Adolescent Idiopathic Scoliosis

30

Review clinical trials related to Adolescent Idiopathic Scoliosis. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

Kids With Iron Deficiency and Scoliosis

This study is a randomized controlled trial of preoperative oral iron supplementation, to identify whether iron deficiency is a modifiable risk factor for adverse surgical outcomes such as red blood cell transfusion and diminished postoperative cognitive and physical capacity in adolescents undergoing scoliosis surgery. Research Question(s)/Hypothesis(es): Primary * Iron supplementation will reduce the incidence of perioperative RBC transfusion in iron deficient scoliosis patients undergoing spinal fusion. Secondary * Iron supplementation will reduce postoperative neurocognitive functional declines in iron deficient scoliosis patients undergoing spinal fusion. * Iron supplementation will improve patient-reported physical functioning in iron deficient scoliosis patients undergoing spinal fusion.

Participants needed: 275
Trial details
Age: 10-26Biological sex: AllType: InterventionalSponsor: Columbia UniversityUpdated: Jun 26, 2026Locations: 1
Eligibility criteria

10-26 years old; [+4]

taking or planning to take iron-containing supplement on patient's own volition,... [+11]

Status: Recruiting

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.

Participants needed: 700
Trial details
Age: 0-21Biological sex: AllType: ObservationalSponsor: Boston Children's HospitalUpdated: Jun 22, 2026Locations: 10Duration: 5 Years
Eligibility criteria

Diagnosis of a spine deformity [+3]

Status: Not yet recruiting

The Use of a Comfort Tote to Improve Recovery in Pediatric and Adolescent Patients After Surgery

The goal of this clinical trial is to learn if the use of Comfort Tote can treat pain and anxiety in adolescents with idiopathic scoliosis undergoing posterior spinal fusion. The study aims to answer two questions: 1. To characterize the effectiveness and determine the impact of integrative therapy interventions of the Comfort Tote use in reducing self-reported pain, anxiety, and stress among pediatric patients with AIS undergoing PSF. By comparing self-reported pain, anxiety, and stress scores, as well as documented Morphine Milligram Equivalents (MMEs) and Numeric Rating Scale (NRS) pain scores, between patients using non-therapeutic and therapeutic Comfort Totes. 2. To evaluate the impact of an educational video on the use of the Comfort Tote. This will assess whether the inclusion of instructional content enhances understanding and application of the Comfort Tote, thereby improving patient outcomes in pain management, anxiety reduction, and overall satisfaction with care. It is hypothesized that the therapeutic Comfort Tote intervention with the educational video will provide the highest patient satisfaction and greater tote usage, with decreased patient pain, stress, and anxiety levels. The findings from this pilot study will provide crucial insights into establishing a new standard of care for pediatric patients undergoing PSF and potentially provide baseline data for use in larger, multicenter randomized controlled trials.

Participants needed: 50
Trial details
Age: 12-21Biological sex: AllType: InterventionalSponsor: Columbia UniversityUpdated: Jun 8, 2026
Eligibility criteria

Patients of all genders, racial, and ethnic groups aged between 10 and 21 that h... [+3]

Patients who have had growing rods and revisions, those who have local or system... [+1]

Status: Recruiting

The Effect of Erector Spinae Plane Block (ESPB) on Pediatric Pain Management Following Posterior Spinal Fusion (PSF) Surgery

This study is being done to better understand the efficacy of an erector spinae plane block (ESPB) in pain management for children with Adolescent Idiopathic Scoliosis or Neuromuscular Scoliosis undergoing Posterior Spinal Fusion surgery. The study team is trying to find out if receiving the ESPB leads to less pain and less need for pain medication after surgery. The ESPB involves an injection of a local anesthetic, ropivacaine, into your child's back muscles to help block pain signals.

Participants needed: 42
Trial details
Phase: Phase 3Age: 10-18Biological sex: AllType: InterventionalSponsor: University of California, San FranciscoUpdated: May 1, 2026Locations: 1
Eligibility criteria

Diagnosis of Adolescent Idiopathic Scoliosis (AIS) or neuromuscular scoliosis [+1]

Patients with forms of scoliosis other than AIS or NM Scoliosis. [+2]

Status: Recruiting

Brace Monitoring for Adolescent Idiopathic Scoliosis (AIS)

The overall aim of the study is to utilize a novel device and smartphone application in order to improve measurement of patient compliance with at-home bracing for scoliosis as well as create a more accurate assessment of brace fit via continuous and objective measures of tension. These ground-breaking metrics will provide analyzable data to more accurately reflect and predict actual patient compliance as well as allow for further exploration of how to increase compliance, and thus, efficacy of bracing; it will additionally allow both physicians and patients to have a more reliable measure for brace fit by providing them with continuous data of fit via tension, and provide built-in feedback mechanisms to the patient to ensure proper tightness of the brace. Additionally, the study will investigate whether providing the wearer's own brace-wear compliance information directly to the patient and their caregiver(s) via the mobile app will further improve rates of compliance as compared to those who do not receive the same feedback mechanism.

Participants needed: 87
Trial details
Age: 8-17Biological sex: FemaleType: InterventionalSponsor: Columbia UniversityUpdated: Apr 3, 2026Locations: 1
Eligibility criteria

Diagnosis of Adolescent Idiopathic Scoliosis (AIS) [+3]

Status: Not yet recruiting

Diaphragm Mobilization in Adolescent Idiopathic Scoliosis

Adolescent idiopathic scoliosis (AIS) is a three-dimensional spinal deformity that can affect posture, trunk movement, and respiratory function. Changes in the shape of the rib cage may influence diaphragm function and breathing mechanics in individuals with scoliosis. The Schroth Best Practice (SBP) exercise program is commonly used in the conservative treatment of scoliosis and focuses on posture correction and scoliosis-specific exercises. However, the additional benefits of manual diaphragm mobilization combined with this exercise program are not well known. The aim of this randomized controlled trial is to investigate the effect of diaphragm mobilization added to the Schroth Best Practice program in adolescents with idiopathic scoliosis. Participants will be randomly assigned to two groups: one group will perform the SBP exercise program alone, and the other group will receive SBP exercises combined with diaphragm mobilization. The intervention will be performed three times per week for six weeks. Assessments will be conducted at baseline, at the end of the 6-week intervention, and at a 12-week follow-up. Outcomes will include respiratory function measured by spirometry, trunk rotation, thoracic mobility, trunk flexibility, quality of life, and body image. The results of this study may help determine whether adding diaphragm mobilization to scoliosis-specific exercise programs improves clinical outcomes in adolescents with idiopathic scoliosis.

Participants needed: 42
Trial details
Age: 10-18Biological sex: AllType: InterventionalSponsor: Marmara UniversityUpdated: Mar 19, 2026
Eligibility criteria

Adolescents aged between 10 and 18 years [+4]

Non-idiopathic scoliosis (e.g., neuromuscular, congenital, or syndromic scoliosi... [+7]

Status: Recruiting

3D, Dynamic and Mechanically-informed Decision Making in AIS

Adolescent Idiopathic Scoliosis (AIS) is a growth defect of the spine that primarily occurs in prepubertal children between the age of 10 to 14 years, affecting approximately 3% of these otherwise normal children. AIS has been associated with problems related to posture, load-related back pain, as well as aesthetic problems, e.g. the induced asymmetry of the shoulder. Therefore, early diagnosis followed by the appropriate treatment is vital to prevent further curve progression of AIS and minimize the health-related complications of these patients. The current treatment recommendation to stop curve progression for an immature patient with a scoliosis curve between 25 and 40 degrees is to wear a brace. If the curve in the skeletally immature patient is not responding to the brace treatment, dynamic scoliosis correction by vertebral body tethering can be considered when there is still some growth potential left. State-of-the-art guidelines for the selection of fusion levels are currently mainly based on two-dimensional (2D) static radiographic parameters (such as, the Cobb angle and Shoulder balance) and a qualitative assessment of 2D bending or traction radiographs. Several classification systems and algorithms that are based on the 2D static radiographic (X-ray) parameters exist to assist surgeons in determining the appropriate levels to be instrumented. Despite this wide range of classification systems and detailed guidelines available in the literature, spinal fusion does not always yield satisfying 2D radiographic clinical outcome, with revision rates ranging from 3.9% to 22%. Overall, the surgeon is presently not provided with 3D dynamic and mechanical information regarding the deformity of the AIS to guide the decision-making. Obtaining this vital 3D dynamic information regarding the curvature and mechanical behavior of the spine will allow the surgeon to make an evidence-based and well-informed decisions in the treatment of the AIS patient. Consequently, realizing these objectives has the potential to improve patient satisfaction, reduce the postoperative complications and accordingly reduce socio-economic costs associated with AIS treatment. Recent advances in the use of subject specific musculoskeletal models will form the basis to realize this shift from 2D to 3D dynamic in AIS care.

Participants needed: 100
Trial details
Age: 10+Biological sex: AllType: InterventionalSponsor: Universitaire Ziekenhuizen KU LeuvenUpdated: Mar 9, 2026Locations: 1
Eligibility criteria

Patient diagnosed with Adolescent Idiopathic Scoliosis [+3]

Patient has undergone a fusion or VBT procedure before [+2]

Status: Recruiting

Dysport ® as an Adjunctive Treatment to Bracing in the Management of Adolescent Idiopathic Scoliosis

This study evaluates the combined effect of botulinum toxin A (administered as Dysport® (Ipsen Pharmaceuticals)) and bracing in children with adolescent idiopathic scoliosis. Two thirds of patients will be treated with Dysport® and bracing, while the remaining patients will be treated with placebo and bracing.

Participants needed: 90
Trial details
Phase: Phase 4Age: 10-16Biological sex: AllType: InterventionalSponsor: Johns Hopkins UniversityUpdated: Dec 9, 2025Locations: 1
Eligibility criteria

Clinically determined idiopathic nature of scoliosis [+6]

Diagnosis of congenital scoliosis, neuromuscular scoliosis, or other "reason" fo... [+6]

Status: Recruiting

MRI-Guided Dynamic Support System for Scoliosis Correction

This prospective pilot study evaluates the feasibility and effectiveness of an MRI-guided dynamic support system (MRI-DSS) for rapid, quantitative correction of adolescent idiopathic scoliosis (AIS). The system uses MRI-compatible air padding supports and programmable pneumatic control to apply and adjust corrective forces in real time. AIS patients underwent MRI-guided bracing, with Cobb angles and biomechanical parameters measured at each pressure level.

Participants needed: 10
Trial details
Age: 10-16Biological sex: AllType: InterventionalSponsor: Chinese University of Hong KongUpdated: Nov 24, 2025Locations: 1
Eligibility criteria

Age: 10-16 years [+4]

Age <10 or >16 years [+3]

Status: Recruiting

Interest of Adapted Physical Activity by Tele-rehabilitation in Chronic Pathology - Idiopathic Scoliosis in Adolescents

This study is a randomised controlled trial designed to compare two adapted physical activity treatments for adolescent idiopathic scoliosis (AIS). The main hypotheses it aims to address are as follows: * Treatment with a HIIT (High-Intensity Interval Training) type training program via tele-rehabilitation, supervised by an adapted physical activity teacher, is effective in AIS. * A 12-week physical activity program maintains this efficacy over the long term. To test this hypothesis, Two groups of adolescents will be evaluated: a first group made up of non-athletic adolescents suffering from Idiopathic Scoliosis who will benefit from a tele-rehabilitation (physical activity sessions at home supervised by a teacher in adapted physical activities by video). A second group, control, also made up of non-athletic adolescents suffering from Idiopathic Scoliosis who will benefit from a self-program at home consisting of exercises specific to their scoliosis.

Participants needed: 70
Trial details
Age: 13-17Biological sex: FemaleType: InterventionalSponsor: Association des Paralysees de France (APF)Updated: Oct 3, 2025Locations: 1
Eligibility criteria

Affiliated to a social security system [+8]

Subject with secondary scoliosis: neurological, orthopedic, malformative... [+4]

Status: Not yet recruiting

Assessment of Respiratory Parameters, Aerobic Capacity and Sleep Quality in Thoracic AIS

This study aims to compare respiratory parameters -including pulmonary function and respiratory muscle strength-as well as aerobic capacity and sleep quality in individuals with thoracic adolescent idiopathic scoliosis. Participants will be categorized according to the ISST classification into T-type and TL-type curvature patterns. The study will evaluate differences between these groups using standardized clinical assessments.

Participants needed: 30
Trial details
Age: 12-20Biological sex: AllType: ObservationalSponsor: Uskudar UniversityUpdated: Sep 22, 2025Locations: 1
Eligibility criteria

Not listed

Status: Recruiting

Schroth and Pilates Exercises in Idiopathic Adolescent Scoliosis

Adolescent idiopathic scoliosis (AIS) is a common anomaly that is frequently seen in prepubertal growth and is characterized by deviation and rotation of the spine, causing high level of disability. Pubertal development and asymmetrical load distribution increase the progression of the deformity. Affecting the spinal structure and its movement can affect the structures and cause problems in many areas such as pain, balance, respiration, mental health and quality of life. AIS can cause functional disability by causing deterioration in chest wall mechanics, weakness in respiratory muscles and limitation of functional capacity. As the disease progresses, prolonged hypoinflation and atelectasis lead to irreversible atrophy of the lungs and further reduction in lung volume. Displacement and/or compression of the heart due to thoracic deformity may not allow for the required increase in stroke volume during exercise. In severe cases, patients are at risk of developing pulmonary hypertension due to chronic respiratory failure and chronic atelectasis, chronic hypoxemia, chronic hypercapnia. In addition, muscle atrophy and muscle weakness in AIS are thought to cause muscle imbalances and loss of balance. Exercise is the most appropriate treatment for low and moderate AIS cases due to its low cost and low risk of complications. Exercises prevent the development of many problems by controlling the severity of curvature and preventing the progression of curvature. It is thought that scoliosis exercises can delay or even prevent surgery and reduce the duration or degree of brace, especially in patients with low-to-moderate curvature during growth. One of these exercise approaches, the Schroth technique, is primarily based on isometric muscle contraction exercises that aim to rotate, lengthen and stabilize the spine. The core component of the Schroth method is autocorrection, defined as the patient's ability to reduce spinal deformity through active postural realignment of the spine in three dimensions. Another frequently used exercise method, Pilates exercise training improves flexibility and overall physical health by emphasizing the coordination of movements associated with strength, posture, and breathing. However, the effects of these exercises in reducing curvature and related problems are controversial in the literature. Therefore, in this study, we aimed to investigate the effects of Schroth and pilates exercises on respiratory functions, functional capacity, balance, spine structure and quality of life in adolescents with idiopathic scoliosis. Thirty patients aged 10 to 18 years, with a Cobb angle between 10 and 25 degrees, will be included in the study. The subjects will be randomly divided into two groups; Schroth exercises will be applied to one group and pilates exercises will be applied to another group. All participants will participate in exercise sessions of 60 minutes a day, 3 days a week, for 8 weeks. Each participant will receive a total of 24 sessions of exercise therapy under the supervision of a physiotherapist. In this study, exercises that activate the muscle groups responsible for maintaining the correct posture and correcting the curvature will be selected for practice. Within the study, axial trunk rotation with a scoliometer, respiratory functions and respiratory muscle strength measurement with spirometry, functional capacity with the 6-minute walking test, balance with the Tecnobody balance measuring device, quality of life with Scoliosis will be assessed by the Research Society-22 Quality of Life Questionnaire. The results obtained from the study are of great importance as they will help to determine the effects of Schroth and pilates exercises on spinal deformity and the treatment of related problems in patients with AIS and to establish appropriate programs for the prevention and treatment of these problems.

Participants needed: 30
Trial details
Age: 10-18Biological sex: AllType: InterventionalSponsor: Izmir Katip Celebi UniversityUpdated: Jun 24, 2025Locations: 2
Eligibility criteria

having a Cobb angle between 10 and 25 degrees [+1]

Presence of secondary scoliosis (congenital, muscular and neurological scoliosis... [+4]

Status: Recruiting

Minimally Invasive Surgery vs Standard Posterior Approach in the Treatment of Developmental Idiopathic Scoliosis

This is a randomized trial with 1:1 allocation. The aim of the study is to evaluate clinical and radiographic outcomes in patients with developmental age idiopathic scoliosis treated with mini invasive scoliosis surgery (MIS) technique versus posterior spinal fusion (PSF) technique through clinical and radiographic evaluations.

Participants needed: 126
Trial details
Age: 12-25Biological sex: AllType: InterventionalSponsor: Istituto Ortopedico RizzoliUpdated: Jun 4, 2025Locations: 1
Eligibility criteria

Patients with AIS [+4]

Patients already treated surgically for scoliosis; [+6]

Status: Recruiting

Preoperative Carbohydrate Drink in Adolescent Idiopathic Scoliosis Surgery: the Impact on Safety and Enhanced Recovery

The goal of this interventional study is to learn if carbohydrates loading improves overall outcome in adolescent patient undergoing scoliosis curgery The main questions of the study are as follows: 1. Does carbohydrates loading improves gastrointestinal related problems such as improvement in return of bowel function measured by first passage of flatus, reduce constipation by patient's time to first bowel opening and reduce incidence of post post operative nausea and vommiting 2. Does carbohydrates loading reduces length of hospital stay and patient's overall condition in term of anxiety, thirst and hunger 3. Does carbohydrates loading affects gastric residual volume by measuring residual gastric volume with ultrasound

Participants needed: 60
Trial details
Age: 10-19Biological sex: AllType: InterventionalSponsor: University of MalayaUpdated: May 11, 2025Locations: 2
Eligibility criteria

Patient diagnosed with idiopathic scoliosis undergoing single-staged posterior s... [+2]

Patient diagnosed with diabetes mellitus (either type I or type II) [+3]

Status: Not yet recruiting

Detecting and Monitoring Scoliosis Without Radiography: Standard Radiographic Monitoring Program Versus Self-Screening with Momentum SpineTM

The goal of this clinical trial is for the Momentum SpineTM application to accurately detect scoliosis progression, including accuracy, margin of error, sensitivity, specificity, AUC, and overall agreement with radiographs in 8-18 year olds with adolescent idiopathic scoliosis. The main question it aims to answer \[is/are\]: * Based on previous data it is hypothesize that Momentum SpineTM imaging software will be able to accurately detect scoliosis progression (\>= 7 degrees), including accuracy, margin of error, sensitivity, specificity, AUC, and overall agreement with radiographs. * Based on the above hypothesis that Momentum SpineTM is able to accurately detect scoliosis and curve progression (\>= 7 degrees). * It is hypothesized there will be indications for accelerated clinical visits based on at home detection of progression, and that these visits will be accurate and necessary. * It is hypothesized that there will be a proportion of standard care visits that are deemed unnecessary, and that the application is able to accurately predict these visits. Participants will: * Use Momentum SpineTM assessment from home to perform body scans at 1-month intervals on personal device and during the clinical visit. * Received monthly scans that will be evaluated by the provider using the application. * Receive additional scans as warranted. * Complete net promoter score (NPS) within the application following completion of a body scan. * Complete a patient satisfaction survey following 6 months of application usage.

Participants needed: 100
Trial details
Age: 8-18Biological sex: AllType: InterventionalSponsor: Children's Hospital Los AngelesUpdated: Mar 4, 2025
Eligibility criteria

Children between the ages of 8-18 years of age [+4]

Participants who have had x-rays in a brace will not be included. [+5]

Status: Not yet recruiting

Postoperative Steroid Use in Adolescent Idiopathic Scoliosis and Neuromuscular Scoliosis Patients

The goal of this randomized clinical trial is to compare the immediate use of steroids after surgery for accelerated discharge in adolescent idiopathic scoliosis and neuromuscular scoliosis after a posterior spinal fusion. The main question it aims to answer are: * What are the effects of using steroids immediately after surgery in decreasing opioid use and helping early mobilization(movement)? * Does post-operative steroid use affect the incidence of wound complications and are there any long-term impacts on scar formation? Participants will: * Fill out a Patient-Reported Outcomes Measurement Information System (PROMIS) survey specifically for pain interference and physical activity observing health related quality of life at enrollment, 3 months, 1 year, and 2 years * Have clinical photos of their incision at 3 months, 1 year, and 2 years * Their photos will be assessed using the stony book scar evaluation scale * For treatment of their scoliosis, patients will undergo a posterior spinal fusion (PSF) per standard of care, however whether the participant receives or does not receive steroids is what the investigators are trying to understand. * Researchers will compare no immediate postoperative steroid (NS) to the group with immediate postoperative steroid (WS) group to see if there are changes in opioid use, wound complications, scar formation, and facilitation in early mobilization.

Participants needed: 100
Trial details
Phase: Phase 4Age: 9-18Biological sex: AllType: InterventionalSponsor: Children's Hospital Los AngelesUpdated: Mar 5, 2025Locations: 1
Eligibility criteria

Prior instrumentation or spine surgery [+7]

Status: Recruiting

Central Motor Mechanisms in AIS Via HD-sEMG, EEG and Neuromuscular Coupling Analysis

1. Verifying the Motor Control Effects of Spinal Manipulation on AIS Using outpatient and inpatient AIS patients from our department as the study subjects, standardized spinal manipulation treatment is applied. The efficacy is evaluated through a combination of clinical outcome measures, HD-EMG for paraspinal muscle function assessment, and Pro-Kin balance system for trunk stability analysis. This establishes an AIS efficacy platform to further clarify the effectiveness of spinal manipulation in motor control regulation of AIS. 2. Investigating the Central Motor Network's Response to Spinal Manipulation in AIS Utilizing high-density sEMG-EEG technology, synchronized brain and muscle electrical signals are collected before and after treatment. By employing a neuromuscular synchronization and coupling analysis approach that integrates linear and nonlinear methods, the characteristic indices of information interaction between the central system and muscles are identified. This further explores the motor control and response characteristics of the muscle-cortex network to spinal manipulation in AIS.

Participants needed: 40
Trial details
Age: 10-18Biological sex: AllType: ObservationalSponsor: The First Affiliated Hospital of Zhejiang Chinese Medical UniversityUpdated: Jan 3, 2025Locations: 1
Eligibility criteria

Patients aged ≥10 years; [+5]

Those who do not meet the diagnostic criteria for AIS or inclusion criteria; [+4]

Status: Recruiting

Determining Best Indications for Bracing for Adolescent Idiopathic Scoliosis

This is a prospective study for Investigating the cost-effectiveness of current bracing protocols for adolescent idiopathic scoliosis (AIS). It is hypothesized that aggressive management of adolescent idiopathic scoliosis (AIS) including early bracing at mild curve magnitudes and surgery at 40 degrees is more cost-effective while maintaining similar health quality of life. Scoliosis Research Society 22-item and EuroQol- 5 dimension questionnaires and direct/indirect medical costs will be utilized for the cost-effectiveness analysis and health related quality of life assessment. The findings of this study have the potential to improve decision-making and revolutionize care of AIS patients in Hong Kong and globally. Clinicians will be able to utilize our results to provide the best and most cost-effective timing for initiating brace treatment.

Participants needed: 700
Trial details
Age: 10-18Biological sex: AllType: ObservationalSponsor: The University of Hong KongUpdated: Dec 6, 2024Locations: 2
Eligibility criteria

Patients who are diagnosed with adolescent idiopathic scoliosis and are seen in...

Patients whose diagnosis is not adolescent idiopathic scoliosis, unable to compl...

Status: Recruiting

3D Depth Camera-Based Assessment of Adolescent Idiopathic ScoliosisUsing a Depth Camera

Adolescent Idiopathic Scoliosis (AIS) is a common spinal deformity affecting adolescent health, and early diagnosis and accurate assessment are crucial for preventing disease progression. Traditional assessment indicators, such as the trunk rotation angle (ATR) and Cobb angle, rely on clinical examinations and X-ray imaging, which have certain limitations, including radiation exposure and insufficient sensitivity. The Back Height Difference (BHD), as a quantitative measure of the back surface morphology, may reflect the degree of trunk deformity caused by scoliosis. The use of the Kinect v2 depth camera to capture three-dimensional point cloud data of the back provides a high-precision, radiation-free assessment method.

Participants needed: 80
Trial details
Age: 10-18Biological sex: AllType: ObservationalSponsor: The First Affiliated Hospital of Zhejiang Chinese Medical UniversityUpdated: Dec 5, 2024Locations: 1
Eligibility criteria

Not listed

Status: Recruiting

Posterior Column Spinal Osteotomies in the Treatment of Adolescent Idiopathic Scoliosis

Background: Posterior column osteotomies (PCO) are routinely used to facilitate curve correction in surgical treatment of adolescent idiopathic scoliosis (AIS). Data regarding routine use of PCO is controversial, with conflicting data for coronal and sagittal plane correction and clinical benefit. Use of PCO has not been studied in the surgical treatment of AIS in a prospective randomized clinical trial. Study Design: A randomized, multicenter clinical trial on children and adolescents undergoing posterior spinal fusion for idiopathic scoliosis using pedicle screw instrumentation. Sixty consecutive adolescents will be randomized into PCO or no PCO group after surgical exposure of the spine in 1:1 ratio. Aims and Hypothesis: To compare PCO vs. no PCO groups for the correction of coronal and sagittal plane curve in children undergoing posterior spinal fusion for AIS. The investigators hypothesize that the correction of coronal curve and hypokyphosis will be better in PCO group without increasing blood loss or complications. Inclusion criteria: Adolescents (aged 10 to 21 years of age) undergoing corrective surgery for idiopathic scoliosis using pedicle screw technique. Exclusion criteria: Coagulation disorder, smoking, unwilling to consent, vertebral column resection, need for anteroposterior surgery. Main outcome parameters: Primary outcome is the radiographic correction (Coronal and sagittal plane). Secondary outcomes include health-related quality of life (Scoliosis Research Society 24 outcome questionnaire), postoperative pain, rib hump, operative time, blood loss, hospital stay, and complications. Ethical aspects: Ethical committee approval will be obtained. An informed consent will be obtained from all children and their parents. Time schedule and budget: This study has ethical committee approval.There will be no extra costs as all information gathered will be part of normal surgical treatment of AIS. A part-time research nurse has been hired to take care of data collection into the database.

Participants needed: 90
Trial details
Age: 10-21Biological sex: AllType: InterventionalSponsor: Turku University HospitalUpdated: Dec 3, 2024Locations: 2
Eligibility criteria

Adolescent idiopathic scoliosis (Lenke 1 to 4) [+3]

Anteroposterior surgery [+4]

Status: Recruiting

Clinical Effectiveness of Intervertebral Disc Release in Treating Lenke 5 Adolescent Idiopathic Scoliosis

Adolescent idiopathic scoliosis (AIS) poses challenges in achieving optimal three-dimensional correction. While posterior fusion with pedicle screws has shown success, osteotomy techniques, such as Ponte osteotomy, have further improved outcomes. However, residual vertebral rotation remains a concern, impacting long-term complications. Intervertebral disc release (IDR) presents a potential solution to enhance derotation and reduce fusion levels, particularly in Lenke Type 5 AIS. This prospective randomized controlled trial aims to evaluate the clinical effectiveness of IDR in treating Lenke 5 AIS, comparing it to Ponte osteotomy. The study focuses on axial vertebral rotation correction, coronal curve improvement, blood loss, hospital stay, and adverse events. Participants aged 10-18 with Lenke 5 AIS will undergo either IDR or Ponte osteotomy, randomly assigned. Outcome measures include axial rotation correction rate, radiographic parameters, and clinical assessments. A total of 132 participants will be recruited. The IDR technique, through posterior disc removal, presents a promising approach to optimize derotation in Lenke 5 AIS. While offering potential advantages, challenges like limited working space and bleeding risks require careful consideration. The study's findings aim to provide robust clinical evidence, enhancing treatment strategies for Lenke 5 AIS and offering innovative approaches for AIS as a whole.

Participants needed: 132
Trial details
Age: 10-18Biological sex: AllType: InterventionalSponsor: Peking Union Medical College HospitalUpdated: Oct 21, 2024Locations: 1
Eligibility criteria

Between the ages of 10 and 18 [+2]

A history of previous corrective surgery [+2]

Status: Recruiting

Dynamic Pressure Monitoring System for Orthotic Treatment of Scoliosis

Adolescent idiopathic scoliosis (AIS) involves three-dimensional spinal deformity in children aged between 10 and 16. Traditional braces modify the natural dynamics and thus the mechanical behaviour of the scoliotic spine through external constraints. Patients usually develop pressure ulcers and skin irritation when prescribed brace treatment for 18-23 hours per day. The excessive pressure, unknown pressure distribution and pressure shifting between the human body and the brace causes the effects of brace treatment to be unpredictable. Dynamic pressure monitoring system will be developed based on the body landmarks of scoliotic patients and critical areas where active pressure is applied by the brace. The overall pressure distribution and dynamic pressure between the body and the thoraco-lumbo-sacral orthosis (TLSO) rigid brace will be measured. The efficacy of the brace design will be evaluated, and the maximum compressive stresses that patients can endure on different body parts without pressure injury can be computed.

Participants needed: 20
Trial details
Age: 10-15Biological sex: AllType: ObservationalSponsor: The Hong Kong Polytechnic UniversityUpdated: Oct 18, 2024Locations: 1
Eligibility criteria

Teenagers diagnosed with adolescent idiopathic scoliosis [+4]

Contraindications for x-ray exposure [+6]

Status: Recruiting

3D Imaging Assessment of Scoliosis: Back Height Difference vs. Trunk Rotation Angle

This study focuses on adolescents with idiopathic scoliosis, employing 3D imaging technology with depth cameras to measure back height difference (BHD) and angle of trunk rotation (ATR) before and after conventional treatments such as massage, exercise therapy, and bracing. Statistical analyses are conducted to verify the correlation between BHD and ATR and to assess the sensitivity of BHD in evaluating short-term treatment effectiveness.

Participants needed: 80
Trial details
Age: 10-18Biological sex: AllType: ObservationalSponsor: The First Affiliated Hospital of Zhejiang Chinese Medical UniversityUpdated: Oct 16, 2024Locations: 1
Eligibility criteria

Not listed

Status: Recruiting

Trials of Intelligent Nighttime Brace With Smart Padding to Treat of Adolescent Idiopathic Scoliosis

Adolescent idiopathic scoliosis (AIS) is a three-dimensional spinal deformity usually associated with intervertebral rotation that takes place during adolescence. Generally, bracing treatment is a common option for scoliosis patients. Non-surgical treatment for scoliosis patients is to offer a conservative solution to treat their condition and encourage a higher degree of compliance by avoiding interference with their daily life activities. Therefore, intelligent nighttime braces have been developed to solve this issue, which are intended to be worn for inhibiting the advancement of spinal deformity during sleeping hours. However, its efficacy is still controversial. Intelligent nighttime brace with a specialized design for teenagers with scoliosis is limited and most part of them are lack of mobility and lack of control over corrective forces on particular regions of the vertebra. A scientific approach should be used to design and develop intelligent nighttime brace as a treatment option for adolescents with early scoliosis.

Participants needed: 10
Trial details
Age: 10-13Biological sex: FemaleType: InterventionalSponsor: The Hong Kong Polytechnic UniversityUpdated: Oct 15, 2024Locations: 1
Eligibility criteria

between the ages of 10-13, [+5]

History of previous surgical or orthotic treatment for AIS [+4]

Status: Recruiting

Non Fusion Surgery in Adolescent Idiopathic Scoliosis Patients

The primary objective of the study is to monitor the effectiveness of a minimal invasive non-fusion double rod bipolar posterior spinal implant (Nemost growing domino) to correct the scoliotic curve in growing patients suffering from progressive adolescent idiopathic scoliosis (AIS) who have failed conservative treatment.

Participants needed: 18
Trial details
Age: 10-17Biological sex: AllType: InterventionalSponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Updated: Jul 30, 2024Locations: 1
Eligibility criteria

Adolescent idiopathic scoliosis ; [+8]

Non-idiopathic scoliosis: musculoskeletal or neurologic conditions responsible f... [+8]