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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01609712
Recruitment Status : Unknown
Verified June 2012 by Robert Pflugmacher, University Hospital, Bonn.
Recruitment status was:  Recruiting
First Posted : June 1, 2012
Last Update Posted : June 5, 2012
Information provided by (Responsible Party):
Robert Pflugmacher, University Hospital, Bonn

Brief Summary:

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.

Condition or disease Intervention/treatment
Osteoporotic Vertebral Compression Fractures Lung Function Procedure: Radiofrequency Kyphoplasty

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Osteoporotic Vertebral Compression Fractures: Can Kyphoplasty Improve Lung Function? A Prospective Evaluation
Study Start Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Group/Cohort Intervention/treatment
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.
Procedure: 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.

Other Name: RF-Kyphoplasty

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with osteoporotic compression fractures, mostly elderly females

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01609712

Contact: Robert Pflugmacher, M.D. +4915158233263
Contact: Rahel Bornemann +49-160-2535164

Orthopädie und Unfallchirurgie Universitätsklinikum Bonn Recruiting
Bonn, NRW, Germany, 53127
Contact: Robert Pflugmacher, M.D.    +49-151-58233263   
Sponsors and Collaborators
University Hospital, Bonn
Principal Investigator: Robert Pflugmacher, M.D. Orthopädie und Unfallchirurgie, Universitätsklinkum Bonn

Responsible Party: Robert Pflugmacher, PD Dr. med., University Hospital, Bonn Identifier: NCT01609712     History of Changes
Other Study ID Numbers: B-O-P-LF-01
B-O-P-LF-02 ( Other Identifier: UKB Bonn, Orthopädie und Unfallchirurgie, PD Dr. Robert Pflugmacher )
First Posted: June 1, 2012    Key Record Dates
Last Update Posted: June 5, 2012
Last Verified: June 2012

Keywords provided by Robert Pflugmacher, University Hospital, Bonn:
Improvement of lung function (FEV1, PEF)
Visual Analog Scale
Oswestry Disability Index
Radiographs pre and post Op

Additional relevant MeSH terms:
Fractures, Bone
Fractures, Compression
Wounds and Injuries