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Found 10 Actively Recruiting clinical trials

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Actively Recruiting

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.

Age: 75Years +All Genders
4 locations
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Actively Recruiting

Researchers are comparing dual-mobility DM cups versus unipolar UP cups for people undergoing primary total hip arthroplasty THA using the direct anterior approach. THA replaces damaged bone and cartilage with prosthetic parts, and while UP cups are common, they carry risks of dislocation, especially in elderly or female patients and those with lumbar stiffness or femoral neck fractures. DM cups were designed to reduce dislocation rates by allowing more movement and stability, but concerns about complications like polyethylene wear and impingement exist. This trial aims to see if DM cups provide outcomes that are not worse than UP cups, focusing on hip joint awareness. Participants will have THA through the direct anterior approach with liners made of highly-crosslinked vitamin-E infused polyethylene and femoral heads made of metal or ceramic. Those randomized to the DM cup group will receive a cementless dual-mobility cup, while those in the UP cup group will receive a cementless unipolar cup. The femoral stem will be cemented in female patients aged 75 or older or those diagnosed with osteoporosis. The surgery involves specific muscle dissection and femoral neck osteotomy before implanting the prosthetic components and closing the surgical site. During the study, participants hip function, pain, sports and sexual activity, satisfaction, and adverse events will be assessed before surgery and at 3 months, 1 year, and 2 years after surgery. The main outcome is the forgotten joint score measured at 2 years. Researchers will monitor for complications and compare results between the two groups. The study will last until 2030, with ongoing follow-up to evaluate patient outcomes and safety.

Age: 18Years +All GendersPhase Not Applicable
1 location
S

Actively Recruiting

Researchers are investigating the use of endoscopic surgery as a less invasive alternative to traditional lumbar spine fusion for patients with spinal stenosis and spondylolisthesis. This approach aims to decompress the lumbar spine while preserving its natural function and stability, potentially reducing the need for spinal fusion. The study explores whether endoscopic techniques can lower the rate of more invasive surgical interventions in this population. The study focuses on patients who require spinal decompression surgery and are considered for endoscopic procedures. It observes outcomes related to these minimally destructive surgical methods without introducing experimental drugs or devices. The main goal is to evaluate the rate of surgical reintervention within one year after the initial endoscopic surgery. Participants will be monitored over time to assess if further surgical procedures are needed. Researchers will review medical imaging and clinical data to understand the effectiveness of endoscopic decompression in avoiding fusion surgery. The study involves adults 18 years and older and tracks outcomes related to surgical reintervention during the follow-up period, with participation potentially lasting up to several years.

Age: 18Years +All Genders
13 locations
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Actively Recruiting

This research focuses on adolescent patients aged 12 to 20 years with idiopathic scoliosis who require surgical treatment but face a waiting period of six months or more. The study aims to identify factors that predict improvement in quality of life following surgery, which is important for understanding patient outcomes after scoliosis correction. Participants will not receive any experimental treatment but will complete several quality of life questionnaires such as the SRS-22r, SF-36, TAPS, and KIDSCREEN10. These behavioral assessments are used to gather information on health and well-being before and after surgery. Throughout the study, patients will be observed with a focus on changes in their quality of life one year after surgery, measured primarily by the SRS-22r score. Participants and their legal representatives will be informed about the study, and the research includes monitoring and evaluating patient responses to surgery over time.

Age: 12Years - 20YearsAll Genders
1 location
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Actively Recruiting

This research focuses on adults with bilateral traumatic amputation of both forearms, a rare condition that greatly affects independence and quality of life. The study evaluates two approaches bilateral hand and forearm allografts transplants and the use of prosthetic forehands. It aims to compare these options in terms of costs, quality of life, usefulness, satisfaction, autonomy, and social integration. The study builds on previous work that demonstrated the feasibility and functional benefits of bilateral hand grafts, despite the need for immunosuppressive treatment and potential medical complications. Participants receive either a bilateral allograft of the hands and forearms or prosthetic forehands. The transplant group must meet specific medical and psychological criteria, including a minimum of three months since amputation and no recent cancer history. The prosthetic group uses prosthetic devices for limb replacement. This non-randomized study conducted by Hospices Civils de Lyon compares these two treatment approaches over a 36-month period. During the study, researchers will monitor treatment costs over 36 months as the primary outcome. Participants will be assessed for quality of life, autonomy, satisfaction, and social integration. Medical evaluations include psychological assessments, kidney function, heart function, and blood pressure control for the transplant group. The study runs until October 2031, and participants will be regularly evaluated to understand the long-term impact and benefits of each treatment option.

Age: 18Years - 60YearsAll GendersPhase Not Applicable
11 locations
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Actively Recruiting

Researchers are studying adults with spinal deformity who have undergone surgery to understand what factors predict an improvement in their quality of life one year after the operation. This observational study focuses on patients with specific spinal deformity characteristics, aiming to identify key elements linked to better recovery outcomes. The study involves assessing participants using quality of life questionnaires such as the Oswestry Disability Index, Scoliosis Research Society-22R, and Short Form 36 Health Survey Questionnaire. Participants also undergo spinal radiography in full, face, and profile views. These assessments help track physical and functional changes related to the spinal deformity and surgery. Participants will be followed for up to 15 years, with researchers measuring factors associated with improvement in the Oswestry Disability Score over time. Throughout the study, participants complete questionnaires and have imaging tests to monitor their progress. The study sponsor is Elsan, and the total participation duration may extend over many years to gather long-term data on recovery and quality of life.

Age: 18Years +All Genders
1 location
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Actively Recruiting

Researchers are evaluating the safety and performance of the Hexanium TLIF system in treating adults with degenerative disc disease, a condition where spinal discs break down. This observational, international study includes patients who have already received or plan to receive the Hexanium TLIF implant. The study aims to follow participants for up to 24 months to collect important safety and effectiveness data. The treatment involves a Transforaminal Lumbar Interbody Fusion surgery, which fuses two vertebrae in the lower spine by removing the damaged disc and placing a cage to restore height, secured with screws and rods. Data will be collected from patients both retrospectively and prospectively at 2, 6, 12, and 24 months after the implant surgery to assess outcomes. Participants will be asked about their back and leg pain levels, disability, and any adverse effects since surgery. Researchers will measure fusion success, pain scores using the Visual Analogue Score VAS, disability with the Oswestry Disability Index ODI, and record any revision surgeries. The primary focus is on serious device- or procedure-related adverse events and changes in disability over one year. Follow-up spans two years to monitor long-term safety and performance.

Age: 18Years +All Genders
6 locations
S

Actively Recruiting

Researchers are evaluating the safety and performance of three Spinevision posterior fixation systemsLumis, Plus, and Ulisfor treating patients with thoracolumbar spinal degenerative conditions, including degenerative disc disease. This observational study includes both patients who have already received one of these implants and those planned for treatment, aiming to understand outcomes up to 24 months after surgery. The study follows participants who have undergone pedicle fixation surgery, a procedure supporting spinal fusion or correcting deformities from the thoracic spine to the sacral spine. Data collection occurs at key timepoints before surgery, during surgery, and post-operatively at 2, 6, 12, and 24 months. The focus is on assessing pain levels, disability, fusion success, and any adverse events related to the device or procedure. Participants will be asked about their back and leg pain using the Visual Analogue Score VAS, disability through the Oswestry Disability Index ODI, and any complications or need for revision surgery. These assessments help measure the devices safety and effectiveness over two years. The study also monitors for serious and non-serious device- or procedure-related adverse events throughout the follow-up period.

Age: 18Years +All Genders
3 locations
S

Actively Recruiting

Healthy Volunteer

Researchers are investigating how combining non-invasive brain and spinal cord stimulation during cognitive-motor tasks might improve sensorimotor and cognitive functions after neurological injuries like cervical spinal cord injury and stroke. This study also aims to assess how anatomical MRI, functional MRI, and neurophysiological tests can help optimize and predict the effects of these stimulation techniques. The study is a Phase 2, single-center, randomized, crossover, single-blind clinical trial involving control participants and those with neurological injuries. Participants will receive four different neuromodulation interventions transcranial direct current stimulation tDCS, transcutaneous spinal cord stimulation tSCS, a combination of tDCS and tSCS, and a sham placebo stimulation. Each intervention lasts 20 minutes and is administered during a cognitive-motor training task using the Armeo upper limb rehabilitation exoskeleton. Participants with spinal cord injury or stroke will complete nine visits, including inclusion, testing, and intervention visits, while control participants attend only inclusion and testing visits. Throughout the study, participants will undergo neurophysiological tests and clinical performance evaluations immediately after each intervention session. Outcome measures include sensory performance, hand grasping ability, cognitive function, safety, and feasibility of the interventions. Neurophysiological assessments will also be conducted to measure reflex responses. The study lasts several weeks with visits scheduled on specific days to monitor the immediate effects of each intervention.

Age: 18Years +All GendersPhase 2
2 locations
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Actively Recruiting

Researchers are evaluating the use of a fixed dose of 3.66 mcg of follitropin delta Rekovelle to stimulate the ovaries during intrauterine insemination IUI in women with infertility. The study aims to optimize ovarian response by promoting the development of two follicles, which may improve the chances of pregnancy while minimizing the risk of multiple pregnancies and treatment complications. This phase 2 study builds on previous findings supporting follitropin deltas use in assisted reproductive techniques like IVF and ICSI, focusing on patients with regular menstrual cycles and normal ovulation. Participants will begin ovarian stimulation with Rekovelle on day 4 of their natural menstrual cycle, continuing stimulation for up to 13 days. Regular monitoring using ultrasound and blood tests will track follicle development. When two mature follicles are identified, ovulation will be triggered with an hCG injection, followed by insemination 24 to 36 hours later. The study includes initial screening and consent visits, monitoring visits every two days starting on day 9 of stimulation, and follow-up visits 6-8 and 13 weeks after insemination. During the study, researchers will assess ovarian response by measuring the percentage of cycles with two mature follicles at ovulation trigger and track various hormonal levels, pregnancy rates, cycle cancellations, and pregnancy outcomes. Participants will undergo ultrasound scans and blood sampling for hormone levels, with safety monitored over nine months. The overall goal is to achieve pregnancy more quickly with fewer complications, providing a more comfortable treatment experience while carefully tracking all outcomes and any adverse events.

Age: 18Years - 38YearsFEMALEPhase 2
5 locations