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

Study Overview
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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.

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

Conditions
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Osteoporotic Vertebral Compression Fractures, Lung Function

Intervention / Treatment
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* Procedure: Radiofrequency Kyphoplasty


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient with vertebral compression fracture<br>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. | Procedure: Radiofrequency Kyphoplasty<br>* 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.<br>* Other names: RF-Kyphoplasty;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Improvement of lung function (FEV1, PEF), Visual Analog Scale, Oswestry Disability Index, Radiographs pre and post Op