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Spinal Fractures clinical trials

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NCT ID: NCT02931266 Terminated - Spinal Fractures Clinical Trials

PASS MIS® Post-market Clinical Follow-up

Start date: September 2016
Phase:
Study type: Observational

Prospective, multicenter non comparative and observational study (post-market clinical follow-up).

NCT ID: NCT02918669 Completed - Spinal Fractures Clinical Trials

Study to Investigate the Long Term Survivorship of Coflex

Start date: April 2016
Phase: N/A
Study type: Interventional

Examine the long-term survivorship via CT Scan of the coflex in patients who presented with spinous process fracture(s) at 24 months in the Paradigm Spine coflex IDE Study.

NCT ID: NCT02880839 Active, not recruiting - Clinical trials for Cervical Spine Fracture

Digital Navigation Enhances Cervical Pedicle Screw Placement Accuracy and Safety

Start date: September 2013
Phase: N/A
Study type: Interventional

To compare the internal fixation results of three pedicle screw implantation methods and investigated the accuracy and safety of digital navigation-assisted pedicle screw placement.

NCT ID: NCT02840695 Completed - Clinical trials for Ankylosing Spondylitis

Effect of Biological Disease Modifying Anti Rheumatic Drug (bDMARD) Treatment on Spinal Fracture Incidence in Patients With Ankylosing Spondylitis (AS)

Start date: January 2005
Phase: N/A
Study type: Observational [Patient Registry]

Ankylosing spondylitis (AS) is a rheumatoid disease affecting all segments of the axial skeleton, leading to the complete fusion of all spinal segments - the bamboo-spine. During the last decade biological disease modifying anti-rheumatic drugs (bDMARD) have been successfully introduced to reduce the disease activity. It is unclear whether bDMARD treatment had an effect on spinal fracture risk related to AS. This national registry study will investigate the effect of bDMARD treatment on spinal fracture risk in a national cohort of patients with AS.

NCT ID: NCT02839057 Completed - Spinal Fractures Clinical Trials

Survival After Surgical Treatment of Axis Fractures in Elderly

Start date: October 2015
Phase: N/A
Study type: Observational [Patient Registry]

Fractures of the second cervical vertebra (C2) are the most common spinal fracture among the elderly. Non-surgical treatment comprises of cervical collar treatment for 12 weeks, while surgical treatment for elderly could mean posterior fixation C1-C2 without collar treatment or anterior screw osteosynthesis C2 with 6 weeks of collar treatment. A meta-analysis of retrospective studies has recently found an improved survival with surgical treatment. This national registry study is designed to estimate the survival of non-surgical and surgical treatment in a population-based cohort.

NCT ID: NCT02826889 Completed - Spondylolisthesis Clinical Trials

Assessing the Diagnostic Accuracy of Corrected Flow Time (FTc) and Pleth Variability Index (PVI) as Predictors of Fluid Responsiveness in Patients in the Prone Position Using the Jackson Table

Start date: May 24, 2016
Phase: N/A
Study type: Interventional

Appropriate fluid management is an important part of anesthesia in patients undergoing surgery, and several dynamic indices have been suggested to have high predictability for fluid responsiveness in patients receiving mechanical ventilation. Among various surgical positions, the prone position is known to cause unique physiologic and hemodynamic changes and affect the predictability and cut-off values of dynamic indices for fluid responsiveness. A previous study reported that pulse pressure variation (PPV) and corrected flow time were able to predict fluid responsiveness with relatively high accuracy in patients undergoing spine surgery in the prone position using a Wilson frame. However, the Jackson frame is known to have less effects on the cardiovascular system compared to the Wilson frame, and therefore may be physiologically more appropriate in patients undergoing surgery in the prone position. The pleth variability index (PVI) is a dynamic index that can be monitored non-invasively in patients under mechanical ventilation. The present study aims evaluate the validity of PPV and pleth variability index (PVI) as predictors of fluid responsiveness in the supine and prone positions in patients undergoing posterior lumbar spinal fusion using the Jackson table.

NCT ID: NCT02789774 Active, not recruiting - Spinal Fractures Clinical Trials

Uppsala Study on Odontoid Fracture Treatment in the Elderly

USOFT
Start date: February 2012
Phase: N/A
Study type: Interventional

A multicenter randomized controlled trial is performed in Sweden (Uppsala, Malmo and Stockholm) comparing surgery with posterior C1-C2 fusion and conservative treatment with a rigid collar. Follow up will be performed up to one year after start of treatment registering EQ5D, NDI and cervical CT scans. Mortality will be documented during follow-up. All direct and indirect costs of treatment will be registered and used for cost-effectiveness analysis.

NCT ID: NCT02788760 Terminated - Clinical trials for Collar Treatment of Stable Subaxial Spine Fractures

"The Length of Cervical Collar Treatment for Traumatic Sub-axial Fractures"

Start date: June 2016
Phase: N/A
Study type: Interventional

Most fractures of the cervical spine are considered stable and treated with a rigid cervical collar. However no studies have to date been published addressing the length of treatment. There seems to be a significant dissimilarity between hospitals within and between countries with the length of collar treatment varying from 6 to 12 weeks. At the neurosurgical department at Oslo University Hospital, Ullevål the standard length of treatment for a stable cervical fracture is 12 weeks. This study seeks to establish whether 6 weeks of collar treatment for a specific subtype of stable fractures in the cervical spine is sufficient.

NCT ID: NCT02784782 Recruiting - Spinal Fractures Clinical Trials

Thoracolumbar Burstfractures, Orthesis or No Orthesis

BONO
Start date: March 2016
Phase: Phase 4
Study type: Interventional

Rationale: Thoracolumbar burst fractures are frequently seen in the trauma population, they have a large impact on patient's wellbeing and are a large economic burden to society. Thoracolumbar burst fractures might not need the standard care of brace immobilization for adequate treatment and a functional treatment might lead to same or better functional outcomes. Besides that, with functional outcome length of hospital stay might decrease and it might also be cost effective compared to bracing. Objective: The investigators aim to study the use of braces for thoracolumbar burstfractures, not only by measuring the functional scores and the effect of the bracing or functional treatment on the increase in kyphosis angle, but also on (health related) quality of life and health economics. The investigators hypothesize that no treatment is superior over one other. Study design: This project is a randomised controlled trial comparing brace and no brace treatment on function, kyphosis angle, pain, quality of life, and costs. Study population: Patients between 18 and 65, with a single level thoracolumbar burst fracture will be included. The fracture has to have a kyphosis angle of less than 35 degrees and patient has to be neurologically intact. Patients are excluded when they are overweight (BMI> 35), need multidisciplinary treatment due to multitrauma, or have inadequate knowledge of the Dutch language. Patients included in the brace group will automatically take part in a brace compliance study. Intervention: One group receives a Thoracolumbar Sacral Orthesis (TLSO) for 6 weeks, the other group receives no TLSO Main study parameters/endpoints: The primary outcome of this study is the functional score at six months after trauma. Secondary outcomes are pain, kyphosis angle, health related quality of life, healthcare costs and brace compliance. Literature shows no difference in pain, functional outcome or kyphosis angle, therefore no potential risks are known comparing a brace and a functional treatment. Investigators aim that not using the TLSO results in similar functional outcome, pain and kyphosis angle, and less costs. Patients will be seen at first presentation and during two year follow up at the outpatient clinic at six standard care follow up moments. At these follow up moments a X-ray as part of standard care is made. At or just before each scheduled appointment they will fill in questionnaires taking from 15-45 minutes.

NCT ID: NCT02781974 Completed - Osteoporosis Clinical Trials

The Effect of Exercise on Physical Function in Older Women With Osteoporosis and a History of Vertebral Fracture

Start date: January 2016
Phase: N/A
Study type: Interventional

The study is a parallel-group single blinded randomized controlled trial, examining the effect of exercise on physical function in older women with osteoporosis and a history of vertebral fracture. The participants will randomly be assigned in a 1:1 ratio to the intervention group and the control group. The intervention will follow newly developed exercise recommendations for people with osteoporosis and vertebral fractures, which states the balance- and strength exercises should be performed at least twice a week. The intervention is a group exercise session circuit program lasting for 12 weeks. The participants will be tested at baseline, and followed up at 3 months and 6 months.