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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01609712
Other study ID # B-O-P-LF-01
Secondary ID B-O-P-LF-02
Status Recruiting
Phase N/A
First received May 29, 2012
Last updated June 3, 2012
Start date May 2012

Study information

Verified date June 2012
Source University Hospital, Bonn
Contact Robert Pflugmacher, M.D.
Phone +4915158233263
Email robert.pflugmacher@googlemail.com
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 50 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Germany Orthopädie und Unfallchirurgie Universitätsklinikum Bonn Bonn NRW

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Bonn

Country where clinical trial is conducted

Germany, 

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