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Spinal Fractures clinical trials

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NCT ID: NCT05608460 Recruiting - Clinical trials for Cervical Spine Fracture

Pediatric Cervical Spine Clearance: A Multicenter Prospective Observational Study

Start date: August 15, 2022
Phase:
Study type: Observational [Patient Registry]

A prospective multicenter observational study, led by Dr. Katie Russell of Intermountain Primary Children's Hospital, that will examine the sensitivity, specificity, negative, and positive predictive values of CT scan and plain films in diagnosing cervical spine injury that requires treatment. This study is funded by the Primary Children's Hospital foundation.

NCT ID: NCT05521724 Recruiting - Vertebral Fracture Clinical Trials

Osteoporotic Vertebral Fractures and Exercise

Start date: August 20, 2022
Phase: N/A
Study type: Interventional

Physiotherapy has an important place in the treatment of osteoporotic vertebral fractures. Therapeutic exercise is often recommended for patients with vertebral fractures to reduce pain and restore functional movement. There is not enough evidence in the literature to determine the effects of long-term exercise on osteoporotic fractures and their side effects. Therefore, the aim of this study is to evaluate the effectiveness of 12-week exercise training in patients with osteoporotic vertebral fractures.

NCT ID: NCT05519332 Recruiting - Clinical trials for Osteoporotic Fracture of Vertebra

Percutaneous Vertebral-disc Plasty for Thoracolumbar Very Severe Osteoporotic Vertebral Compression Fractures

Start date: March 1, 2020
Phase: N/A
Study type: Interventional

Purpose: To compare the clinical outcomes and radiological parameters of patients undergoing percutaneous vertebroplasty (PVP) versus those undergoing percutaneous vertebral-disc plasty (PVDP) for back pain, segmental instability, and kyphosis due to thoracolumbar very severe osteoporotic vertebral compression fractures (vsOVCFs). This prospective study included elderly patients with thoracolumbar vsOVCFs. All the patients were randomly allocated into the PVP group (who underwent conventional PVP) and the PVDP group (who underwent PVP combined percutaneous cement discoplasty). The visual analogue scale (VAS), Oswestry Disability Index (ODI), local kyphosis angle, and disc height were recorded preoperatively and postoperatively.

NCT ID: NCT05296889 Recruiting - Clinical trials for Degenerative Disc Disease

Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Cervical

CERISE
Start date: July 21, 2021
Phase:
Study type: Observational

Multicenter Post market clinical follow-up Study on the Safety and Performance of Ennovate® Cervical - Prospective, pure data collection of all Ennovate Cervical patients in Total Indications

NCT ID: NCT05170815 Recruiting - Spinal Deformity Clinical Trials

Clariance ErYs Registry

ErYs
Start date: January 17, 2022
Phase:
Study type: Observational

International, prospective, single arm, multicenter and observational Post-Market Clinical Follow-up (PMCF). The overall objective of this study is to collect preoperative, intraoperative and postoperative (at 9 weeks, 6 months, 1 year and 2 years) data on the clinical complications and functional outcomes of the study devices to demonstrate safety and performance in a real-world setting. The primary objective is to demonstrate that the use of the study devices is safe. The secondary objective is to demonstrate that the use of the study devices decreases the pain, and improves the quality of life and the daily activities of the subjects.

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: 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: 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).