Spondylosis

Researchers are evaluating the safety and effectiveness of the PerQdisc Nucleus Replacement Device NRD for patients with degenerative disc disease DDD causing chronic low back pain. This prospective, open-label, multi-center study involves 72 patients who have DDD in one or more lumbar discs between L1 and S1. The study aims to collect additional data on this minimally invasive device, which is designed to maintain disc height and preserve spinal motion compared to the current standard spinal fusion surgery. Participants will undergo nucleus replacement surgery using the PerQdisc device via standard anterior, lateral, or minimally invasive posterolateral surgical approaches to replace the single nucleus pulposus in the affected lumbar disc. All surgeries require approval from a Medical Advisory Board. The study focuses on patients who have exhausted at least six months of conservative treatments for their back pain and meet specific criteria, including disc height and pain scores. During the study, participants will be monitored closely with evaluations at multiple time points up to five years. Researchers will assess performance outcomes such as disability Oswestry Disability Index, pain levels Visual Analog Scale, disc height, and range of motion, as well as safety outcomes including device expulsion, failure, neurological status, revision surgeries, and serious adverse events. Follow-up visits will include questionnaires, imaging, and clinical assessments to track the devices impact over time.

Researchers are evaluating the use of high-resolution 7 Tesla MRI imaging of the spine to better distinguish bone spurs from disc material and to more clearly show compressed nerves in the neuroforamen compared to standard 3 Tesla MRI. This study aims to provide surgeons with detailed anatomical images before surgery, potentially reducing the need for CT scans when bone anatomy is crucial. Participants undergo a 7 Tesla MRI scan of the spine, which is a diagnostic imaging procedure. The study compares the 7 Tesla MRIs ability to differentiate compressed nerves with that of the 3 Tesla MRI over a two-year period. This observational study does not involve treatment but focuses on imaging evaluation. During the study, participants will have MRI scans and may provide informed consent for participation. Researchers will assess imaging details to measure how well the 7 Tesla MRI depicts nerve compression compared to standard imaging. The primary outcome is the differentiation of compressed nerves in the neuroforamen over two years. Participants involvement length and visit frequency depend on the imaging schedule and clinical needs.

Researchers are evaluating a combined lifestyle intervention integrated into standard care for patients with persistent low back pain LBP who are overweight or obese and referred back to primary care from the hospital. The study aims to improve physical functioning and physical activity over 36 months, while also reducing healthcare and societal costs. Lifestyle factors like physical inactivity, stress, sleep quality, excess weight, and diet are addressed because they contribute to LBP and related health risks such as diabetes and cardiovascular disease. The intervention is delivered by certified physioexercise therapists following Dutch clinical guidelines. It includes a two-year program where the first six months focus on behavioral change, and the next 18 months focus on maintaining new healthy habits. The program uses group and individual sessions with techniques such as motivational interviewing and self-monitoring. Patients set their own goals and treatment is tailored to their lifestyle risks and LBP clinical factors. The comparison group receives usual care as prescribed by medical specialists, which may include education, exercise therapy, pain medication, or referral back to primary care. Participants will attend scheduled assessments at baseline and multiple follow-up points over 36 months. Researchers will measure physical activity using a device that tracks daily steps and assess physical functioning with a disability questionnaire. Additional evaluations include pain intensity, weight, sleep quality, diet, inflammation markers, quality of life, healthcare costs, and overall perceived effect. These measurements will help determine the effectiveness and cost-effectiveness of the combined lifestyle intervention compared to usual care in this patient group.

Researchers are evaluating a new way of providing physical therapy directly in the emergency department ED for adults with low back pain. This multi-site feasibility trial compares this embedded ED physical therapy model to usual care at two hospital EDs within the Northwestern Medicine and University of Utah Health systems. The study aims to test if this approach can be successfully implemented, including enrolling patients and collecting long-term outcome data, as a step toward a larger future trial focused on pain and opioid use outcomes. The trial randomly assigns two hospital EDs to either have a physical therapist available on-site to start timely care for low back pain patients or to continue with usual care, which may include imaging, education, and medications but no ED physical therapist involvement. The intervention period lasts 9 months, followed by 12 months of collecting patient-reported outcomes and electronic health record data. A third hospital ED will contribute baseline data without participating in the intervention or enrollment. Participants are adult patients visiting the ED with low back pain lasting up to 30 days during daytime hours. They will complete surveys over 12 months to measure pain interference and other health outcomes. Researchers will also review health records and survey clinicians to assess how well the intervention is adopted and delivered. The study monitors participant retention and data completeness to inform future research. Overall participation lasts 21 months, including intervention and follow-up phases.

Low back pain is a leading cause of disability worldwide and a common reason for primary care visits. This research aims to improve how low back pain is managed in primary care by testing a multilevel intervention developed with general practitioners, physiotherapists, and occupational therapists. The study evaluates the effectiveness of this new care approach compared to usual care, focusing on cost-effectiveness, imaging rates, and patient disability over time. The intervention includes training general practitioners, sending reminders, providing patient education, and using a clinical pathway based on risk of chronicity. Patients may receive education and self-management support, individual physiotherapy sessions after a specialized two-day workshop, and multidisciplinary group management if needed. Care pathways involve screening, follow-up questionnaires assessing risk and work ability, and tailored treatment steps over several weeks, with coordination among healthcare providers encouraged. Participants will be monitored for 12 months through questionnaires at multiple time points and administrative data. Outcomes measured include back-related disability, imaging referrals, opioid and sick leave prescriptions, pain intensity, quality of life, work participation, and beliefs about back pain. Healthcare professionals confidence and beliefs will also be assessed. Implementation outcomes such as acceptability and feasibility will be explored via interviews and focus groups with patients and practitioners to understand integration into routine care.

Degenerative Cervical Myelopathy DCM is an age-related condition mainly affecting people aged 50 and over, caused by changes in the spine like ligament ossification or disc problems that compress the cervical spinal cord. It leads to symptoms such as hand numbness, clumsiness, and difficulty walking. This research aims to develop new surgical criteria based on physical performance tests alongside MRI and clinical signs to better guide surgery decisions for DCM, focusing on the Chinese population. The study involves confirming DCM diagnosis using MRI and orthopedic surgeon evaluation. Researchers will use physical performance tests such as the 10-second Grip and Release test, 10-second Stepping Test, and Foot Tapping Test over 24 months to assess functional deficits. These tests, combined with clinical indicators and MRI findings, will help establish objective criteria to predict the need for surgery. Participants will be evaluated regularly for their physical abilities and neurological function using these performance tests. The study will monitor changes over 24 months to assess hand and gait coordination. Researchers will also use clinical signs and patient cognitive ability to understand symptom progression. The goal is to improve surgical decision-making and recovery outcomes by identifying clear physical performance benchmarks in DCM patients.

The trial investigates the real-world use of INFUSE174 Bone Graft for patients in Korea who require lumbar fusion surgery due to degenerative disc disease. It is a prospective, observational, multi-center post-market surveillance study designed to collect data on the safety and effectiveness of this commercially available device used as intended. The study aims to follow over 600 cases during a four-year period after approval in Korea. Participants in this study are patients treated with INFUSE174 Bone Graft via anterior ALIF or oblique OLIF lumbar interbody fusion techniques. The device is approved for use as a substitute for autogenous bone graft in patients with degenerative disc disease who have undergone at least six months of nonoperative treatment. The study observes patients who have received this device according to standard care without altering their treatment. During the study, patients will be monitored for at least 12 months after surgery. Researchers will collect information about any adverse device effects and assess fusion status within this period. Clinical outcomes such as disability index ODI, pain levels VAS, and neurological success will be recorded at multiple timepoints including 6 weeks, 3 months, 6 months, and 12 months after surgery. This comprehensive follow-up aims to provide important real-world data on patient recovery and device performance.

This trial investigates the safety and effectiveness of Intradiscal Cell Therapy IDCT compared to a Sham procedure for adults aged 18 to 75 with mild to moderate symptomatic degenerative disc disease at a single lumbar level L3-S1. The study is a Phase III, randomized, double-blinded, sham-controlled, multicenter trial involving 162 participants. The target disc is identified by imaging and must meet specific grading criteria, with participants experiencing chronic low back pain unresponsive to conservative treatments. Participants will be randomly assigned in a 21 ratio to receive either a single intradiscal injection of 9 million cells in 1 mL IDCT or a Sham needle insertion up to the annulus of the target disc. The target disc is one of L3L4, L4L5, or L5S1. Randomization occurs 7 to 14 days before treatment. The study includes a 52-week primary evaluation period followed by an additional 52-week follow-up, totaling 104 weeks for monitoring. Throughout the study, participants will undergo baseline and follow-up assessments including MRI and X-ray imaging, Visual Analogue Scale VAS for low back pain, Oswestry Disability Index ODI, and other health and disability questionnaires. Adverse events and treatment safety will be tracked from Day 1 through Week 104. Researchers will also measure disc volume, pain medication use, and treatment failure rates while participants adhere to study protocols and visit schedules over two years.

This research aims to observe and compare the outcomes of patients undergoing anterior cervical discectomy and fusion ACDF for degenerative disc disease. The study looks at two types of procedures one using a device called Tritanium C and the other using structural allograft bone with plates. It is a combined observational study including both retrospective and prospective data collection to evaluate fusion success and adverse events. The study involves two groups a retrospective cohort of up to 40 patients who previously received ACDF with structural allograft bone and plates, and a prospective group of 20 patients receiving Tritanium C as part of their standard care. Data includes patients treated at one or two contiguous cervical spine levels. The retrospective group will be matched to the prospective patients in a 21 ratio. Both cohorts have follow-up visits and imaging at baseline, 6 months, and 12 months post-operation to assess fusion and other outcomes. Participants will have clinical assessments including neck disability, neck and arm pain, and neurological status at baseline and during follow-up visits at 3, 6, and 12 months post-operation. Researchers will collect imaging and questionnaire data to measure fusion success and adverse events over time. The total participation period for retrospective patients includes up to one year of follow-up, while prospective patients are monitored through their standard care schedule. The study is conducted without blinding or randomization.

Researchers are evaluating a new way to provide preoperative information to patients who are candidates for spinal or urological surgery. This study is an interventional, randomized controlled trial conducted at multiple centers. It aims to compare a new multimedia-based method that objectively checks patient understanding against the standard informed consent process to see which better supports patient decision-making about surgery. Participants in the experimental group will receive detailed information through videos with surgical options, graphics, and animations. They will also have interviews with the surgeon and caregivers using 3D-printed models to guide shared decision-making. After deciding on surgery, patients will join educational programs to reinforce understanding before a final surgeon interview and signing of informed consent. The control group will receive the usual care, including a standard explanatory interview and consent signing. Throughout the study, participants will complete questionnaires assessing satisfaction, comprehension, mental health, pain, disability, urinary and sexual function, and legal outcomes at multiple time points before surgery, at discharge, and at two and six months after surgery. The research team will monitor these measures to evaluate the impact of the new method on patient understanding and decision satisfaction over time.