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Vertebral Fracture clinical trials

View clinical trials related to Vertebral Fracture.

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NCT ID: NCT05803681 Completed - Vertebral Fracture Clinical Trials

CCEF in the Treatment of Acute VFFs: Randomized Controlled Trial

Start date: January 1, 2015
Phase: N/A
Study type: Interventional

in recent years the search for therapeutic protocols that could enhance the VFFs healing, thus reducing bed rest-related complications and improving the quality of life of osteoporotic patients. In this context, biophysical stimulation with Capacitively Coupling Electric Fields (CCEF) together, antiresorptive therapy, vitamin D supplementation, and analgesic drugs could play a central role. CCEF is a non-invasive type of biophysical stimulation used to enhance fracture repair and spinal fusion. Positive effects of CCEF have been reported in osteoporotic vertebral fractures to resolve chronic pain and in postoperative pain, disability, and quality of life after spinal fusion In a preliminary observational study, Piazzolla et al. showed a significantly faster VBME resolution and back pain improvement in patients suffering from VFFs.

NCT ID: NCT05526794 Completed - Vertebral Fracture Clinical Trials

Anesthesia Methods on Percutaneous Kyphoplasty

Start date: January 1, 2022
Phase:
Study type: Observational [Patient Registry]

The aim of this research is to examine the effects of the anesthesia method and preoperative characteristics on postoperative results and complications in patients who underwent percutaneous kyphoplasty (PKP). Method: Patients were split into three groups according to anesthesia methods: (1) General Anesthesia (Sedation), (2) Central Block (Spinal and Epidural Anesthesia), (3) Peripheral Block [Erector Spina Plane Block (ESPB), and Paravertebral Block (PVB)]. Patients' pain values, hemodynamic parameters, additional need for sedation, and perioperative and postoperative complications were recorded prospectively together with Visual Pain Scales (VAS).

NCT ID: NCT05227976 Completed - Osteoporosis Clinical Trials

Patient Education With or Without Physical Training or Mindfulness and Medical Yoga in Established Spinal Osteoporosis

Start date: March 15, 2018
Phase: N/A
Study type: Interventional

In the present feasibility and pilot study we aim to investigate the effect and safety of patient education with or without additional physical training or mindfulness/medical yoga in patients with manifest spinal osteoporosis (at least one vertebral fracture). The study includes a 10-week intervention period with once weekly theory education with or without additional physical training or mindfulness/medical yoga (randomized groups). Furthermore, a proceeding observation period of 10 weeks as well as a 1-year follow up post-intervention observation are included in the study design.

NCT ID: NCT05071625 Completed - Vertebral Fracture Clinical Trials

CT Guided Percutaneous Vertebroplasty for Vertebral Non-union Following Posterior Fixation

Start date: March 31, 2019
Phase:
Study type: Observational

Traumatic thoracolumbar vertebral fractures are frequently treated with posterior fixation (PF) and vertebral augmentation, but sometimes vertebral augmentation is not performed, being judged too risky under fluoroscopic guidance alone. An adjuvant CT/fluoroscopy guided percutaneous vertebroplasty (PVP) could be an option. The aim was to evaluate feasibility, safety and effectiveness of PVP in patients with vertebral non-union (VNU) following PF performed without concomitant vertebral augmentation. All patients treated in our institution with PVP between July 2015-July 2020 were retrospectively reviewed. Patients treated with CT/fluoroscopy guided PVP under local anesthesia for symptomatic VNU following PF were selected. Three criteria were established to assess cement distribution, considering vertebral filling of: 1)fracture cleft, 2)anterior two-thirds of the vertebral body, 3)from superior to inferior endplates. Numeric pain rating scale (NPRS) assessing grade of discomfort (0=no pain; 10=worst pain) and complications were evaluated before and one month after PVP.

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: 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: NCT04413448 Completed - Clinical trials for Rheumatoid Arthritis

Performance of CT Parameters Compared to Bone Mineral Density to Detect Bone Fragility in Rheumatoid Arthritis

Start date: January 1, 2020
Phase:
Study type: Observational

Objective: To evaluate the performance of CT parameters (SBAC-L1 and fractal analysis) compared to BMD (gold standard) to detect vertebral fractures in rheumatoid arthritis

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: 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: NCT03617094 Completed - Vertebral Fracture Clinical Trials

Early Percutaneous Vertebroplasty Versus Standard Conservative Treatment in Thoracolumbar Vertebral Fractures

AGIL11
Start date: July 5, 2018
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate the efficacy of carrying out early vertebroplasty procedure, compared to the standard conservative treatment (corset), in order to prevent residual deformations that could occur in complications of vertebral fractures that are medically treated using a corset. This is a monocentric, randomized, parallel group, prospective and open-label study.