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

Lung Function Clinical Trial

Official title:

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

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
• 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

• Fractures, Bone
• Fractures, Compression
• Lung Function
• Osteoporotic Vertebral Compression Fractures

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,