histological Analysis of Ligamentum Flavum in Lumbar Stenosis

Background Lumbar spinal stenosis (LSS) is a common condition characterized by spinal canal narrowing, often linked to ligamentum flavum hypertrophy (LFH) and degeneration. Fibrotic processes involving elastin and collagen alterations contribute to LF thickening and spinal instability. Despite progress, the molecular mechanisms underlying LFH remain unclear, necessitating targeted diagnostic and therapeutic strategies. Objective This study aims to analyze the proteomic and histological changes in LFH associated with LSS, correlating molecular signatures with imaging and surgical findings to identify potential therapeutic targets. Methods LF samples from LSS patients undergoing surgery will be analyzed using mass spectrometry-based proteomics and histology to identify biomarkers and molecular pathways. Correlations between imaging, intraoperative findings, and molecular profiles will be assessed. Expected Results The study aims to identify specific biomarkers and molecular pathways involved in LFH, linking them to clinical and imaging findings. Statistical analyses will evaluate associations between molecular alterations and surgical outcomes to define therapeutic targets. Significance By identifying molecular markers of LFH, this research aims to improve LSS diagnosis and treatment, potentially guiding targeted therapies to slow disease progression and enhance patient outcomes. Study Design A multidisciplinary team from Fondazione Policlinico Universitario Agostino Gemelli and Università Cattolica del Sacro Cuore will conduct the study, ensuring robust data integration and statistical evaluation. Conclusion This comprehensive study will provide valuable insights into the molecular and histological modifications associated with LFH in LSS, paving the way for new therapeutic approaches to improve patient outcomes and satisfaction.

Strategic Use of Big Data in Spine Surgery - Testing Digital Prediction of Outcome in Clinical Praxis

The goal of this prospective, multicenter clinical trial is to determine if the use of the postoperative outcome prediction model the Dialogue Support tool can alter postoperative patient-reported outcome and satisfaction compared to current practice. The main questions it aims to answer are: * Does its use alter patient-reported outcome measured by general assessment regarding leg pain and Satisfaction in lumbar spinal stenosis? * Does its use alter patient-reported outcome as measured by general assessment regarding arm pain and Satisfaction in cervical rhizopathy? * How does the Quality of Life in patients - who after assessment by spinal surgeon do not proceed to surgery - compare with patients with the same baseline profile who did undergo surgery? Eligible participants will be presented with their predicted postoperative outcome generated by the Dialogue Support tool, as an adjunct to the ordinary assessment by a spine surgeon. Researchers will compare participants with a matched control group from the Swedish Spine Register ("Swespine") to see if the Dialogue Support tool can alter postoperative patient-reported outcome and satisfaction.

Risk Factors of Paraspinal Muscles in Degenerative Lumbar Spondylolisthesis

This is a retrospectively observational study. The goal of this observational study is to analyze the risk factors of paraspinal muscles associated with the occurrence of spondylolisthesis in patients with degenerative lumbar spondylolisthesis(DLS) and to construct a predictive model. The main question it aims to answer is: Which paraspinal muscle changes are risk factors for DLS? We will collect the information of patients who have undergone lumbar MRI in our hospital and have been diagnosed with back pain ( including spondylolisthesis or no spondylolisthesis) during the period from 2022 to 2024.The collected data included gender, age, body mass index (BMI), diabetes, hypertension, occupation and imaging parameters. We will then retrospectively analyze the risk factors associated with lumbar spondylolisthesis.

Spine Surgery Video Observation Study. The Creation of a Benchmark Video (RGB-Depth) Dataset to Investigate the Feasibility of Developing a Markerless Tracking System for Spine Surgery.

The primary study objective is to build a video dataset, consisting of both colour and depth information, of spine surgery that includes both 'open' and 'minimally invasive' (MIS) surgeries. Using accompanying preoperative CT scans of the patient's spine, we aim to develop a markerless tracking system for spine surgery, which the collected dataset will be used to both train, and then benchmark against.