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Spine Deformity clinical trials

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NCT ID: NCT06443398 Recruiting - Cerebral Palsy Clinical Trials

Spine of Caregivers of Children With Cerebral Palsy

Start date: January 31, 2024
Phase:
Study type: Observational

The purpose of this study was to assess pain (rest, activity, and night pain using the Visual Analog Scale), disability (neck using the Neck Disability Index; lumbar using the Oswestry Disability Index), and curvature (cervical, thoracic, and lumbar using the Spinal Mouse) in primary caregivers of children with cerebral palsy.

NCT ID: NCT06418334 Recruiting - Spine Deformity Clinical Trials

Ultrasonographic Measurement of Diaphragmatic Thickness in Adolescents With Thoracal Hyperkyphosis

Start date: October 1, 2023
Phase:
Study type: Observational

Spinal deformity is common in childhood and adolescence. Any spinal deformity, especially one that affects the thoracic spine, can affect lung function.The diaphragm is the main respiratory muscle, and diaphragm contraction is associated with respiratory functions. The investigators aimed to measure the diaphragmatic thickness in adolescents with increased thoracal kyphosis (thoracal hyperkyphosis) deformities.

NCT ID: NCT06417944 Recruiting - Scoliosis Clinical Trials

The Effect of Three-dimensional Exercise (Schroth Exercise) on Diaphragm Thickness in Adolescent Idiopathic Scoliosis Patients

Start date: May 14, 2024
Phase:
Study type: Observational [Patient Registry]

Spinal deformity is common in childhood and adolescence, and can often present as scoliosis or increased thoracic kyphosis deformity with various etiologies.The diaphragm is the main respiratory muscle, and diaphragm contraction is associated with respiratory functions.Any spinal deformity, especially one that affects the thoracic spine, can affect lung function.In the planned thesis study, investigators will measure the diaphragm thickness in adolescent idiopathic scoliosis patients with scoliosis deformities affecting the thoracic region, whether there is any relationship between the impact in the thoracic region and the diaphragm thickness, and the three-dimensional exercise (Schroth exercise-Barcelona Schroth therapy) applied in investigators' clinic for scoliosis, before and after the treatment of the diaphragm. Investigators aimed to show whether there is any change in thickness.

NCT ID: NCT06144879 Recruiting - Spine Deformity Clinical Trials

Novel Pedicle Screws Used for Corrective Surgery in Spinal Deformity

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

There are still a large number of severe spinal deformity cases which would keep progressing without treatment. These patients not only have severe appearance deformity, but also suffer from cardiopulmonary compression, reduced abdominal volume, and even spinal cord injury. It is crucial to provide safe and effective surgical intervention for these patients. The corrective surgery with 3-column osteotomy is reported to be an effective surgical strategy for severe spinal deformity. However, due to the great corrective stress on the rods, there is an increased number of patients requiring revision surgery due to rod fracture (3.7%-15%). In patients with 3-column osteotomy, the osteotomy area and the upper and lower adjacent segments are mostly stress-concentrated areas, and the rod is prone to fatigue fracture. Therefore, it is necessary to reinforce the osteotomy area and adjacent segments to reduce the risk of rod fracture. Our previous study found the risk of rod fracture could be reduced by using satellite rods with duet connectors or dominos. However, in the traditional satellite rod technology, the connection of the main rod and the satellite rod rely on the traditional single slot screw and duet connectors. The two are separated and not a whole in the mechanical structure. The stability of the fixation is relatively insufficient, and stil deserves room for improvement. Based on the traditional duet connectors, we further invent a novel dual-headed pedicle screw, which is an combination of traditional single slot screw and duet connector. Compared with the traditional duet connector, the novel dual-headed pedicle screw theoretically has stronger stability between the main rod and satellite rod, due to its integration of screw and connector. Hence, the purpose of this study is to verify the strong stability of the novel dual-headed screw by biomechanical study in cadavers performed with long spinal fusion (T12-pelvis) with L3 pedicle subtraction osteotomy (PSO). And to further investigate its effectiveness in severe adult spinal deformity patients receiving corrective surgery with PSO. If the biomechanical properties and clinical effects of the novel dual-headed screw have been confirmed, the promotion of the product has great prospects in the world. The severe spinal deformity patients would benefit from this study when they receive spinal corrective surgery with 3-column osteotomy, using satellite rods technology by this novel dual-headed screw.

NCT ID: NCT05995327 Recruiting - Spine Deformity Clinical Trials

Reasons and Risk Factors for Unplanned Spinal Re-operation

Start date: January 1, 2012
Phase:
Study type: Observational

Unplanned re-operation is one of the common negative indicators reflecting the quality and safety of surgery in the medical industry and has become one of the ten goals for the improvement of national medical quality and safety in China since 2022, while about 40% of unplanned re-operations in Peking University Third Hospital in recent years occur in spine patients of the orthopedics department. This project intends to establish a high-quality and sustainable ambispective disease cohort for spine surgery in Peking University Third Hospital based on the unplanned re-operations that occurred in the Orthopedics Department of Peking University Third Hospital from January 2012 to December 2025. The investigators further summarize and analyze clinical causes and risk factors of re-operations, aiming to explore scientific coping strategies and provide reference for continuous improvement of medical service quality.

NCT ID: NCT05866419 Recruiting - Scoliosis Clinical Trials

Study of an Intrathecal Port and Catheter System for Subjects With Spinal Muscular Atrophy

PIERRE
Start date: November 27, 2023
Phase: N/A
Study type: Interventional

The primary objective of the clinical investigation is to demonstrate successful clinical use of the ThecaFlex DRx™ System in delivering nusinersen in subjects with spinal muscular atrophy (SMA). All enrolled subjects will undergo implantation of the investigational device (ThecaFlex DRx™ System) and will be followed for 12 months after receiving the implant. The 12-month data will be used to assess the primary endpoint support a Pre-Market Approval (PMA) application.

NCT ID: NCT05391412 Recruiting - Bleeding Clinical Trials

Effect of Prophylactic Fibrinogen Concentrate In Scoliosis Surgery

EFISS
Start date: June 6, 2022
Phase: Phase 4
Study type: Interventional

EFISS is a prospective, randomized, placebo-controlled trial testing the feasibility, safety and efficacy of prophylactic administration of fibrinogen in paediatric spinal surgery. The study is monocentric and will be conducted in University Hospital Brno, Czech Republic. This is a pilot study in which the primary objective will be to evaluate the feasibility of a clinical trial in 32 selected patients undergoing scoliosis surgery. Participants will be randomized into study groups in a 1:1 allocation ratio and followed up for 28 days after surgery. The expected duration of this clinical trial is 8 months.

NCT ID: NCT05276024 Recruiting - Spine Deformity Clinical Trials

Evaluation of the iFuse Bedrock Technique in Association With Posterior Lumbosacral Fusion With Iliac Fixation.

Start date: June 10, 2022
Phase:
Study type: Observational

The purpose of this study is to describe the impact of the iFuse Bedrock technique to decrease post-operative pains in patients who underwent multilevel posterior lumbosacral fusion.

NCT ID: NCT05154825 Recruiting - Spine Deformity Clinical Trials

Evaluating and Establishing the Relationship in the Five Critical X-ray Time Points in Spinal Deformity Realignment

Start date: December 7, 2021
Phase:
Study type: Observational

To establish the relationship in the five critical X-ray time points during multilevel posterior column osteotomies (MPCO) spinal deformity realignment in patients with adult spinal deformity and to follow the participants longitudinally to examine any follow-up X-rays and clinical data to compare to the post-operative standing scan and pre-operative data.

NCT ID: NCT05071144 Recruiting - Clinical trials for Adolescent Idiopathic Scoliosis

Spine Procedures Assisted With RoboTics And Navigation

SPARTAN
Start date: December 13, 2021
Phase:
Study type: Observational [Patient Registry]

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