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Vertebral Fracture clinical trials

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NCT ID: NCT03263585 Completed - Osteoporosis Clinical Trials

Treatment With a Spinal Orthosis Compared to Equipment Group Training and a Control Group

Start date: May 3, 2012
Phase: N/A
Study type: Interventional

Background: Back pain and osteoporosis with vertebral fractures are common conditions in elderly women and significantly affect their quality of life. A common complication of osteoporosis are vertebral fractures. Treatment with bone-specific drugs does often not help the pain condition caused by the vertebral fractures even when the progress of the disease has decreased. Vertebral fractures often result in deformation of the spine and poorer quality of life of the individual. The spinal kyphosis also affects the lung function and the effect of the kyphosis itself is severe. Alternative treatments of back pain may lead to reduced drug demand for pain. Physical activity is one of the most important factors that regulates bone mass and can also affect balance and fall risk positively. The back orthosis that we intend to use in the treatment study has been shown in some previous scientific studies to strengthen the muscles in the back and also decrease the pain. Purpose: The purpose of the study was to evaluate the effect of treatment of back pain in elderly women with an activating functional orthosis versus treatment with a group of physiotherapeutic tools and a control group for a six-month treatment period and follow-up after 12 months from the start of study. The aim was also to study elderly women with osteoporosis and back pain in a follow-up study of a cohort of women at high risk of osteoporotic fractures, with focus on back pain, functional capacity and quality of life. The aim was to study the effect of treatment with activating functional orthosis versus physiotherapeutic treatment in a group and a control group without treatment. The main outcomes will be the experienced perceived back pain and back extensor strength. Additional outcomes will be quality of life, balance, lung function and kyphosis. Biochemical markers for pain will be measured in the RCT (Randomized Controlled Trial). Significance: Evaluation of alternative treatment methods such as exercise by a physiotherapist and treatment with a functional orthosis will give new additional treatment options for our patients. An activating functional orthosis could reduce the use of analgesics and increase the quality of life of the affected women.

NCT ID: NCT03008902 Completed - Vertebral Fracture Clinical Trials

A Study of Effects of Age and Hyperkyphosis on Spine Motion and Loading

Start date: April 18, 2017
Phase:
Study type: Observational

We are studying how spine movement changes with age, and when people have vertebral fractures (cracks in the bones of the spine) or hyperkyphosis (a forward stooped posture).

NCT ID: NCT02963571 Completed - Vertebral Fracture Clinical Trials

Posterior Percutaneous Pedicle Screw Fixation for Acute Thoracolumbar Vertebral Fractures

Start date: August 2010
Phase: N/A
Study type: Interventional

To validate the safety and effectiveness of minimally invasive posterior percutaneous pedicle screw fixation in acute thoracolumbar vertebral fractures with simple anterior spinal column injury.

NCT ID: NCT02536898 Completed - Hip Fracture Clinical Trials

Norwegian Capture the Fracture Initiative

NoFRACT
Start date: May 2015
Phase: N/A
Study type: Interventional

The main aim is to assess the effectiveness of introducing a standardized intervention program for treatment of patients with a fragility fracture as measured by changes in the fracture rates and the mortality.

NCT ID: NCT01963039 Completed - Osteoporosis Clinical Trials

A Trial of Vertebroplasty for Painful Chronic Osteoporotic Vertebral Fractures (Vertos V)

VERTOSV
Start date: May 2013
Phase: N/A
Study type: Interventional

Background The standard care in patients with a painful osteoporotic vertebral compression fracture (VCF) is conservative therapy. Percutaneous vertebroplasty (PV), a minimally invasive technique, is a relatively new treatment option. Recent randomized controlled trials (RCT) provide conflicting results: two sham-controlled studies showed no benefit of PV while an unmasked but controlled RCT (VERTOS II) found effective pain relief at acceptable costs in patients with acute VCFs. A still ongoing masked RCT (VERTOS IV) focuses on acute VCFs defined as ≤ 6 weeks. VERTOS III focused on conservative treatment and found that half of patients still had disabling pain after 3 months or longer. These patients with sustained pain after 3 months may benefit from PV. Objective To compare pain relief after PV with a sham intervention in selected patients with a chronic osteoporotic VCF ( three months or longer) using the same strict inclusion criteria as in VERTOS II an IV. Secondary outcome measures are back pain related disability and quality of life. Methods The VERTOS V study is a prospective RCT with pain relief as primary endpoint. Inclusion criteria are a VCF of thoracic level 5 or lower with focal tenderness at fracture level, assessed by an internist on physical examination and a Visual Analogue Scale (VAS) score ≥ 5 for three months or longer, decreased bone density defined as T score ≤ -1 and age 50 years or older. 94 patients will be included, 47 in each arm. Crossovers are not allowed. Follow-up is at regular intervals during one year period with VAS score for pain as primary endpoint. Secondary endpoints are back pain related disability and quality of life measured with the Quality of Life Questionnaire of the European Foundation for Osteoporosis and physical function measured with the Roland Morris Disability questionnaire. Conclusion Vertos V is a methodologically sound masked randomised sham controlled trial of vertebroplasty in patients with sustained pain 3 months or longer after a vertebral compression fracture.

NCT ID: NCT01839682 Completed - Osteoporosis Clinical Trials

Evaluation of Outcomes of DFine StabiliT Kyphoplasty in Vertebral Compression Fractures Due to Osteoporosis

Start date: June 2009
Phase: N/A
Study type: Observational

This post-market surveillance research project consists of data collection at specified time points using standard questionnaire instruments to compare pain level, mobility and function pre and post procedure using the D-Fine StabiliT® Vertebral Augmentation System and StabiliT® Bone Cement, an FDA approved product used in the standard treatment of vertebral compression fractures.

NCT ID: NCT01817933 Completed - Hip Fractures Clinical Trials

Integrated Rehabilitation Program for Fractures

Start date: July 2010
Phase: N/A
Study type: Interventional

The recovery of range of motion and muscle power after surgical intervention of the fracture will mostly affect patient's daily activities. So postoperative rehabilitation program will play the important role. Correct and effective physical therapy will reduce the functional impairment of limbs after long term casting or surgical fixation, and accelerate to recover the independent daily activities. There is no consensus between immediate or delay and the duration of continue physical therapy will improve the shoulder function、muscle power and degree of satisfaction( physiological function、social function、mental health、 pain、 general health status ) after surgical fixation of fractures. This study will evaluate the patients of the fracture that including of the humeral neck fracture, vertebral fracture, distal radial fracture and hip fractures after surgical fixation, to see the difference of fracture healing time, function recovery and pain sensation after intervention of physical therapy at different time point. From this study, we hope to discriminate the timing of intervention and duration of physical therapy which is the key factors for postoperative prognosis of fractures fixation, and to set up the perfect rehabilitation program in ChangHua Christian Hospital. The results of this study will improve the discomfort of fracture patient's recovery or reduce the complications rate, and set up the standard treatment policy of our hospital , also was the model of other hospitals.

NCT ID: NCT01266200 Completed - Vertebral Fracture Clinical Trials

Identification of Microcirculation and Inflammation After Posterior Stabilization of the Spine

MicroSpine
Start date: December 2010
Phase: N/A
Study type: Interventional

In this project, with unstable vertebral fractures, the microcirculation of the skin and muscle (O2C,Laser-Doppler/White-light -Spectroscopy and contrast-enhanced sonography) will be evaluated in both conventional and in percutaneous minimally invasive technique (XIA versus Mantis) at the thoracolumbar junction.

NCT ID: NCT01200277 Completed - Osteoporosis Clinical Trials

A Trial of Vertebroplasty for Painful Acute Osteoporotic Vertebral Fractures

VertosIV
Start date: January 2011
Phase: Phase 3
Study type: Interventional

The standard care in patients with a painful osteoporotic vertebral compression fracture (VCF) is conservative therapy. Percutaneous vertebroplasty (PV), is a new minimally invasive technique for pain treatment in which bone cement is injected in the fractured vertebra. Recent RCTs provide conflicting results: two sham-controlled studies show no benefit of PV while an unmasked but controlled RCT found significantly better pain relief after PV at acceptable costs.

NCT ID: NCT01120197 Completed - Osteoporosis Clinical Trials

Study of Effect of Exercise With Osteoporosis and Vertebral Fracture

Start date: May 2005
Phase: N/A
Study type: Interventional

The aim of this randomized controlled trial is to evaluate the effectiveness for health-related quality of life (HRQOL) of a 3-month course of exercises for a group of postmenopausal women with osteoporosis who has at least one vertebral fracture versus a control group (undertaking their usual activities). The course of exercises is devised in accordance with methods recommended in "Rehabilitation treatment guidelines in postmenopausal and senile osteoporosis".