Spinal stenosis is a condition characterized by the narrowing of spaces within the spine, which can put pressure on the nerves. Clinical trials for spinal stenosis explore a variety of approaches, including treatment evaluations aimed at improving mo...
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Found 203 Actively Recruiting clinical trials
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Researchers are evaluating a new therapy approach called MOBILE to improve walking ability in children and teens with Cerebral Palsy. This study aims to find out if the therapy is acceptable and helpful to both the children and their families when provided in a community setting. The key questions include whether participants tolerate the therapy, if families find it manageable, and if children complete all therapy sessions and assessments as planned over the course of the study. The therapy uses motor learning principles to target each child's specific walking goal. Participants will complete a total of 30 hours of therapy over 6 weeks, with at least 24 hours conducted in a clinic. The remaining hours can be done through a home program. This flexible format allows children to choose how they complete their therapy sessions while focusing on improving their walking patterns. During the study, children will be assessed before and after therapy to see if they meet their walking goals. Researchers will also interview participants about their experience with the therapy. Various outcome measures will be tracked over 2 years, including recruitment, adherence, retention, adverse events, fidelity to the intervention, and the acceptability of the therapy. Functional walking tests and quality of life assessments will be done at baseline, post-intervention, and at a 3-month follow-up. Participants are involved in therapy sessions, assessments, and interviews throughout the study period.
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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.
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Researchers are evaluating post-operative management approaches after a modified Lapidus arthrodesis surgery for hallux valgus, with or without additional surgeries such as Akin or Weil/Hohmann procedures. The study aims to compare the effectiveness and safety of immediate full weight-bearing versus partial weight-bearing (10-15 kg) during rehabilitation. This randomized controlled trial explores a new rehabilitation method following foot surgery to improve recovery. Participants will be randomly assigned to one of two groups after surgery: one group will follow partial weight-bearing with a specialized VACOPASO shoe and use crutches along with antithrombotic medication for 6 weeks, while the other group will have immediate complete weight-bearing with the same shoe and medication for the same period. The surgical operation follows standard clinical practices for hallux valgus correction. During the study, healing progress will be monitored through standard X-rays at 6, 12, and 24 weeks to check bone healing, hardware fixation, and fracture alignment. Pain will be measured using a Visual Analogue Scale at the day of surgery and at follow-up visits. Quality of life and functional recovery will be assessed through established foot and ankle scoring systems at multiple time points. The main outcome is the subjective functional recovery measured by the Olerud and Molander Ankle Score at 6 weeks post-surgery.
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Researchers are investigating the use of ABM/P-15 bone graft compared to traditional bone graft in patients undergoing surgery for Adult Spinal Deformity (ASD). This study aims to improve clinical outcomes by promoting faster bone healing, reducing the need for additional surgeries, minimizing complications, and improving health-related quality of life. The trial is a prospective, randomized, controlled clinical study conducted at a specialized spine unit. Participants are randomly assigned to receive either the ABM/P-15 bone graft, which is a device combining anorganic bovine bone mineral with a synthetic peptide to enhance bone growth, or a standard bone graft made from locally harvested bone mixed with morselized allogenic femoral head. Both graft types are used during posterior spinal instrumentation and fusion surgery, with anterior support added as needed. The ABM/P-15 bone graft is placed on the spine structures and contained by the surrounding muscle. The study includes preoperative planning, surgery, and follow-up evaluations up to two years. Participants complete questionnaires before surgery and at 3 months, 1 year, and 2 years after surgery. They undergo X-rays at multiple time points and a CT scan one year after surgery to assess bone fusion and detect pseudarthrosis. Researchers track revision surgeries, adverse events, and cost-effectiveness during the study. Data on surgical details, complications, medication use, and rehabilitation are collected from medical records. The total participation lasts about two years, allowing for detailed assessment of outcomes and safety.
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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.
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Lumbar spinal stenosis (LSS) is a common age-related condition causing low back pain, poor balance, and reduced activity, which significantly lowers quality of life. This research aims to study how decompressive surgery affects activity levels in elderly patients with symptomatic LSS. The study addresses gaps in understanding the surgery's impact on physical activity, beyond known improvements in pain and disability. Participants in this observational study will undergo decompressive surgery for lumbar spinal stenosis. Activity levels will be measured before surgery and at 3, 6, 12, and 24 months after surgery using accelerometers, which provide detailed activity data. This long-term follow-up allows researchers to observe changes in physical activity over two years. During the study, participants' physical activity, inactivity, quality of life, functional disability, and self-reported activity will be regularly assessed. These evaluations will use objective device measurements and questionnaires. The study will monitor changes from before surgery through the two-year follow-up to understand how surgery influences activity and well-being in elderly LSS patients.
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Researchers are evaluating functional activity and stability in adult patients with degenerative thoracolumbar spinal deformity who are undergoing surgery. The study aims to measure changes in movement and trunk stability using motion analysis and accelerometer devices to better understand patients' physical function after spinal deformity correction surgery. Participants will be assessed in the Motion Analysis Laboratory at Mayo Clinic Rochester. They will also wear triaxial accelerometers placed on the waist, thigh, and both ankles to monitor physical activity in their daily living environment for four consecutive days. The accelerometers are worn during waking hours and removed during sleep, showering, and swimming. Assessments will be done at baseline, 6 to 12 weeks post-surgery, and one year after surgery. During the study, participants will undergo motion analysis tests at the lab to measure changes in function, gait, and trunk stability over time. Activity monitoring with the accelerometers captures real-world movement data. Follow-up evaluations at multiple time points allow researchers to track recovery and physical activity levels. The total study duration for each participant includes assessments up to one year after surgery.
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This research aims to create a pediatric robotic spine surgery registry to collect and analyze data on the combined use of robotics and navigation, along with patient-specific rods, in surgeries for pediatric spine deformities. The study includes patients diagnosed with various spine deformities such as idiopathic scoliosis, adolescent idiopathic scoliosis, spondylolisthesis, congenital scoliosis, and neuromuscular scoliosis. The goal is to establish an educational and informative framework for this technology across participating institutions. Participants will undergo standard-of-care spine deformity surgery that uses robotics coupled with navigation and/or patient-specific rods. The study focuses on observing these surgeries without introducing experimental treatments. Data will be gathered during surgery and at follow-up intervals to assess surgical precision and outcomes. During the study, researchers will track the precision of pedicle screw placement within 2 mm of cortical breach during surgery. They will also measure radiation exposure to patients and surgeons, operative time, blood loss, and total operative cost. Participants will complete several questionnaires at baseline, 6 months, 1 year, 2 years, and 5 years to evaluate physical activity, emotional distress, pain interference, peer relationships, and quality of life. The study follows participants for up to five years to monitor improvements in spine alignment and other health outcomes.
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This research aims to understand how the length of time patients experience symptoms affects the results of lumbar spine surgery. It focuses on people with conditions such as degenerative disc disease, spinal stenosis, spondylolisthesis, and disc herniation who have not improved after 3 to 6 months of conservative treatment. Surgery is considered when neurogenic claudication and positive imaging findings are present, with previous studies showing surgery can improve disability and pain for at least four years compared to conservative care. The study includes patients undergoing lumbar spine surgery for symptoms like lower back pain, radiculopathy, neurogenic claudication, leg weakness, and bowel or bladder issues. There is one study group consisting of these patients who will have surgery. The trial does not involve a comparison group or placebo, as it is observational and focuses on monitoring outcomes after surgery. Participants will be followed for at least six months after surgery. Researchers will assess disability, pain levels, musculoskeletal conditions, and patient satisfaction at this time. Data will be collected to evaluate how symptom duration before surgery relates to these outcomes. The study is sponsored by Kafrelsheikh University and plans to start in July 2025 and end in January 2026.
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This research aims to evaluate the clinical outcomes of endoscopic lumbar decompression surgery performed in an outpatient setting for patients over 75 years old. The study focuses on elderly individuals with spinal pathologies, investigating less invasive endoscopic techniques to reduce operative risks and shorten hospital stays, addressing challenges linked to traditional surgeries in this age group. It is a prospective, multicenter, non-interventional study assessing the biportal and uniportal endoscopic approaches' feasibility and effectiveness in this population. The treatment involves endoscopic lumbar decompression surgery using either biportal or uniportal methods, specifically performed as outpatient procedures to minimize surgical trauma and preserve lumbar spine function and stability. Patients will undergo surgery on one lumbar level, with the study observing the outpatient care process without additional interventions. The study is non-interventional and collects data through questionnaires and clinical evaluations. Participants will be followed for three months after surgery to monitor clinical progress, including any complications or hospital readmissions. Data collection includes clinical exams, quality of life assessments, medical histories, ongoing treatments, and self-administered questionnaires. The primary outcome measures the success of outpatient care by tracking hospitalizations or readmissions, while secondary outcomes assess treatment safety and efficacy during inclusion and follow-up visits.
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