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Spine Deformity clinical trials

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NCT ID: NCT06223737 Not yet recruiting - Spine Deformity Clinical Trials

Spine Deformity Patients With Optoelectronic Motion Capture

Start date: June 1, 2024
Phase: N/A
Study type: Interventional

Aging-induced changes in the spine can lead to adult spinal deformity, causing a forward and/or lateral shift of the trunk. While mild cases may have compensatory mechanisms, severe deformities necessitate treatment. Surgery with instrumentation effectively corrects deformities, but complications are common. Precise pre-operative planning based on X-rays is essential. However, radiological imaging has limitations, including ionizing radiation exposure and static nature. Marker-based optoelectronic motion analysis systems offer potential benefits for dynamic spine assessment. This study aims to test the feasibility of using motion analysis systems to characterize spinal alignment and balance in patients with adult spine deformity. The primary objective is to assess the practical implementation, measurement capability, and resources required for motion analysis. Secondary objectives include investigating errors in absolute spinal curvature assessment and developing compensation strategies. The project will recruit 20 patients (non-operated and operated) seeking medical attention for adult spine deformities and 10 healthy controls. Participants will undergo biplanar imaging and motion analysis to capture static and dynamic spine alignment during common activities. The data will help build patient-specific musculoskeletal models, offering potential insights into improving surgical planning for adult spine deformities.

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 - Sacroiliitis 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: NCT05244031 Completed - Postoperative Pain Clinical Trials

Intraoperative Placement of Superficial Erector Spinae Plane Block; A New Approach in Spine Surgery

Start date: May 10, 2021
Phase: N/A
Study type: Interventional

Major spine surgery causes severe postoperative pain. The primary objective of this randomized controlled study is to compare the effect of ultrasound (US)-guided superficial erector spinae plane (ESP) block on 48-hour postoperative cumulative opioid requirements with standard (opioid-based) analgesia.

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.

NCT ID: NCT05038527 Recruiting - Adverse Events Clinical Trials

ABM/P-15 Bone Graft vs Traditional Bone Graft in Adult Spinal Deformity Surgery

Start date: October 1, 2021
Phase: N/A
Study type: Interventional

The purpose of this prospective trial is to investigate ABM/P-15 bone graft versus traditional bone graft in patients undergoing surgery for Adult Spinal Deformity (ASD) in order to provide better clinical results through faster bone healing, no additional surgeries, fewer complications and thereby increase health-related quality of life. Main hypotheses: 1. The use of ABM/P-15 bone graft is superior to traditional bone graft treatment regarding the incidence of additional surgeries following index surgery for ASD Secondary hypotheses: 2. The investigators expect non-inferiority in patient reported outcome measures in the ABM/P-15 bone graft group compared to the control group 3. The investigators expect non-inferiority in the postoperative fusion rates (bone healing) evaluated on CT scans in the ABM/P-15 bone graft group compared to the control group 4. The investigators expect non-inferiority in postoperative incidence of asymptomatic pseudarthrosis in the ABM/P-15 bone graft group compared to the control group 5. The investigators expect non-inferiority in perioperative complications in ABM/P-15 bone graft group compared to the control group 6. The investigators expect the use of ABM/P-15 bone graft to be cost-efficient compared to the traditional treatment in the control group