Kyphosis

Researchers are evaluating a rehabilitation protocol for adults with C-shaped idiopathic scoliosis, focusing on improving spinal curvature, range of motion, and function. The study addresses challenges in current treatments by comparing mechanical traction combined with 3D apical vertebral mobilization to active exercise therapy. This approach aims to provide new insights for managing scoliosis, a condition characterized by skeletal asymmetry and muscle imbalances that can impact physical appearance and psychological well-being. The trial includes two groups: one receiving traction with mobilization three times a week for three months, totaling 36 sessions, followed by a two-month home exercise and postural instruction period; the other group performs active exercises with the same schedule and follow-up. The traction sessions involve infrared therapy, stretching, spinal manipulation, and breathing exercises, while the active exercise group follows programs designed to realign the spine and related structures. Participants undergo assessments before and after the three-month treatment and after the follow-up period. Measurements include spinal curvature using Cobb's angle, trunk and cervical range of motion, body weight, height, body mass index, and fingertip-to-floor distance. The study employs a randomized design with single masking to evaluate changes in these outcomes, tracking the effectiveness of each rehabilitation method over time.

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.

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.

Spinal deformities are common conditions affecting both children and adults, needing precise spine alignment assessment for treatment planning. Researchers are evaluating an AI-powered system called AlignProCARE to assist doctors in diagnosing and analyzing these deformities more quickly and consistently. This study involves multiple centers across Malaysia, China, and Japan to improve the AI system's performance and accuracy. Participants will have whole spine X-rays and nude back photos taken at the start and during follow-up visits. The study aims to collect 500 labeled images per center and follow 150 patients over time to measure spinal parameters and update the AI system (AlignProCARE+) using new data. This process includes detailed analysis of spinal curvature and alignment. During the study, participants' spine measurements will be evaluated using X-rays and photos, focusing on outcomes like Cobb angle, thoracic kyphosis, lumbar lordosis, pelvic tilt, and curve severity over one year. The study uses routine care for spinal deformities and monitors participants' spinal changes through imaging and AI assessment, helping to validate and refine the AI tool for clinical use.

Researchers are studying adults with spinal deformity to develop reliable methods for assessing trunk strength and overall functionality. The study aims to compare the functional ability of adults with spinal deformity to healthy controls and link these functions to the nature of their spinal deformity and muscle condition. This research also seeks to move from 2D to 3D dynamic models to better understand and improve clinical decisions in spinal deformity care, focusing on surgical outcomes like post-surgery shoulder balance. Participants include two groups: healthy volunteers and adults with spinal deformity. Both groups undergo a balance assessment scale and trunk strength measurements using electromyography (EMG). They also receive MRI scans of the spine and pelvis, along with EOS stereoradiographic full body exams. These diagnostic tests help capture detailed images and mechanical behavior of the spine. The study collects data at baseline and continues assessments up to two weeks to observe trunk muscle strength. During the study, participants will perform trunk strength tests in a sitting position using a handheld device, and their balance and posture will be evaluated through imaging and force plate measurements. Researchers will monitor trunk muscle strength from screening through week two and perform static 2D radiographic evaluations on the first day. The study involves no randomization or masking and includes adults aged 18 to 79 years. Safety, consent, and functional ability to walk certain distances independently are also assessed throughout the participation period.

Researchers are conducting an international, prospective, single-arm, multicenter observational study called the Clariance ErYs Registry. This study focuses on evaluating the safety and performance of various spine implant devices in real-world settings. It aims to collect data on complications and functional outcomes related to spine degeneration, spondylosis, deformity, tumors, and fractures. The primary goal is to assess the safety of these devices, while a secondary goal is to evaluate their impact on pain, quality of life, and daily activities. Participants will receive implantation of spine Interbody Fusion Devices and/or Posterior Fixation Systems using different types of ERISMA® and Idys® implants. The study tracks clinical outcomes over multiple time points: preoperative, 9 weeks, 6 months, 1 year, and 2 years after surgery. The implants include various models such as ERISMA® LP/LP EVO, Deformity, MIS, and Idys® devices like TLIF and ALIF with different materials and designs. During the study, participants will undergo evaluations including pain assessment using Visual Analog Score, disability measurement with Oswestry Disability Index, quality of life surveys (SF-12v2®), satisfaction ratings, radiological checks for bone fusion, and monitoring for adverse events or device deficiencies. The research team will review revision rates at two years as the primary outcome. Participant involvement spans about two years with multiple follow-up visits to collect comprehensive safety and performance data.

Researchers are evaluating the use of 3D digital surgery compared to conventional 2D surgery in traumatology and orthopedic surgery. This study aims to assess the clinical benefits and cost-effectiveness of digital surgery, which uses patient-specific instruments and personalized implants to potentially improve surgical outcomes and reduce complications. The trial focuses on three surgical procedures: distal radius osteotomy, acetabular arthroplasty, and spinal arthrodesis. Participants are randomly assigned to either the 3D digital surgery group, which involves 3D surgical planning, personalized surgical guides, and implants made through 3D printing, or the conventional surgery group, which uses 2D imaging, free-hand surgery, and generic implants. The surgery types studied are radius osteotomy, acetabular arthroplasty, and spinal arthrodesis. This is a prospective, multi-center, randomized clinical trial with double masking. Participants will undergo CT scans before surgery and 21 days after surgery to measure implant accuracy and positioning. Pain, quality of life, and functionality are assessed before surgery, 21 days after, and 12 months after surgery using specific questionnaires. Surgical time, materials used, fluoroscopy time, complications, and follow-up visits are also monitored. The study aims to provide evidence on both clinical outcomes and economic impact, with a planned end date in 2027.

This research aims to compare the effects of Pilates exercises with and without whole body vibration on posture, pain, and disability in young adults with upper cross syndrome. The study focuses on addressing posture issues like rounded shoulder posture, which is common due to prolonged sitting and technology use. Researchers will evaluate different exercise programs to determine if adding whole body vibration to Pilates exercises influences pain, posture, and disability outcomes in this population. Participants will be randomly assigned to one of two groups: one group will receive a Pilates exercise program combined with whole body vibration, and the other group will receive a traditional physical therapy program including stretching, strengthening, and postural correction exercises. Both groups will have sessions twice a week for four consecutive weeks. Before exercise sessions, hot packs will be applied for 15 to 20 minutes. The Pilates with whole body vibration group and the traditional therapy group will both complete sessions lasting about 55 minutes to one hour. During the study, participants will be assessed at baseline and after four weeks using measures such as the Numeric Pain Rating Scale, Universal Goniometer for range of motion, and the Modified Oswestry Disability Index for functional disability. Data will be analyzed to compare changes within and between groups. The trial includes detailed evaluations of posture, pain, and function to understand the benefits of the interventions. Participants will be monitored throughout the study period of six weeks.

Kyphosis, an excessive forward curvature of the upper spine causing a rounded back, is increasingly common among office workers due to prolonged sitting and poor posture. This research evaluates how physical therapy alone compares with physical therapy combined with bracing in improving posture, reducing pain, and enhancing function in people with postural kyphosis. The study also aims to find effective, non-surgical ways to manage this condition in the workplace. Participants will be randomly assigned to one of two groups: physical therapy with bracing or physical therapy without bracing. Both approaches focus on strengthening upper back muscles and reducing tension through exercises like sitting or standing upright and squeezing shoulder blades together. The study will run for at least 4 weeks to assess short-term effects. Participants will undergo assessments including the Oswestry Disability Index and Visual Analogue Scale to measure disability and pain levels after 4 weeks. The study involves office workers aged 30 to 45 who experience upper back or neck pain and spend a minimum of 6 hours daily seated for work. Researchers will monitor posture, pain, and functional outcomes to understand the benefits of each treatment approach.

Researchers are evaluating surgical outcomes and best practice guidelines for adults with complex spinal deformities. This study focuses on patients with adult spinal deformity (ASD), examining radiographic and clinical results, surgical and postoperative complications, risk factors for revision surgeries, and the impact of standard care processes on improving patient outcomes and reducing complications. The research aims to develop a universal system for classifying spine surgery complications and to understand factors affecting costs and mental health in ASD patients. The study involves multicenter, prospective observation of adults undergoing surgery for complex ASD, including those with congenital, degenerative, idiopathic, or iatrogenic spinal deformities. Complex cases are defined by specific radiographic measurements, extensive spinal fusion procedures, or geriatric criteria. Surgical interventions are determined by each patient's treating surgeon and may include procedures like three-column osteotomies or anterior column reconstruction. Researchers also assess blood management, opioid use, frailty, and mental health as parts of the treatment process. Participants will undergo full-body EOS radiographic assessments before surgery, with follow-up evaluations at 3 months, 1, 2, 5, and 10 years. Outcomes are measured using various tools including the Scoliosis Research Society 22r questionnaire, Oswestry Disability Index, Veterans RAND 12, and PROMIS scales for anxiety, depression, pain, physical function, and social satisfaction. The study also tracks adverse events, frailty scores, and hospital stay lengths to understand long-term clinical and social health outcomes. The study will continue monitoring participants through 2032 to gather comprehensive data on surgical effectiveness and patient well-being.