Scoliosis

Researchers are investigating a new method to assess Adolescent Idiopathic Scoliosis (AIS), a common spinal deformity in teenagers. They aim to improve early diagnosis and accurate evaluation of scoliosis progression by using a 3D depth camera, which offers a precise and radiation-free way to measure back surface shape. Traditional methods like trunk rotation angle (ATR) and Cobb angle rely on X-rays and clinical exams but have limitations such as radiation exposure and lower sensitivity. This study uses the Kinect v2 depth camera to capture detailed 3D images of the back, focusing on measuring the Back Height Difference (BHD) as a quantitative indicator of spinal deformity. Participants will also have their ATR measured with a Scoliometer and Cobb angle assessed by spinal specialists. Measurements are repeated by different assessors to ensure accuracy, with procedures spaced by five minutes and averages taken. If Cobb angle measurements vary significantly, a senior physician will review them. Participants aged 10 to 18 with diagnosed AIS will undergo these assessments during a short-term inpatient stay of five days. Researchers will collect data on back height difference and trunk rotation angle on the first day of admission. The study monitors participants' ability to complete standardized tests without any treatment intervention. This observational study provides a safer, radiation-free alternative to traditional scoliosis assessment methods.

Researchers are evaluating adolescents with idiopathic scoliosis using 3D imaging technology with depth cameras to measure back height difference (BHD) and angle of trunk rotation (ATR). The study aims to compare these measurements before and after conventional treatments such as massage, exercise therapy, and bracing. Statistical analysis will be used to explore the relationship between BHD and ATR and to assess how well BHD detects short-term treatment changes. The study involves a short-term inpatient period of 5 days during which participants receive tailored exercises guided by X-ray mapping, including 3D therapy, breathing techniques, and spinal manipulation known as Tuina. Measurements of BHD and ATR are taken on the first and fifth days of admission to evaluate changes with treatment. Participants will undergo assessments of back height difference and trunk rotation angle at admission and after 5 days of treatment. Researchers will monitor these physical changes to understand treatment effects. The trial is observational and involves adolescents aged 10 to 18 years diagnosed with idiopathic scoliosis. The total participation lasts for the 5-day inpatient treatment period.

Adolescent Idiopathic Scoliosis (AIS) is a spinal growth defect mostly affecting prepubertal children aged 10 to 14 years, causing lateral curves and rotations of the spine. AIS can lead to posture problems, back pain, and visible asymmetry, such as uneven shoulders. Early diagnosis and proper treatment are important to stop curve progression and reduce related health issues. Current surgical decisions rely on two-dimensional X-rays, which may not capture the full three-dimensional and dynamic nature of the spine's deformity, leading to suboptimal outcomes and revision surgeries. Treatment options include wearing a brace for immature patients with curves between 25 and 40 degrees. If the curve does not respond and growth potential remains, vertebral body tethering (VBT), a minimally invasive FDA-approved device that gradually corrects scoliosis by slowing growth on one side, may be considered. For curves of 50 degrees or more with little growth left, spinal fusion surgery is recommended to permanently correct the spine by attaching vertebrae with surgical hardware. The study aims to improve surgical planning by using 3D dynamic and mechanical information from musculoskeletal models, moving beyond current 2D static assessments. Participants will undergo questionnaires, radiological EOS scans, and 3D dynamic motion analyses to gather detailed data on spinal deformity and mechanics. Researchers will measure 3D dynamic parameters up to two years after surgery and develop biomechanically-informed 3D models specific to AIS. This approach hopes to help surgeons make evidence-based decisions, improve patient outcomes, reduce complications, and lower the costs associated with AIS treatment. The study is sponsored by Universitaire Ziekenhuizen KU Leuven and involves patients aged 10 to 35 undergoing VBT or selective fusion surgery.

Researchers are comparing the effectiveness of two serotonin receptor blockers, palonosetron and granisetron, given with dexamethasone to prevent early and delayed postoperative nausea and vomiting (PONV) in adolescents and adults with idiopathic scoliosis undergoing posterior spinal fusion surgery using total intravenous anesthesia (TIVA). The study aims to find out which drug better prevents nausea and vomiting, the need for rescue medications, side effects, and patient satisfaction. Participants will be randomly assigned to one of two groups: one group receives palonosetron before anesthesia begins and saline placebo at wound closure, while the other group receives saline placebo before anesthesia and granisetron at wound closure. Both groups will also receive dexamethasone as part of their antiemetic treatment. Standard anesthesia with remifentanil and propofol will be used, and morphine will be given before surgery ends for pain. During the study, nausea, vomiting, and retching will be monitored at 1, 4, 12, 24, and 48 hours after surgery. Researchers will evaluate the need for additional antiemetic drugs, any side effects from the study drugs, and patient satisfaction at 48 hours. The trial is double-blinded and randomized, with a total planned enrollment of 92 participants aged 10 years and older with idiopathic scoliosis.

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.

Researchers are evaluating the RESILIENT Scoliosis Brace System in children with idiopathic scoliosis to see if it can prevent the spinal curve from worsening beyond 35 degrees during growth. This study also aims to learn about the safety, comfort, and usability of this semi-rigid, adjustable brace while monitoring how well participants follow the prescribed wear time and force levels. The study focuses on children aged 9 to 16 years with specific types of scoliosis and skeletal maturity scores. Participants will be fitted with the RESILIENT brace, which includes sensors to track force and wear time. They will wear the brace daily as recommended by their physician throughout their growth period. Clinic visits will occur about 4 to 6 weeks after starting treatment and then approximately every 6 months. Standard spine X-rays will be taken to monitor curve progression, and participants will complete questionnaires about quality of life and their experience with the brace. During the study, participants will be followed from the beginning of brace treatment until they finish growing and complete treatment, which may take up to 36 months. Researchers will evaluate treatment success based on spine curve progression at skeletal maturity and examine in-brace curve correction, brace use compliance, and changes in curve magnitude after treatment ends. Quality of life will be assessed using patient-reported measures throughout the study, and an exit survey will be completed at study completion.

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.

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.

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.