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

NCT01609712 | Unknown

• 2 other identifiers: B-O-P-LF-01B-O-P-LF-02
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporotic Vertebral Compression Fractures; Lung Function

Keywords

Improvement of lung function (FEV1, PEF); Visual Analog Scale; Oswestry Disability Index; Radiographs pre and post Op

Study Arms (1)

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

Interventions

Radiofrequency Kyphoplasty PROCEDURE

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.

Also known as: RF-Kyphoplasty

Patient with vertebral compression fracture

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with osteoporotic compression fractures, mostly elderly females

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bonn: lead

Study Sites (1)

Orthopädie und Unfallchirurgie Universitätsklinikum Bonn

Bonn, North Rhine-Westphalia, 53127, Germany

RECRUITING

Study Officials

• Robert Pflugmacher, M.D.

  Orthopädie und Unfallchirurgie, Universitätsklinkum Bonn

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Pflugmacher, M.D.

CONTACT

+4915158233263; robert.pflugmacher@googlemail.com

Rahel Bornemann

CONTACT

+49-160-2535164; rahel.bornemann@googlemail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. med.

Study Record Dates

• First Submitted: May 29, 2012
• First Posted: June 1, 2012
• Study Start: May 1, 2012
• Last Updated: June 5, 2012

Record last verified: 2012-06

Locations

DE (1)