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

June 3, 2012 updated by: Robert Pflugmacher, University Hospital, Bonn

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
    • NRW
      • Bonn, NRW, Germany, 53127
        • Recruiting
        • Orthopädie und Unfallchirurgie Universitätsklinikum Bonn
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with osteoporotic compression fractures, mostly elderly females

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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 Names:
  • RF-Kyphoplasty

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bonn

Investigators

  • Principal Investigator: Robert Pflugmacher, M.D., Orthopädie und Unfallchirurgie, Universitätsklinkum Bonn

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Study Registration Dates

First Submitted

May 29, 2012

First Submitted That Met QC Criteria

May 31, 2012

First Posted (ESTIMATE)

June 1, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

June 5, 2012

Last Update Submitted That Met QC Criteria

June 3, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-O-P-LF-01
  • B-O-P-LF-02 (OTHER: UKB Bonn, Orthopädie und Unfallchirurgie, PD Dr. Robert Pflugmacher)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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