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Spinal Fractures clinical trials

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NCT ID: NCT05010135 Recruiting - Balance Clinical Trials

Evaluation of Balance and Gait Weight Distribution in Patients With Vertebral Column Fractures

Start date: January 25, 2021
Phase:
Study type: Observational

Vertebral column fracture presents a significant warning of subsequent osteoporotic fracture and frequent falls. The presence of an osteoporotic vertebral fracture is also a predictor of further risk of vertebral and other osteoporotic fractures. This study provides balance assessment and gait evaluation for subjects with a known vertebral fracture. Subjects are the known cases of vertebral fracture living in the community. They will be assessed for their balance and gait weight distribution by the TechnoBody for their balance ability, and the Zebris Gait System for the gait weight distribution. The Humac Norm for the lower limb muscle strength.

NCT ID: NCT04980131 Completed - Vertebral Fracture Clinical Trials

Application of 3-Dimensional Printing Guide Template and Pointed Lotus-style Regulator

Start date: June 6, 2018
Phase: N/A
Study type: Interventional

This study aims to analysis the efficacy of the 3D printing percutaneous guide template in combination with the pointed lotus-style regulator in percutaneous pedicle screw fixation.

NCT ID: NCT04956588 Completed - Spine Disease Clinical Trials

Evaluation of the Safety and Efficacy of Smart Orthopedic Minimally Invasive Surgical Systems for Spinal Surgery

Start date: September 1, 2017
Phase: Phase 3
Study type: Interventional

To evaluate the safety and effectiveness of the intelligent orthopedic minimally invasive surgery system developed by Shenzhen Xinjunte Intelligent Medical Equipment Co., Ltd. in spinal surgery.

NCT ID: NCT04867577 Recruiting - Vertebral Fracture Clinical Trials

Assessement of Vertebroplasty-related Cement Leakage

Start date: April 30, 2021
Phase:
Study type: Observational [Patient Registry]

Vertebral compression fracture is a common disorder in elderly patients. Vertebroplasty or surgical fixation are therefore commonly performed, in which bone cement is injected and help to provide additional support for unstable fracture to ease the pain. Cement leakage to paraspinal vein is very common and often taken as indicator of endpoint of the procedure. However, the leaked cement entering venous system can go to right heart and cause pulmonary embolism sometimes. The prevalence and pattern of this problem is largely unknown, especially subclinical condition. In this project, we intend to perform in vivo investigation of the cement distribution under different injection conditions. We also plan to conduct a clinical study to investigate the pattern, prevalence, and risk factor of cement venous leakage and pulmonary embolism. The study is a prospective cohort design, in which we plan to recruit 60 patients who receive vertebroplasty or cemented pedicle screws fixation for vertebral compression fracture. Plain X ray and computed tomography (CT) will be performed after operation. For CT, plain CT for operated site and dual energy acquisition for pulmonary vasculature will be performed, in which the pulmonary perfusion will be detected precisely. The different modalities can help delineate of radiological pattern of cement leakage. Spine surgeon, interventional radiologist, neuroradiologist, and thoracic radiologist will participate in this project. Experience on the optimal technique for cement use under fluoroscope is expected. The knowledge obtained in this study can be used in clinical ground and translate into academic outcome and clinical patient care.

NCT ID: NCT04821739 Recruiting - Vertebral Fracture Clinical Trials

RISE - Study of the AGN1 LOEP SV Kit in Patients With Vertebral Compression Fractures

Start date: May 19, 2021
Phase: N/A
Study type: Interventional

This study is a prospective, single-arm, multi-center, European clinical study designed to evaluate the clinical performance and safety of the AGN1 LOEP SV Kit for the treatment of painful VCFs.

NCT ID: NCT04774029 Completed - Vertebral Fracture Clinical Trials

Basivertebral Nerve Block During Vertebral Augmentation: An Alternative Approach to Intraprocedural Pain Management

Start date: January 10, 2020
Phase: Early Phase 1
Study type: Interventional

The goal of this study is to assess the efficacy of lidocaine basivertebral nerve block as intraprocedural anesthesia during vertebral augmentation procedures.

NCT ID: NCT04743869 Not yet recruiting - SPINAL Fracture Clinical Trials

Calcium Phosphate Versus PMMA Cement in Thoracolumbar Fractures

CaPvsPMMA
Start date: February 2021
Phase: N/A
Study type: Interventional

Patients at the age of 50 or older presenting with thoracolumbar fractures including segments TH 6-L5 and A3/A4 fractures according to the AO Spine fracture classification after the acute trauma and planned surgery within 3 weeks following trauma will be asked to participate in a randomized trial in which they will receive either Calciumphosphate (CaP) or Polymethylmethacrylate (PMMA) as part of a standardized treatment approach. Regardless of the group patients are randomized to, all participating patients undergo the same surgical procedure except for the preparation and administration of bone cement. The study participation period for each patient is 1 year from the date of the surgery and includes 4 defined time points that include follow-up clinical visits for imaging and progress checks at 6 weeks, 3 months, 6 months and 12 months after surgery. At each follow-up visit, a combination of questionnaires and radiological imaging will be performed to assess general health status, disability level and pain control, as well as objective results of the surgery. The main outcome measure will be the loss of correction rate that will be measured through the bi-segmental COBB angle presented in the CT-scan.

NCT ID: NCT04660825 Completed - Osteoporosis Clinical Trials

Development and Evaluation of an Exercise Intervention for Prevention of Vertebral Osteoporosis and Deformity in Postmenopausal Women

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

Osteoporotic fractures of the vertebrae (bones in the back) cause substantial pain and disability. Exercise could help to prevent these fractures by increasing bone strength and improving posture. Unfortunately, not all exercises strengthen bone. Exercises that do work (e.g. heavy weight lifting) are not popular with women at risk of osteoporosis. The investigators will develop a feasible exercise programme that can be done at a community centre or at home, using resistance bands. The investigators will involve women in designing the programme and incorporate strategies to support behaviour change. The investigators will then examine whether the programme improves bone density, posture or muscle strength in eighty women. Half the women, chosen at random, will take up exercise whilst the remaining half act as a control group. The investigators will take bone scans to determine bone density, and measure spinal curvature and strength, before and after the six- month programme. Findings will be useful in making recommendations as to which types of exercise increase spine bone density and will help to design future research on maximising vertebral strength. If significant benefits are seen, the investigators will develop resources such as booklets and videos so that the intervention can be widely available.

NCT ID: NCT04609150 Recruiting - Multiple Myeloma Clinical Trials

Vertebral Fat Quantitative MRI as a Marker of Bone Fragility in Multiple Myeloma (MYELOMEFRAGIQUANTI)

Start date: November 2020
Phase:
Study type: Observational

Multiple myeloma is a disease that causes increased bone fragility which is often revealed or complicated by vertebral fractures. Invasion of bone marrow by tumor plasma cells leads to bone destruction and reduced fat fraction. The main objective is to assess the correlation between vertebral bone marrow fat fraction and bone fragility represented by a severity score of vertebral fractures. The secondary objective is to assess the correlation with clinical and biological prognostic factors and scores..

NCT ID: NCT04533217 Recruiting - Multiple Myeloma Clinical Trials

Examination of Vertebroplasty in Addition to Regular Treatment of Patients With Multiple Myeloma.

Start date: March 29, 2021
Phase: N/A
Study type: Interventional

Patients with newly diagnosed or known multiple myeloma with newly diagnosed vertebral lesion(s) will be invited to participate in a cross-sectoral randomized controlled trial. The trial will compare two groups of patients which either receive regular medical treatment of their vertebral lesion(s) or vertebroplasty in addition to regular medical treatment. Our goal is to investigate the effectiveness of vertebroplasty and determine the role of surgical treatment in the overall treatment of patients with multiple myeloma and vertebral lesion(s).