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Found 11 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are evaluating the clinical outcomes of endoscopic lumbar decompression surgery performed in an outpatient setting for patients over 75 years old. This prospective, multicenter, non-interventional study focuses on the feasibility and effectiveness of biportal and uniportal endoscopic techniques to reduce operative morbidity and hospitalization time in elderly patients with spinal pathologies. The study addresses the challenges of traditional lumbar decompression surgery, which often involves longer hospital stays and higher risks for this age group due to comorbidities and bone fragility. The treatment involves endoscopic lumbar decompression surgery using either biportal or uniportal methods, performed as outpatient procedures to minimize surgical trauma and preserve lumbar spine function and stability. Patients will receive the surgery on one spinal level as indicated for their condition. The study does not intervene beyond standard care but collects data through questionnaires administered by the surgeon, including assessments of patients' autonomy in daily activities. Participants will be followed for three months after surgery, with evaluations including clinical examinations, quality of life assessments, medical history reviews, and self-administered questionnaires. Follow-up visits will collect information on clinical progress, imaging results, therapeutic interventions, and medication use to monitor recovery and identify any complications. The primary outcome measured is the number of patients requiring conventional hospitalization or readmission after surgery within the three-month period.

Age: 75Years +All Genders
4 locations
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Actively Recruiting

The trial investigates spinal conditions such as spinal stenosis and spondylolisthesis, focusing on reducing the need for lumbar fusion surgery. It evaluates the use of endoscopic techniques for decompressing the lumbar spine, aiming to preserve its natural stability and function. This approach is considered a less invasive alternative to traditional surgical methods, with the hypothesis that it can lower the frequency of more extensive spinal fusion procedures. The study centers on endoscopic decompression procedures as a treatment option for patients with specific lumbar spine pathologies. These minimally invasive surgeries are designed to be optimized and cause less tissue damage. Participants are patients who have spinal conditions requiring surgical intervention, including those with complications such as lumbar scoliosis or degenerative spondylolisthesis. The endoscopic approach is assessed as a potentially effective way to avoid lumbar arthrodesis. Participants will be monitored primarily for the need for any additional surgical interventions within one year after treatment. The study involves evaluations using preoperative imaging, such as radiographs and MRI, to classify spinal abnormalities and determine eligibility. Safety and outcomes are tracked over the course of a year to understand the effectiveness of the endoscopic procedures in reducing the requirement for further surgery.

Age: 18Years +All Genders
13 locations
I

Actively Recruiting

This research focuses on adolescent patients with idiopathic scoliosis who require surgical management and face a waiting period of 6 months before surgery. The main purpose is to study the factors that predict an improvement in quality of life after surgery. The study aims to better understand how surgical treatment affects adolescents with scoliosis. Participants will be asked to complete various quality of life questionnaires including the SRS-22r, SF-36 score, TAPS, and KIDSCREEN10. These assessments help evaluate different aspects of health and well-being following surgery. The study is observational, meaning it monitors patients without altering their treatment. During the study, researchers will track changes in patients' quality of life over one year using the questionnaires. The primary outcome measure is improvement in the SRS-22r score at one year. Participants will be monitored to identify factors linked to better outcomes after surgery, with the total participation lasting at least one year.

Age: 12Years - 20YearsAll Genders
1 location
M

Actively Recruiting

This research focuses on adults aged 18 to 60 who have experienced the rare and serious condition of double amputation of both forearms. It evaluates and compares two treatment strategies: bilateral allograft (transplant) of the hands and forearms versus the use of prosthetic forehands. The aim is to assess these options in terms of costs, quality of life, usefulness, satisfaction, autonomy, and social integration, building on previous findings that hand transplants can restore autonomy but require immunosuppressive treatment. Participants may receive either a bilateral allograft of the hands and forearms or prosthetic forehands. The transplant group must meet specific health criteria, such as having had their amputation at least three months prior and no severe psychiatric or uncontrolled medical conditions. The study compares the two approaches, considering both medical and economic outcomes over time. During the study, researchers will monitor costs and other important outcomes over 36 months. They will assess autonomy, quality of life, and social integration, along with medical complications related to treatments. The study builds on earlier results showing that hand transplants can help patients regain function and return to work, despite the need for ongoing immunosuppression and possible risks. This evaluation will help guide treatment choices for patients with bilateral upper limb amputations.

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

Actively Recruiting

This research investigates the factors that predict improvement in quality of life for adult patients who have undergone surgery for spinal deformity. The study focuses on adults diagnosed with spinal deformities such as scoliosis, vertical sagittal axis issues, pelvic tilt, or thoracic kyphosis. It seeks to understand which factors contribute to better recovery and quality of life one year after surgery. Participants will undergo assessments including quality of life questionnaires like the Oswestry Disability Index, Scoliosis Research Society-22R, and Short Form 36 Health Survey, along with evaluations of tobacco, alcohol, and medication use. They will also receive spinal radiography in full, face, and profile views. These procedures help researchers monitor changes and outcomes related to spinal deformity treatment. During the study, participants will be followed for up to 15 years to measure factors linked to improvement in the Oswestry disability score. Researchers will collect data through questionnaires and imaging to track participants' progress and quality of life over time. The study is observational and aims to gather valuable information to better understand recovery after spinal deformity surgery.

Age: 18Years +All Genders
1 location
S

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 international study includes both patients who have already received the Hexanium TLIF implant and those planned to receive it. The study aims to confirm the safety and effectiveness of this surgical device in skeletally mature patients by monitoring their condition over a two-year period. The treatment involves a surgical procedure called Transforaminal Lumbar Interbody Fusion (TLIF), where damaged spinal discs are removed and replaced with a cage to restore vertebral height. Screws and rods are added to stabilize the spine while the bones fuse together. Participants receive the Hexanium TLIF implant as part of their standard care, and data collection occurs at 2, 6, 12, and 24 months after surgery to assess progress and safety. During the study, participants will be asked about their back and leg pain, disability levels using the Oswestry Disability Index, and any adverse events they may experience. Researchers will collect and review this information to track the incidence of serious adverse device- or procedure-related events up to 24 months after surgery. This comprehensive follow-up ensures close monitoring of participants' recovery and the implant's performance over time.

Age: 18Years +All Genders
6 locations
S

Actively Recruiting

Researchers are evaluating the safety and performance of three SpineVision posterior fixation systems called Lumis4, Plus4, and Ulis4. These devices are used to treat patients with thoracolumbar spinal degenerative diseases, including degenerative disc disease, a condition where spinal discs break down. This observational study aims to confirm how well these fixation systems work and how safe they are for patients with these spinal conditions. The study involves patients who have already received or will receive pedicle fixation surgery using one of the SpineVision systems. This surgery supports spinal fusion or corrects spinal deformities from the thoracic spine down to the sacral spine. Data will be collected throughout the standard care process at multiple time points: before surgery, during surgery, and after surgery at 2 months, 6 months, 12 months, and 24 months. Participants will be asked about their back and leg pain using a pain scale and their disability level using the Oswestry Disability Index. Researchers will also monitor any adverse effects related to the device or procedure over a 24-month period. The study tracks both serious and non-serious events to understand the long-term safety and impact of the SpineVision posterior fixation systems.

Age: 18Years +All Genders
3 locations
S

Actively Recruiting

Adolescent Idiopathic Scoliosis (AIS) is a common spinal condition causing deformities like trunk distortion, shoulder and waist imbalance, and visible rib hump. This research aims to better understand the long-term effects, over 20 years, of treatments used for AIS, including surgical and non-surgical options. The study compares the health status of AIS patients to that of the general population of similar age, sex, and health conditions to help improve future treatment strategies. The study involves comparing groups of AIS patients who were treated more than 20 years ago, either with surgery or without surgery. Data collection is done using questionnaires to gather information on health status and healthcare usage. The goal is to analyze differences in long-term outcomes between those who had surgery and those who did not. Participants will provide information through questionnaires to assess their long-term quality of life and healthcare consumption. Researchers will evaluate self-perceived health over the span of more than 20 years after treatment. The study focuses on understanding the lasting impact of AIS treatments to guide improved care in adolescent patients.

Age: 18Years +All Genders
2 locations
S

Actively Recruiting

Healthy Volunteer

Benign total hysterectomy is a common gynecological surgery performed for benign conditions. Traditionally done through open surgery, it is now often done by laparoscopy or robot-assisted laparoscopy. A newer minimally invasive approach called V-NOTES (Vaginal-Natural Orifice Transluminal Endoscopic Surgery) avoids entry into the peritoneal cavity by using a vaginal route. This study aims to compare the success rate of outpatient treatment using the V-NOTES approach with that of conventional laparoscopic and robot-assisted laparoscopic approaches for total benign hysterectomy. Participants will undergo a total hysterectomy with or without removal of the adnexa (annexectomy) using one of three surgical methods: V-NOTES, conventional laparoscopy, or robot-assisted laparoscopy. The study is designed as a prospective, controlled, randomized trial to assess these approaches. The key intervention is the surgical removal of the uterus, and the study focuses on outpatient management following surgery. During the study, participants will be monitored for success of outpatient treatment, with the primary outcome measured 6 hours after surgery. Researchers will evaluate how well outpatient care works after each surgical approach, considering factors such as surgical trauma, pain, recovery time, and autonomy. Participants must provide informed consent and be eligible for outpatient treatment. The total duration and additional assessments beyond the primary outcome timepoint are not specified.

Age: 18Years +FEMALEPhase Not Applicable
1 location
S

Actively Recruiting

Healthy Volunteer

Researchers are investigating the combined effects of non-invasive brain and spinal cord stimulation during a cognitive-motor task to improve sensorimotor and cognitive functions in people with neurological injuries affecting the upper limb, such as cervical spinal cord injury and stroke. This Phase 2 clinical study also aims to assess how anatomical MRI, functional MRI, and neurophysiological tests can help optimize and predict the outcomes of these interventions. The study compares four types of neuromodulation interventions: transcranial direct current stimulation (tDCS), transcutaneous spinal cord stimulation (tSCS), a combination of both (tDCS-tSCS), and a sham (placebo) stimulation. Each intervention lasts 20 minutes and is performed during cognitive-motor training using the Armeo upper limb rehabilitation exoskeleton, which provides virtual reality exercises to train arm and hand movements. Participants with cervical spinal cord injury or stroke will undergo nine visits including testing and intervention sessions, while healthy control participants will have inclusion and testing visits only. Participants will be assessed immediately after each intervention at specific visits for sensory and hand function performance. The study includes clinical evaluations, neurophysiological measurements, and MRI scans to monitor effects and safety. The total participation involves multiple visits over a set timeline, with outcome measures focused on sensorimotor and cognitive improvements following the different stimulation approaches.

Age: 18Years +All GendersPhase 2
2 locations

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