Text Size

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

This study is currently recruiting participants.
Verified June 2012 by University Hospital, Bonn
Sponsor:
Information provided by (Responsible Party):
Robert Pflugmacher, University Hospital, Bonn
ClinicalTrials.gov Identifier:
NCT01609712
First received: May 29, 2012
Last updated: June 3, 2012
Last verified: June 2012
History of Changes
  Purpose

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 Intervention
Osteoporotic Vertebral Compression Fractures
Lung Function
 Procedure: Radiofrequency Kyphoplasty

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Osteoporotic Vertebral Compression Fractures: Can Kyphoplasty Improve Lung Function? A Prospective Evaluation

Resource links provided by NLM:

MedlinePlus related topics: Fractures
U.S. FDA Resources

Further study details as provided by University Hospital, Bonn:

Estimated Enrollment: 30
Study Start Date: May 2012
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with osteoporotic compression fractures, mostly elderly females

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01609712

Contacts
Contact: Robert Pflugmacher, M.D. +4915158233263 robert.pflugmacher@googlemail.com
Contact: Rahel Bornemann +49-160-2535164 rahel.bornemann@googlemail.com

Locations
Germany
Orthopädie und Unfallchirurgie Universitätsklinikum Bonn Recruiting
Bonn, NRW, Germany, 53127
Contact: Robert Pflugmacher, M.D.     +49-151-58233263     robert.pflugmacher@googlemail.com    
Sponsors and Collaborators
University Hospital, Bonn
Investigators
Principal Investigator: Robert Pflugmacher, M.D. Orthopädie und Unfallchirurgie, Universitätsklinkum Bonn
  More Information

No publications provided

Responsible Party: Robert Pflugmacher, PD Dr. med., University Hospital, Bonn
ClinicalTrials.gov Identifier: NCT01609712     History of Changes
Other Study ID Numbers: B-O-P-LF-01, B-O-P-LF-02
Study First Received: May 29, 2012
Last Updated: June 3, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by 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

ClinicalTrials.gov processed this record on May 16, 2013