Clinical Research Directory

Effect of Bifidobacterium Breve Supplementation on the Onset and Progression of Idiopathic Scoliosis

Researchers hypothesized that Bifidobacterium breve Supplement could reduce the progression rate of idiopathic scoliosis in children and potentially prevent the occurrence of new cases of scoliosis.

Advanced SPinal Innovations With Robotics and Enabling Technology Registry

Creation of a pediatric robotic spine surgery registry will allow for data collection and analysis on the coupled use of robotics and navigation, as well as patient-specific rods in pediatric spine deformity surgery across participating study institutions. Eventually, an educational and informative framework for this technology will be established.

Effect of Bright Light Therapy on Idiopathic Scoliosis

This trial aims to investigate whether morning bright light therapy can reduce the progression rate of idiopathic scoliosis in children and potentially prevent its de novo development.

Implementation of Specific Tailored Exercises Program Versus Exergaming Exercises on Cobb Angle in the Treatment of Adolescent Idiopathic Scoliosis.

this study will be conducted to investigate the difference between specific tailored exercise program and exergaming exercises on Cobb's angle, angle of trunk rotation, pulmonary function and quality of the life in adolescent idiopathic scoliosis.

REFLECT Scoliosis System Post Approval Study

The purpose of this multi-center, prospective, single-arm registry Post-Approval Study (PAS) is to evaluate the radiographic and clinical outcomes of 100 patients with idiopathic scoliosis treated with the REFLECT™ Scoliosis Correction System, as a condition of HDE approval

Evaluation of Analgesia for Spine Fusion Elective Surgery in Children

The multicenter PRECISE Analgesia (Prospective Randomized Evaluation of Analgesia for Idiopathic Scoliosis Spine Fusion Elective Surgery in Children) trials will a) implement and investigate the efficacy and safety of multidose methadone-based standardized enhanced recovery after surgery (ERAS) protocol, and b) develop personalized ERAS protocols including precision methadone and oxycodone dosing1,2 and c) personalized analgesia for the safe and effective opioid-sparing management of surgical pain after posterior spine fusion (PSF) in children.

Three-Dimensional Correction Methods for Idiopathic Scoliosis in Adolescent

This study aims to compare the effectiveness of "Schroth method" and "Scientific Exercise Approach to Scoliosis" for correcting idiopathic scoliosis in adolescents.

Characterization of Visual Perception Impairments in Patients With Idiopathic Scoliosis

Scoliosis is more than just a curve in the spine; it is a complex, 3D twisting of the backbone. While it can be caused by birth defects or tumors, the most common type-idiopathic scoliosis-appears in healthy teenagers for no clearly known reason. The Theory of Balance Researchers believe that scoliosis might actually be caused by a "glitch" in how the body stays upright. Instead of the spine curving on its own, the curve might be the body's way of compensating for a poor sense of balance. To stay balanced, the human brain relies on three main "inputs": 1. The Vestibular System: Located in the inner ear (detects movement). 2. Proprioception: The body's "inner map" (sensing where your limbs are). 3. Vision: Seeing the world around you to stay oriented. The Goal of the Study Even though humans rely heavily on their eyes to stay balanced, the role of vision in scoliosis has not been studied very much. This experiment aims to test the hypothesis that teenagers with scoliosis have trouble processing visual information to maintain their posture. By using advanced motion analysis, researchers want to see if a "misunderstanding" of visual cues is contributing to the spinal deformity.

Effect of Vitamin A Supplementation on Idiopathic Scoliosis

This study aims to investigate whether vitamin A supplementation can influence spinal curve magnitude in idiopathic scoliosis children and potentially prevent its de novo development.

Effect of Adenotonsillectomy on Spinal Curve Magnitude in Children With Sleep-Disordered Breathing

This study aims to determine the effect of adenotonsillectomy (AT) surgery on the progression of spinal curvature in children with mild sleep-disordered breathing (SDB) and concurrent scoliosis, as well as its potential role in preventing the de novo development of scoliosis in children with SDB.

Analgesic Efficacy of Multiple Mid-Transverse Process to Pleura (MTP) Block and PCA in Idiopathic Scoliosis Patients Undergoing Posterior Spinal Fusion

This study aims to compare the analgesic efficacy of multiple mid-transverse process to pleura (MTP) block and PCA in idiopathic scoliosis patients undergoing posterior spinal fusion surgery.

Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Complex

Multicenter, multinational Post-Market Clinical Follow-Up (PMCF) study on the safety and performance of Ennovate® Complex - A prospective, pure data collection of all Ennovate® scoliosis patients in selected centers (not interventional, multicentric)

Multicentric Evaluation of Enhanced Recovery After Surgery Protocol in Adolescent Idiopathic Scoliosis Surgery

Adolescent idiopathic scoliosis is a deformation of the spine affecting 2 to 4% of under 18 years old population. This can have severe physical or psychological impact during adulthood. The deformation causes mechanical constraints resulting in early osteoarthritis, which results in adulthood disability. There is also an impact on the respiratory function in most severe cases of idiopathic scoliosis. Adolescents affected by a scoliosis with an angle of 40° of more undergo a surgery called posterior fusion during adolescence to limit these impacts. In France, more than 1000 adolescent patients undergo a surgery called posterior spinal fusion for their severe scoliosis. This aims to straighten the spine by bone grafting all the vertebras included in the scoliosis. Two metal rods are implanted to favour osteosynthesis of the straight spine. This intervention suffer of a bad image and worries the patients and their parents, as it needs metal implants near the spinal cord. The worry comes from the most severe complication that may happen exceptionally following this surgery, which is a definitive paraplegia. The scar is quite large and the surgery reduces the mobility of a part of the spine. The intervention produces a quite large haemorrhage, which leads to a diminution in haemoglobin level, resulting in a fatigue during the following weeks. On the following days, the patient will need a specific protocol of pain management including morphine-based and anti-inflammatory drugs. This intervention will often require a 5 to 7 days hospitalization with a 1 to 2 month convalescence period at home or in rehabilitation centre. This intervention is performed on adolescent patients without comorbidities. Moreover, the surgical approach is not profound passing between the para-vertebral muscles with no close large blood vessels or major organs. The pain is caused by correction tensions and the access to the vertebras during the surgery. Surgical techniques have considerably evolved allowing shorter interventions and to reduce the loss of blood. The association between morphine-based treatments and grade I analgesics enables an effective pain management. This intervention appears to perfectly suit to an enhanced recovery after surgery procedure (ERAS). ERAS is a set of procedure meant to enhance its tolerance and to reduce its morbidity and the hospitalization duration after surgery and the recovery duration. ERAS is well developed in adult patients undergoing surgery, it is also well described in paediatric patient especially on adolescent scoliosis surgeries. As the pain is well controlled during the hospitalization as well when the patient get back home, there are very few obstacles to an ERAS procedure in this indication for a patient without comorbidities. Numerous articles report experiences of medical staff with ERAS protocols. Generally, the set of measures includes: * Before surgery: Providing information and therapeutic patient education, iron supplementation, physiotherapy, skin disinfection, digestive preparation against constipation * During surgery: recuperations of blood cells to limit blood loss, use of modern tools to facilitate the positioning of pedicle screws, surgery performed by 2 surgeons * After surgery: Pain management until stopping of analgesics by patient and maintenance of a link between the patient at home and the hospital staff after end of hospitalization The articles published about ERAS reports a favourable experience of such protocols with an efficient pain management, reduced hospitalization durations without increasing morbidity or re-hospitalizations. However, no studies have studied and proved by a robust scientific method the benefits of ERAS in adolescent scoliosis. No studies evaluate the patients' quality of life or follow the patient for more than 6 months after surgery (limiting the assessment of long term complications e.g. infectious complications). The link between hospital staff and the patient after his return back home is not described as well. This research project aims to confirm with a robust scientific approach that ERAS protocols in idiopathic scoliosis in adolescents allow to reduce the duration of hospitalization compared to standard of care procedures while improving quality of life after surgery.

Brace Treatment for Idiopathic Scoliosis; PReventing Idiopathic SCOliosis PROgression

Idiopathic scoliosis is the most common spinal deformity in children and adolescents with an estimated prevalence of 3%. About one tenth of the children with scoliosis develop a deformity that requires treatment with brace or surgery with the current treatment protocol. When brace treatment for scoliosis is indicated, standard treatment consists of bracing 20 hours or more per day. Outcomes of brace treatment depend to a large extent on wearing time and since many adolescents feel uncomfortable in the brace, it is of importance to combine efficacy and comfortability of the brace.

Scoliosis-specific Exercises for Mild Idiopathic Scoliosis

Idiopathic scoliosis is the most common spinal deformity in children and adolescents with an estimated prevalence of 3%. About one tenth of the children with scoliosis develop a deformity that requires treatment with brace or surgery with the current treatment protocol. In Sweden, mild scoliosis curves not requiring treatment, but at risk for progression during childhood, are only observed until skeletal maturity without active treatment. If progression occurs and treatment is required, standard treatment consists of bracing 20 hours or more per day. Scoliosis-specific exercises have been reported to be a possible treatment modality in terms of halting progression in mild scoliosis, but the findings are not generally accepted.

Trial on Three Treatments for Scoliosis

Idiopathic scoliosis is a three-dimensional structural deformity of the spine that occurs in children. Recent reviews on bracing and exercise treatment have provided some evidence for effect of these interventions. The purpose of this study is to compare the effectiveness of night time bracing, scoliosis specific exercises and physical activity prescription in adolescents with idiopathic scoliosis.

Implementation of Momentum SpineTM: a New 3D Imaging Software for Idiopathic Scoliosis

Brief Summary The goal of this clinical trial is to evaluate the implementation of Momentum Spine™, a new 3D imaging software designed to improve the monitoring and management of idiopathic scoliosis in children aged 8-14 years. Idiopathic scoliosis affects 1-3% of the pediatric population and is currently monitored through hospital visits with radiographic imaging every 4-6 months, which exposes patients to cumulative radiation over time. This study explores whether Momentum Spine™ can provide a safer, more accessible alternative by enabling at-home monitoring using clinical photographs taken on smartphones. The primary questions this study seeks to answer are: Can Momentum Spine™ accurately predict scoliosis progression, including Cobb angle changes, compared to standard radiographic assessments? Can the use of Momentum Spine™ reduce the number of X-rays required and improve the timing of clinical follow-ups? Does the use of Momentum Spine™ affect patient satisfaction, healthcare utilization, and overall quality of life? This study is a prospective, two-arm randomized controlled trial conducted at CHU Sainte-Justine. Participants will be divided into two groups: the control group will receive standard care, which involves regular clinical visits and radiographic evaluations; the intervention group will use Momentum Spine™ at home, alongside standard care. Intervention Details Participants in the intervention group will: Use the Momentum Spine™ application to capture 3D images of their torso at home every two months. These images will be processed by Momentum Spine™ algorithms to assess curve progression. Participants will receive notifications and guidance on performing scans at home, supported by the study team to ensure accuracy. The primary outcomes include clinical measures such as changes in Cobb angle at 1 and 2 years, curve progression of more than 5 degrees, whether the main curve reaches 45 degrees, and the need for surgical referral. Secondary outcomes focus on the accuracy, sensitivity, and specificity of Momentum Spine™, as well as patient-reported measures such as health-related quality of life and satisfaction with care, users' acceptability of the software, healthcare services utilization and pathway costs. This study also aims to address key challenges in scoliosis care, including reducing radiation exposure, improving follow-up timing to align with growth spurts, and providing equitable access to care for families who may live far from specialty clinics. By validating the performance of Momentum Spine™, this trial has the potential to transform scoliosis management, ensuring safer and more effective care pathways.

Distinguishing Non-Specific Low Back Pain from Scoliosis-Related Pain Via Quality of Life Questionnaires

Vertebral deformities, such as scoliosis, can have a significant impact on the physical and psychological health of patients. Over time, specific tools have been developed to investigate the extent of this impact; the SRS-22 (Scoliosis Research Society) questionnaire is the most commonly used instrument for assessing quality of life (QoL) in patients with idiopathic scoliosis. The Oswestry Disability Index (ODI), on the other hand, was developed to evaluate the quality of life in adult patients with chronic non-specific low back pain. The clinical protocols at our institute involve the regular and continuous evaluation of the quality of life in patients undergoing treatment and monitoring for scoliosis and other vertebral deformities. To this end, the SRS-22 questionnaire and the ODI questionnaire are employed, along with other measures such as the COMI (Core Outcome Measure Index) and ISYQoL (Italian Spine Youth Quality of Life). The aim of this study is to compare the properties of the ODI with those of the SRS-22 questionnaire in adults, by analyzing differences between individuals with non-specific low back pain and those with scoliosis. The secondary objective involves a sub-analysis based on the severity of scoliosis, dividing curves into major (30° Cobb or higher) and minor (below 30° Cobb). Finally, if sufficient data are available, the study will also evaluate other commonly used questionnaires (COMI and ISYQoL).

Erector Spinae Plane Block v.s Patient Controlled Analgesia in Correction Surgery for Idiopathic Scoliosis

Scoliosis correction surgery involves extensive surgical wounds, intense intraoperative stimulation, and severe postoperative pain, often necessitating the use of potent opioids. However, there is a critical clinical need for effective pain management strategies that both ensure sufficient analgesia and minimize opioid-related adverse effects. The Erector Spinae Plane Block (ESPB) has shown promise as an effective analgesic technique, but its application in scoliosis correction surgery has not been reported.We hypothesize that ESPB provides superior postoperative analgesia compared to patient-controlled intravenous analgesia (PCA) pumps. Specifically, ESPB is expected to significantly reduce postoperative pain scores, decrease perioperative opioid consumption, and mitigate opioid-related side effects. This study is a randomized controlled trial involving 40 participants undergoing scoliosis correction surgery, randomized into two groups: the ESPB group and the PCA group. The primary outcome measure is the resting pain score at 2 hours postoperatively, which will be used to evaluate the efficacy of ESPB. Secondary outcomes include perioperative opioid consumption and the incidence of opioid-related adverse effects. The study aims to provide evidence for ESPB as an innovative and effective method for postoperative analgesia in scoliosis correction surgery.

Assessment of Skeletal Maturity Using Proximal Femoral Epiphysis in Patients With Scoliosis

This study aims to explore the use of proximal femoral head for the assessment of skeletal maturity in patients with idiopathic scoliosis. The aim is to validate the use of the stages of proximal femoral epiphyseal closure in assessing pubertal growth landmarks in this patient cohort. The grading system of this skeletal maturity index will be established and its reliability and reproducibility in clinical use will be examined.

Precision Medicine for Nociception, Sngception and Proprioception.

Precision medicine is defined as "an emerging approach for disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle for each person" by the Precision Medicine Initiative. Patients have different response to different treatment modalities, and sore/pain medicine is no exception. In our experience, low-level laser (LLL), ultrasound, and prolotherapy can reduce sore /pain through different genetic pathway. Whether the therapeutic effect is controlled by the genetic variants of those sore /pain related genes or not, is still in debate. The aims of this study are (1) To set up next generation sequencing (NGS)-based approach to find genetic variants which can determine the response of sng/pain treatment modalities and the phenotype of idiopathic scoliosis. (2) To find possible metabolomics and proteomic markers of sng/pain. (3) To determine the algorithm of precision medicine for sng/pain control via the genetic markers. Investigators will recruit 80 myofascial pain participant and 80 idiopathic scoliosis participant from Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital Bei-Hu Branch in 2023 and 2025. The myofascial pain participant participants will receive LLL, ultrasound, and prolotherapy, and the therapeutic effect will be recorded. The clinical trial will evaluate the Sng / pain (VAS) and muscle tone of the idiopathic scoliosis participant. The blood and urine samples from the first, the second, and the third visits will be analyzed by next generation sequencing, and mass spectrometry to find the possible biomarker in 2024 and 2025. Investigators expect to develop the individualized treatment plan by means of these biomarkers. Hopefully, the results will be widely applied in the field of sore /pain medicine.

A Suggested Rehabilitation Protocol for the Treatment of C-shape Scoliosis

This study aims to compare the effectiveness of mechanical traction and 3D apical vertebral mobilization and active exercises on Cobb's angle, spinal ROM, and function in patients with C-shaped scoliosis.

Investigation of Gait Pattern in Idiopathic Scoliosis

Scoliosis is a condition characterized by an abnormal curvature of the spine, which can affect an individual's gait. Scoliosis can alter body balance and weight distribution. Pedobarographic analysis identifies imbalances and abnormal pressure points by measuring the distribution of pressure applied to the sole of the foot. This examination helps detect abnormalities in the gait mechanics of individuals with scoliosis. Gait analysis can identify long-term foot and leg problems caused by scoliosis at an early stage, allowing for early interventions to prevent more serious issues. The aim of this study is to analyze gait in individuals with idiopathic scoliosis and compare it with that of healthy individuals. The study will include 30 scoliosis patients who visited the Department of Orthopedics and Traumatology at Gazi University Hospital and were diagnosed with idiopathic scoliosis by a specialist physician. The gait patterns of the patients will be evaluated using pedobarography. Information about the type and degree of scoliosis will be obtained from hospital records. The results of this study may provide an objective and detailed evaluation of gait and pressure distribution disorders in individuals with scoliosis and may contribute to more effective treatment plans.

Ultrasound Guided Bilateral Retrolaminar Block as Analgesia for Adolescent Idiopathic Scoliosis Correction

Scoliosis is a structural, tridimensional deformity of the spine. Characterized by lateral curvature and rotation of the vertebrae with functional limitations and cosmetic problems, idiopathic scoliosis, which accounts for 75% to 80% of all scoliosis, is the most common of all types. (1, 2) Surgical treatment is an effective way to correct severe spine deformity when the deformity progressively worsens and cannot be positively corrected by brace treatment. Spinal correction surgery is one of the most invasive surgical procedures and usually results in moderate to severe levels of postoperative pain. (3) Severe pain may induce implant complications such as construct dislodgement, broken instrumentation, and implant loosening which requires additional revision procedures These conditions adversely affect postoperative outcomes.(4) In the past several years, pain has become an important indicator for evaluating indicators of outcome and quality of life after surgery. Effective analgesia after surgery could improve patients' prognosis.(5) The retrolaminar block is a recently described ultrasound-guided technique in which local anesthetics is injected into the fascial plane between the posterior surface of the thoracic lamina and the overlying transverso-spinalis muscles. (2) The available evidence indicates that retrolaminar block is effective in reducing opioid requirements and improving the pain experience in a wide range of clinical settings. They are best employed as part of multimodal analgesia with other systemic analgesics