Osteoporotic Vertebral Compression Fractures: Can Kyphoplasty Improve Lung Function? A Prospective Evaluation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-31

Brief Summary

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Patients with vertebral fractures often have problems to straighten and as a consequence of impaired lung ventilation that leads to a impaired lung function. Furthermore, it comes to the sintering of the vertebra and a so-called hunchback. This also contributes to the poorer expansion of the lung. Pain is also caused by respiratory excursions of the chest which hinder the patients to use their entire lung volume.

Kyphoplasty is designed to counter all these consequences of vertebral fractures by bringing stability to the fracture.

In order to prove the thesis the results of lung function test (FEV1, PEF) are assessed.

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Detailed Description

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Conditions

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Osteoporotic Vertebral Compression Fractures Lung Function

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patient with vertebral compression fracture

RF kyphoplasty is standard of care in our hospital for patients with osteoporortic compression fractures. We are intersetd, if it also can improve the lung function.

Radiofrequency Kyphoplasty

Intervention Type PROCEDURE

Radiofrequency kyphoplasty is a new form of surgical treatment. It injects an ultrahigh viscosity cement into the fractured vertebral body, using radiofrequency to achieve the proper consistency of the cement. This ultrahigh viscosity cement is designed to first restore proper height and alignment to the fractured vertebra and then to stabilize the fracture, thereby preventing further intravertebral motion and reducing pain.

The RF-Kyphoplasty is standard of care in our hospital. It is FDA and CE approved.

Interventions

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Radiofrequency Kyphoplasty

Radiofrequency kyphoplasty is a new form of surgical treatment. It injects an ultrahigh viscosity cement into the fractured vertebral body, using radiofrequency to achieve the proper consistency of the cement. This ultrahigh viscosity cement is designed to first restore proper height and alignment to the fractured vertebra and then to stabilize the fracture, thereby preventing further intravertebral motion and reducing pain.

The RF-Kyphoplasty is standard of care in our hospital. It is FDA and CE approved.

Intervention Type PROCEDURE

Other Intervention Names

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RF-Kyphoplasty

Eligibility Criteria

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Inclusion Criteria

* over 50 years
* VAS over 49, ODI over 29
* radiographic evidence of A 1.1, 1.2, 1.3 fractures
* patients mentally capable to sign informed consent

Exclusion Criteria

* high-energy trauma
* known tumor involvement
* osteonecrotic fractures
* burst fractures or pedicle fractures
* previous surgical treatment for a vertebral body compression fracture
* patient has paget's disease
* BMI \> 35
* uncontrolled diabetes HbAc1c \> 7%
* severe cardiopulmonary disease
* Myelopathy
* long-time steroid therapy

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No