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Spinal Fractures clinical trials

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NCT ID: NCT04064437 Completed - Clinical trials for Diabetes Mellitus, Type 1

Prevalence of Vertebral Fractures in Patients With Type 1 Diabetes

DenSiFy
Start date: July 29, 2019
Phase:
Study type: Observational

Background : Type 1 diabetes is associated with an increased risk of fractures. The mechanisms accounting for this bone fragility are not yet fully understood. The lower bone mineral density (BMD) observed in individuals with type 1 diabetes cannot solely explain the higher fracture incidence. Bone microarchitecture defects significantly contribute to bone fragility. Few studies assessed spine fractures in type 1 diabetes. This cross-sectional multicenter case-control study aims (1) to evaluate the prevalence of asymptomatic vertebral fractures in individuals with type 1 diabetes in comparison to age- and sex-matched healthy controls; (2) to compare individuals with diabetes with vertebral fractures and those without vertebral fracture using clinical, biochemical and radiological parameters.

NCT ID: NCT04032054 Not yet recruiting - Spine Fracture Clinical Trials

Comparison of Short Segment Mono-axial and Poly-axial Pedicle Screw Fixation for Thoracolumbar Fractures

Start date: October 1, 2019
Phase:
Study type: Observational

Comparison of short segment mono axial and poly axial pedicle screw fixation in thoracolumbar fractures regarding the best correction of the fracture and deformity and the maintenance of the correction.

NCT ID: NCT03967704 Completed - Clinical trials for Osteoporotic Fractures

Optimization of Follow-up of Patients With Symptomatic Recent Osteoporotic Vertebral Fracture

OPTIVERT
Start date: January 8, 2019
Phase: N/A
Study type: Interventional

The management of osteoporotic fractures has recently changed with the emergence of new programs dedicated to the diagnosis and treatment of osteoporosis. For example, the Fracture Network of the Paris Saint-Joseph Hospital Group, created in 2015, identifies and ensures the care of patients who have consulted emergency rooms for osteoporotic fractures. Within this sector, the vertebral fracture (VF) appears to be the most frequent (22.4%) ahead of other fracture sites, confirming the results of other studies that consider VF as a real public health problem. Osteoporotic vertebral fractures (OVF) have certain specificities compared to other osteoporotic fractures, encouraging particular interest.

NCT ID: NCT03911492 Recruiting - Clinical trials for Spinal Cord Injuries

Canadian-American Spinal Cord Perfusion Pressure and Biomarker Study

CASPER
Start date: August 31, 2019
Phase: N/A
Study type: Interventional

This multicenter study will enroll 100 patients with acute traumatic cervical and thoracic SCI who have a lumbar intrathecal catheter inserted within 24 hours of their injury. The lumbar intrathecal catheter will be inserted pre-operatively for the measurement of ITP and the collection of cerebrospinal fluid (CSF) samples. SCPP will be calculated as the difference between MAP and the ITP. There are two important distinct yet related objectives in this prospective interventional study. 1. Determine the effect of SCPP maintenance ≥ 65 mmHg in acute SCI on neurologic recovery as measured by ASIA Impairment Scale (AIS) grade conversion and motor score improvement. 2. Collect CSF and blood samples for the measurement of neurochemical biomarkers and storage for future biomarker discovery and validation studies.

NCT ID: NCT03885466 Completed - Osteoporosis Clinical Trials

Nordic Walking for Individuals With Osteoporosis, Vertebral Fracture or Hyperkyphosis

Start date: October 18, 2019
Phase: N/A
Study type: Interventional

Nordic walking is currently offered by a number of health care practitioners as a form of exercise therapy for older adults at risk of fracture. These include older individuals with osteoporosis, previous vertebral fracture, or hyperkyphosis. To the investigators knowledge, this practice is not evidence-based and thus potentially problematic as benefits and safety of Nordic walking for individuals with osteoporosis, fractures, or hyperkyphosis are unknown. The proposed study will answer the following principal question: Does Nordic walking improve mobility, physical function, posture, and quality of life for ambulant community dwelling individuals who have osteoporosis, a history of osteoporotic fracture, or hyperkyphosis? Participants will be randomized into either the Nordic walking intervention group, or the waiting-list control group. Participants will initially train 3 times per week for 3 months, led by peer- and/or student-instructors. The Nordic walking training will depend on the participant's skill and comfort level and will consist of walking with poles over a distance set individually for each participant. The control group will receive the same 3-month Nordic walking intervention after their control follow-up measurements are completed.

NCT ID: NCT03850938 Recruiting - Spine Fracture Clinical Trials

Percutaneous Kyphoplasty Using Rotary Cutter in Osteoporotic Vertebral Fractures

Start date: May 1, 2019
Phase: N/A
Study type: Interventional

Kyphoplasty(PKP) is performed under general anaesthesia in patients with osteoporotic vertebral compression fracture. The balloon is first placed into the fractured vertebra and inflated with contrast agent for height restoration. Then, the cement is injected into the cavity created by the balloon. As the diffusion of cement can be interfered by closely barriers formed by surrounding cancellous bones, refractures are often found in patients with conventional PKP. Furthermore, the loss of restored height of surgical vertebrae due to refracture in PKP. The investigators will applied a rotary cutter to destroy the structure of the cavity created by the balloon. Finally, the cement is injected, which may effectively interdigitates with the surrounding cancellous bone.

NCT ID: NCT03839732 Completed - Vertebral Fracture Clinical Trials

Observer Variability in Scoring Abdominal Aortic Calcifications and Vertebral Morphometry

CALCIFY2D
Start date: November 28, 2018
Phase:
Study type: Observational

BACKGROUND In the context of a progressively aging population, monitoring the status of Vascular Calcifications (VC) and Vertebral Fractures (VF) over time would be of primary importance, as VC and VF are recognized to be hallmarks of severe cardiovascular events (hospitalization and/or death) and hip fractures respectively, and VF represent an under-diagnosed cause of progressive disability and pain on its own. Moreover, there is an acknowledged relationships between VC and VF. However, data about the emergence/progression of VC and the emergence/worsening of VF over time are lacking. This is likely due to the absence of monitoring instruments for VC and VF that are both precise and easily accessible/applicable. OBJECTIVE This study aims to define the observer variability of a new software developed by the study sponsor and collaborators, called Calcify2D. Calcify2D offers physicians a computer-assisted procedure to simultaneously score vascular calcifications at the abdominal aorta and lumbar vertebral fractures (according to Quantitative Vertebral Morphometry principles) based on a latero-lateral thoracolumbar spine radiography. Secondary aims are the validation of the scores obtained from latero-lateral thoracolumbar spine radiography with more invasive and/or costly gold-standard imaging modalities (Computed Tomography for VC, Magnetic Resonance for VF) that may have been acquired near-simultaneously to radiographs on the patients enrolled for the study. STUDY DESIGN Not-for-profit monocentric observational study to be conducted on the diagnostic images of the thoracolumbar spine already collected at Istituto Ortopedico Rizzoli (IOR) within a previous interventional study. Scoring of VC and VF will be performed by four clinicians from four relevant specialties, chosen among those who may often see VC and VF and are already familiar with the traditional scoring systems for both VC and VF (one radiologist and one spine orthopaedics from IOR, one nephrologist from the National Research Council and one internist from University of Padua). Each clinician will assess all radiographs to score VC and QVM, both via computer assisted procedures and via traditional visual inspection. To avoid bias, an interval of at least one week will be left between the computer assisted and visual scoring. To define intra-observer variability (i.e. repeatability), the whole dataset will be re-assessed three times.

NCT ID: NCT03811873 Completed - Clinical trials for Transplant-Related Disorder

Assessment of Vertebral Fracture Risk for First Time Liver Transplant Candidates

VFA
Start date: February 18, 2019
Phase: N/A
Study type: Interventional

The researchers are trying to compare the effectiveness of Vertebral Fracture Assessment (VFA) in addition to the current standard of care spine x-ray in evaluation pre-liver transplant patients.

NCT ID: NCT03798444 Completed - Clinical trials for Osteoporosis Fracture

Height Loss, Kyphosis Indicators, Bone Mineral Density and Vertebral Fractures in Chinese Postmenopausal Women

Start date: September 1, 2017
Phase:
Study type: Observational

This is an observational and cross-sectional study on the height loss, kyphosis indicators, bone mineral density and vertebral fractures in Chinese postmenopausal women

NCT ID: NCT03730207 Completed - Clinical trials for Pathological Fracture of Vertebra Due to Secondary Osteoporosis (Disorder)

Xpede Clinical Study

Start date: December 18, 2018
Phase: N/A
Study type: Interventional

The purpose of this clinical study is to confirm the efficacy and safety of the Kyphon®Xpede™ Bone Cement in human use in China.