Postrual Reduction With Pillow in Osteoporotic Vertebral Fracture

Study Overview
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Brief Summary
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Vertebroplasty in the symptomatic osteoporotic vertebral fracture has become increasingly popular. However, there have been some limitations in restoring the height of the collapsed vertebrae and in preventing the leaking of cement. In the severely collapsed vertebrae of more than two thirds of their original height, vertebroplasty is regarded as a contraindication. We tried postural reduction using a soft pillow under the compressed level. This study was undertaken to investigate the effectiveness of the combination of postural reduction and vertebroplasty for re-expansion and stabilization of the osteoporotic vertebral fractures. single level vertebral compression fracture were treated with postural reduction followed by vertebroplasty. We analyzed the degree of re-expansion according to the onset duration.

Official Title
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Postrual Reduction With Pillow in Osteoporotic Vertebral Fractures: a Randomized, Prospective Study

Conditions
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Compression Fracture Spine, Osteoporosis Fracture

Intervention / Treatment
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* Other: Pillow


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Single level osteoporotic compression fracture of thoracic and lumbar spine Exclusion Criteria: Can't tolerate the postural reduction by pillow Pathological spine fracture caused by tumor, infection. Multiple spine fractures Patient presented with neurological. deficits

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Patients with single level osteoporotic compression fracture
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pillow group<br>Before surgery, with the patient lying in the supine position, a soft pillow was placed under the segment of the collapsed vertebrae, which resulted in a hyperextension position. 12 hours duration suggested from 11:00 pm 1 night before the surgery till next day. | Other: Pillow<br>* A soft pillow was placed under the segment of the collapsed vertebrae, which resulted in a hyperextension position<br>|
| No Intervention: No pillow group<br>No intervention was given in this group before surgery. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sagittal plane contour | Sagittal plane measurement by measuring the Cobb angle of the injured vertebral on lateral radio-graphs | 6 months of post-operative follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional outcome | Visual Analogue Scale This is a pain scale, 10 scoes is the worest pain ever. 0 scores is no pain | 6 months of post-operative follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Compression fracture, postural reduction, vertebroplasty