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NCT ID: NCT03863496 Completed - Clinical trials for Neuromuscular Diseases

Efficacy of Surgical Treatment by Different Pedicle Screw Systems in Pediatric Neuromuscular Spinal Deformity

Start date: January 31, 2018
Phase: N/A
Study type: Interventional

This study was sponsored by Federal state budgetary institution "Russian scientific center for traumatology and orthopedics" n.a. acad. G.A. Ilizarov" of the Ministry of Health of Russian Federation. The study will take place at this center. It is expected to enroll 70 patients aged 6-25 years with NMD, all of whom will be subjected to thoracic and lumbar spinal deformity surgery. Patients will be divided into two groups depending on skeletal maturity. The degree of skeletal maturity will be determined on the basis of an X-ray study of spinal and pelvic bones. The type of surgical correction will depend on the group.

NCT ID: NCT03862625 Completed - Cerebral Palsy Clinical Trials

Seating System for Scoliosis in Non-ambulatory Children With Cerebral Palsy: A Pilot Randomized Controlled Trial

Start date: April 10, 2016
Phase: N/A
Study type: Interventional

The effect of a modular seating system on coronal and sagittal balance of the spine and pelvic obliquity in children with non-ambulatory (Gross Motor Function Classification System Level IV-V) and scoliosis The hypothesis in our study is; a modular adaptive seating system prevents the progression of spinal curvature and Reimer's maturation index, improves the sagittal balance of the spine and pelvic obliquity.

NCT ID: NCT03843216 Completed - Clinical trials for Scoliosis Idiopathic

End Growth Results for Conservative Treatment for Idiopahitc Scoliosis

Start date: January 2016
Phase:
Study type: Observational

This study evaluates in a prospectively collected multicenter cohort the existence, characteristics and determinants of EBPCA, the obtained results and their determinant, the rate of over- and under-treatment and their determinants.

NCT ID: NCT03835390 Completed - Clinical trials for Scoliosis Idiopathic Adolescent

SIMDiscovery: The Benefits of Utilizing a Simulation Preparation Program for Spinal Fusion Surgery

Start date: February 22, 2019
Phase: N/A
Study type: Interventional

This is a pilot study aiming to examine preliminary effectiveness of a preparation program which includes simulation (SIMDiscovery) in reducing anxiety and increasing feelings of preparedness among parents and their children who will undergo spinal fusion surgery. SIMDiscovery is an experiential learning preparation program which aims to educate children and families about different medical procedures through simulation play.

NCT ID: NCT03823053 Completed - Clinical trials for Adolescent Idiopathic Scoliosis

The Effect of the Core Stabilization Training on Respiratory Parameters , Functional Capacity and Balance in Scoliosis

Start date: February 25, 2019
Phase: N/A
Study type: Interventional

The vertebral column is a structure that transfers the weight of the head and torso to the lower extremity, provides trunk movements and protects the spinal cord.A three dimensional deformity involving lateral flexion of the vertebrae in the frontal plane at 10 ° and above, including axial rotation and physiologic flexion (hypokyphosis) components in the sagittal plane, is defined as scoliosis. Adolescent idiopathic scoliosis (AIS) is a type of idiopathic scoliosis that occurs in the period from the onset of puberty (up to 10 years) until the closure of growth plates. Scoliosis is caused by postural, balance and neuromotor disorders as a primary cause of impaired sensory integrity, proprioceptive feedback deficits, secondary lung problems, organ disorders and pain. In addition, the quality of life in these individuals is also seen to decrease.Children with adolescent idiopathic scoliosis have inadequate respiratory function and a decrease in functional capacity. At the same time, these children show muscle weakness in certain parts of the body. The aim of this study was to investigate the relationship between home based core stabilization training, respiratory parameters, peripheral muscle strength, balance, functional capacity and quality of life in individuals with young scoliosis. The investigators suggest that the addition of core stabilization training to children with mild and moderate adolescent idiopathic scoliosis will produce good results.

NCT ID: NCT03820895 Completed - Clinical trials for Vitamin D Deficiency

Vitamin D Levels in Adolescent Idiopathic Scoliosis

Start date: October 1, 2016
Phase:
Study type: Observational

This study aims to estimate the prevalence of vitamin D insufficiency among patients with adolescent idiopathic scoliosis, to calculate the differences in serum vitamin D levels, Cobb angles, spinal bone mass densities, and serum alkaline phosphatase levels between genders in the sample, and to assess the possibility of a correlation between any of these factors in those surgical patients.

NCT ID: NCT03814239 Completed - Scoliosis Clinical Trials

Blood and Fluid Management During Scoliosis Surgery

Start date: October 30, 2011
Phase:
Study type: Observational

In the present retrospective study, it was hypothesized that application, in scoliosis surgery, of a protocol for blood and fluid management, based on goal directed fluid therapy, cell salvage and tranexamic acid, could lead to reduced allogeneic red blood cells transfusion. The patients will be enrolled in a retrospective observational study and divided in two groups. Patients in no protocol Group received a liberal intraoperative fluid therapy and patients in protocol Group received fluid therapy managed according to a stroke volume variation based protocol. The protocol included fluid therapy according to SVV monitor, permissive hypotension, tranexamic acid infusion, restrictive RBC trigger and use of perioperative cell savage.

NCT ID: NCT03779581 Completed - Clinical trials for Scoliosis Idiopathic

Self Correction Exercises for Idiopathic Scoliosis Among Adolescents. A Randomised Controlled Trial

Start date: January 1, 2018
Phase: N/A
Study type: Interventional

Adolescent idiopathic scoliosis (AIS) is a three-dimensional spinal deformity with an unknown cause that affects adolescents aged 10 or older. A standing posterior-anterior radiograph with a Cobb angle greater than 10 degrees is used to make the diagnosis. Depending on the severity of the spinal deformity, conservative treatments and surgery are used to treat AIS. Patients whose spinal curvature is greater than 45 degrees are typically considered for surgery. The majority of patients with AIS receive conservative treatments to prevent and slow the progression of the curve. 2 Orthotic intervention (OI) and scoliosis-specific exercise (SSE) are commonly recommended by the International Society on Scoliosis Orthopaedic and Rehabilitation Treatment for patients with a curvature between 20 and 45 degrees. Self correction exercises are the group of spinal extension, lateral spinal flexion and rotational exercises performed to correct spinal deviation. Exercises are performed in a different fundamental postures.

NCT ID: NCT03773458 Completed - Scoliosis Clinical Trials

Validation of the Utility of an Artificial System for the Large-scale Screening of Scoliosis

Start date: June 1, 2018
Phase: N/A
Study type: Interventional

Traditional school scoliosis screening approaches remains debatable due to unnecessary referal and excessive cost. Deep learning algorithms have proven to be powerful tools for the detection of multiple diseases; however, the application of such methods in scoliosis screening requires further assessment and validation. Here, the investigators develop an artificial system for the automated screening of scoliosis using disrobed back images, and conduct clinical trial to validate if the diagnostic system can offsetting the shortcomings of human doctors.

NCT ID: NCT03729947 Completed - Clinical trials for Adolescent Idiopathic Scoliosis

CLOSED SUCTION DRAIN VS. NO DRAIN IN ADOLESCENTS UNDERGOING PEDICLE SCREW INSTRUMENTATION FOR IDIOPATHIC SCOLIOSIS (DAISY 2018). A Randomized Clinical Trial

DAISY 2018
Start date: November 1, 2018
Phase: N/A
Study type: Interventional

Abstract Background - Closed suction drain is typically used worldwide after instrumented posterior spinal fusion for adolescent idiopathic scoliosis (AIS). Postoperative drain leakage has been associated with up to 50% of total blood loss in these patients. Previous studies on adult patients with degenerative lumbar spine disorders have shown that leaving out subfascial drain does not increase the risk of deep wound infection or epidural hematoma. However, there has been no studies evaluating the need for subfascial drain in adolescents undergoing instrumented spinal fusion for idiopathic scoliosis. Study Design - A randomized, multicenter clinical trial on children and adolescents undergoing posterior spinal fusion for idiopathic scoliosis using pedicle screw technique. Ninety consecutive adolescents will be randomized into drain vs. no drain group at the time of wound closure using the sealed envelope technique (1:1). Aims and hypothesis - To compare drain vs. no drain use groups for the change in postoperative hemoglobin or hematocrit in children undergoing posterior spinal fusion for AIS. We hypothesize that postoperative hemoglobin change will be larger in the group receiving subfascial drain and there will no change in the risk of postoperative complications (deep surgical site infection, need for hematoma evacuation or other re-operation) between the study groups. Inclusion criteria - Adolescents (aged 10 to 21 years of age) undergoing 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 parametres - Postoperative change in hemoglobin or hematocrit; Secondary parametres: need for blood transfusion, need for re-operation, need for change in the dressings. Ethical aspects - Ethical committee approval will be obtained both in Finland and in Sweden. An informed consent will be obtained from all children and their parents. In case of major intraoperative blood loss (>50% of blood volume) a subfascial drain can be inserted based on the decision of the treating physician. Time schedule and budget - This study will be started after ethical committee approval (estimated 10/2018). 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.