Clinical Research Directory

Phase II Cohort of Spinal Stereotactic Radiotherapy in Patients Using a MR LINAC

To learn whether giving spinal stereotactic radiosurgery (SRSS) that uses a more advanced imaging scan method called Magnetic Resonance imaging with a Linear Accelerator (MR-LINAC) during treatment will lead to improved responses to treatment and better quality of life. SRSS is radiation therapy given to the area around your spine.

Influence of Lidocaine Infusion on Motor Evoked Potential Thresholds

The purpose of this study is to determine the effect of lidocaine infusion on intraoperative neuromonitoring in patients undergoing spine surgery.

OssiMend BA in Posterolateral Instrumented Lumbar Fusion

The primary objective of this study is to measure the success rate of lumbar fusion in subjects at 12 months when instrumented lumbar arthrodesis is performed using OssiMend Bioactive Moldable as the bone grafting material

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.

A Pilot Study on App-based Treatment Combining Physical Exercise, Graded Activity, and Pain Journaling for Patients with Spinal Complaints

Background: The prevalence of spinal complaints such as low back pain is rising due to factors like aging, sedentary lifestyle, and obesity. Traditional conservative treatments include physical therapy and lifestyle modifications. The digital revolution in healthcare has introduced app-based interventions as a promising alternative. Rationale: Given the high burden of spinal complaints and the associated economic impact, there is need for effective and efficient treatment modalities. This is especially evident in Western healthcare systems with growing demands and limited resources due to the changing demographic of the population. An app-based approach offers a viable solution by combining evidence-based conservative treatments. Moreover, an app-based treatment could offer personalized treatment, real-time feedback, and enhanced patient engagement at lower costs, presents as a viable solution. Objective: This pilot study aims to evaluate the efficacy of an app-based treatment method combining physical exercise, graded activity, and pain journaling for patients with spinal complaints who will otherwise receive physical therapy, general lifestyle advice, or an expectant treatment in current practice. Study design: Single center prospective study. Study population: A total of 30 patients over 18 years old suffering from spinal complaints for which in current practice physical therapy, general lifestyle advice, or an expectant treatment will be advised. Intervention: An app-based treatment consisting of a combination of physical exercise, graded activity, and pain journaling. Main study parameters/endpoints: Primary endpoint: Patients' experience and satisfaction qualitatively, measured using semi-structured face-to-face interviews after three months of treatment. Secondary endpoints: Quality of Life (Qol) measured with the EuroQol 5 dimensions (EQ-5D-5L) at baseline, one, two and three months after starting the intervention. Change in back- and leg-pain, measured with the Visual Analogue Scale (VAS). Change in disability, measured with the Oswestry Disability Index (ODI). Change in catastrophizing of pain, measured with the Pain Catastrophizing Scale (PCS). Change in lost productivity, measured with patient reported missed working days. Healthcare consumption, measured with number of visits to doctor or paramedic. Change in Body Mass Index, measured using patients' input on length and weight. Adherence of participants measured using frequency of patients' input in the mobile application. Safety measured using the (serious) adverse events ((S)AE). Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The nature and extent of the burden associated with participation in the app-based treatment program primarily involve adherence to recommended activities and inputting relevant health data. Given that the investigators are integrating existing treatment modalities, such as physical exercise, graded activity, and pain journaling, the risks associated with participation are minimal, as these interventions are already deemed safe and widely practiced. The responsibility for determining each patient's suitability for participation in this study lies with the referring physician. Participants can expect benefits such as improved pain management, enhanced physical function, and better overall well-being.

Gait Analysis and Degenerative Spine

The goal of this observational study is to analyse the biomechanics of a degenerative spinal disease. The main questions it aims to answer are: * What are the biomechanical variables affected by the disease * How they evolve with disease progression and treatment

Gene Expression Profiles in Spinal Tuberculosis.

Tuberculosis (TB) is one of the top ten causes of death worldwide with approximately 10 million cases globally and 1.2 million deaths. Sub-Saharan Africa carries the highest burden of TB. South Africa has one of the highest HIV and TB rates worldwide with an HIV prevalence rate in adults of 19% and a TB case notification rate of 615/100,000 in 2019. Over many years, focus has been paid to pulmonary TB and extrapulmonary TB (EPTB) has received only little attention even though it accounts for almost a quatre of all TB cases. The diagnosis of EPTB remains challenging simply because sample collection requires invasive procedures in the absence of a blood-based diagnostic test. Spinal TB (spondylitis or spondylodiscitis caused by Mycobacterium tuberculosis) - often known as Pott's disease - accounts for up to 10% of EPTB and affects young children, people with HIV-coinfection and elderly, and often leads to lifelong debilitating disease due to devastating deformation of the spine and compression of neural structures. Little is known with regards to the extent of disease and isolated TB spine as well as a disseminated form of TB spine have been described. The latter presents with a spinal manifestation plus disseminations to other organs such as the lungs, pleura, lymph nodes, the GIT or urinary tract or even the brain. In the Spinal TB X cohort, the investigators aim to describe the clinical phenotype of spinal TB using whole body PET/CT and identify a specific gene expression profile for the different stages of dissemination and compare findings to previously described signatures for latent and active pulmonary TB. A blood-based test for spinal TB would lead to earlier diagnosis and treatment in all settings globally and improve treatment outcome of this devastating disease.

Fecal Microbiota Transplantation in Axial Spondyloarthritis

Although biologic therapy have revolutionized the treatment of Spondyloarthrtitis (SpA), many patients do not experience complete relief of SpA related complaints. It has been established that patients with SpA have an altered composition of microorganisms (microbiota) in the gut compared to healthy controls, and that this correlates to disease activity and respons to therapy. The goal of this randomized double-blind study is to evaluate the efficacy of fecal microbiota transplantation (FMT) in patients with axial SpA with a suboptimal effect of biologic therapy. The main questions it aims to answer are: * Can FMT reduce disease activity in axial SpA? * Can FMT alleviate pain and reduce fatigue in axial SpA? * Is the composition of microorganisms restored to normal in patients with SpA after a treatment with FMT? Participants will receive a single treatment in the form of an enema with either donor FMT or placebo at baseline. The primary endpoint will be evaluated after 90 days, but efficacy and safety will be monitored from baseline until 365 days.

Stronger Together Global Registry

A global, prospective, non-randomized, multicenter, observational, post-market, medical record review registry evaluating real-world evidence for SeaSpine products.